Complete Operator Training Manual PDF
Complete Operator Training Manual PDF
Complete Operator Training Manual PDF
SW Version 3.4
COBAS INTEGRA 400 plus
Table of contents
1 Configuration guide
2 Hardware overview
3 Test run
4 Configuration
5 Orders
6 Results
7 Service
8 ISE
10 DAT
11 TDM
12 HbA1C
Roche Diagnostics
i
COBAS INTEGRA 400 plus
Roche Diagnostics
ii
COBAS INTEGRA® 400 plus
Configuration Guide
Software Version 3.4
Revision history
Publication notice
This publication is for support personnel of the COBAS INTEGRA® 400 plus.
Every effort has been made to ensure that all the information contained in this
publication is correct at the time of publishing. However, Roche Diagnostics GmbH
reserves the right to make any changes necessary without notice as part of ongoing
product developments and improvements.
Any customer modification to the instrument will render the warranty or service
agreement null and void.
Intended use The COBAS INTEGRA 400 plus is a fully automated, computerized chemistry
analyzer. It is intended for in vitro quantitative or qualitative determination of a wide
range of analytes in various body fluids.
Instrument approvals Our instruments meet the requirements laid down in IVD Directive 98/79/EC and the
European Standard prEN 591. Furthermore, our instruments are manufactured and
tested according to the international standard IEC 61010-1 (EN 61010-1).
Compliance is demonstrated by the following marks:
Configuration Overview
A
This chapter provides an overview of the configuration tasks, and it gives hints and
tips for typical operation scenarios.
A
A
A
Test configuration
The following sections represent the logical progression of steps for loading and
configuring tests.
For many of the steps, you find more detailed information in the sections of Chapter 2
“System configuration”.
1 Configuration / Controls
1 Click Load.
2 Specify the path where the source files are located (default path: C:/Roche/
Instrument/TAS) and select the controls to be installed.
2 Configuration / Tests
a To load tests
1 Click Load.
2 Specify the path where the source files are located. (Default path: C:/Roche/
Instrument/TAS.)
3 Select the tests to be installed.
3 Configuration / Tests
General tab 1 Modify Default Sample Type by selecting an alternative sample type from the list.
2 Modify the calibration interval, if required.
3 Select Clot detection. (Is set by default, except with HEM1W and HEM2W.)
You should not change the default calibration intervals.
Since SW 3.4 is the parameter for calibrator a Roche parameter and not changeable anymore for
the user, the calibrator is still visual but ghosted. The same is valid for the 5 hours main interval
calibration for ISE.
9% NaCl can only be used in the ready to use 25ml NaCl bottles placed on the ISE-rack. It is not
possible anymore to use 9% NaCl in a 10ml bottle and placed on the ISE-rack.
Control tab 1 Select QC Treatment to ensure that each control is checked according to Precision,
Accuracy or Limit rules as defined in Configuration / Database / QC Mode.
2 Select the controls to be used.
You can select up to 6 controls for each test.
3 Select After Cal for the control to be automatically performed after a calibration,
independently of whether the interval is selected or not.
4 Select Interval (tests or hours) and Interval Sequence if controls are to be
performed automatically.
Prior to defining this table, the laboratory must decide if it prefers to request controls manually or
to work with automated control intervals
Laboratory tab 1 Enter Correlation Factor and Offset if correlating two different methods.
2 Enter Lab Unit and Factor if lab units are different from standard units.
When you enter and save the Lab Unit factor, entry fields for calibrator values and control values
are displayed in the new lab units. Therefore enter these values as lab units and not as standard
units.
However, if you entered calibration and controls values as standard units before entering and
saving the lab unit factor, then these values are automatically converted to the new lab units.
If a barcode pen is used for entry of lot values, these values are automatically converted and
displayed in Lab Units.
New Feature with SW 2.3/3.3: Peak and trough ranges can be defined.
TDM is measuring the concentration of drugs in serum or plasma to monitor and adjust drug
therapy in patients. There must be a relationship between the serum concentration of a durg
and it‘s pharmacological effect.
TDM is performed to ensure drug levels are within the therapeutic range
o Therapeutic range refers to serum levels in which minimum toxicity risk is achieved with therapeutic effect
o Below range, therapy most likely ineffective
o Above range, toxic side effects without improved effectiveness most likely
Test Groups tab o Create new test groups to reduce the number of test buttons displayed in the
Orders work area.
Test Sequences tab o Select alphabetical (default), Test Classes or Custom to arrange the way buttons are
displayed in the Orders work area.
Test Classes tab o Tests are automatically allocated to their predefined specific test class. Create a new
test class if necessary. Add or remove tests from classes in this area.
Test classes are used in the Result Handling Table for flag handling.
New Feature with SW 2.3/3.3: Profiles and Calculated Results can be loaded automatically from
TAS.
5 Configuration / Profiles
Following Profiles are available:
ACPP-ACPP Profile for ACP and NPACP
CHEDN-CHE DIBUCAINE NUMBER for CHE-D and CHE-T
HBA1c- HB/HBA1c-Profile for HEM1and HEM2
HEMWP- HB/HBA1c-Profile Whole Blood for HEM1W and HEM2W
ISE-D- ISE-Direct for Cl-D, K-D, Li-D and Na-D
ISE-I- ISE-Indirect for Cl-I, K-I and Na-I
ISE-U- ISE-Urine for Cl-U, K-U and Na-U
1 Click Load.
2 Specify the path where the source files are located. (Default path: C:/Roche/
Instrument/TAS.)
Select the Profile to be installed
Test tab o Selected the tests required for the profile are shown.
To define a calculated result, perform the steps described for each tab.
1 Click Load.
2 Specify the path where the source files are located. (Default path: C:/Roche/
Instrument/TAS.)
Select the calculate result to be installed
Formula tab 1 Select tests required in the formula in A, B, C, D fields and the factors in w, x, y, z
fields, if required.
2 Type the formula for the calculated results using A, B, C, D and w, x, y, z in the
Formula field, if required.
Laboratory tab 1 Enter Correlation Factor and Offset if correlating two different methods, if
required.
2 Enter Calculated Result (Ratio) Unit and Factor/Offset if the lab units are different
from specified units, if required.
3 Enter the number of decimal places to be displayed in results
Formula tab 1 Select tests required in the formula in A, B, C, D fields and the factors in w, x, y, z
fields.
2 Type the formula for the calculated results using A, B, C, D and w, x, y, z in the
Formula field.
Laboratory tab 1 Enter Correlation Factor and Offset if correlating two different methods.
2 Enter Calculated Result (Ratio) Unit and Factor/Offset if the lab units are different
from specified units.
3 Enter the number of decimal places to be displayed in results.
7 Configuration / Calibrators
ID tab All calibrators required for all loaded tests are automatically read from the Calibrator
list.
1 Modify the short name (up to eight alphanumeric characters), if required.
The short name is the calibrator name displayed in the user interface, for example
in the Orders and Results work areas.
2 Modify the long name (up to 30 alphanumeric characters), if required.
1 For each calibrator, click New Lot and enter the lot number (up to ten
alphanumeric characters) and expiry date.
2 Click Save to show the tests in the test list that require that calibrator.
3 For each test in the test list, enter the concentration of the calibrator(s).
Since SW Version 3.4 it is possible to enter seperate the lot Nomber and Expiration Date of
SOL-1. SOL-2 and SOL-3
a To enter the calibrator lot number, expiry date and values using the barcode pen
8 Configuration / Controls
1 For each control, click New Lot and enter the lot number (up to ten alphanumeric
characters) and expiry date.
2 Click Save to show the tests in the test list that require that control.
3 For each test in the test list, select whether the control is a precision and/or
accuracy control (or limit control for DATs).
4 Enter the assigned mean and SD (precision control), assigned value and
permissible deviation (accuracy control) or upper and lower limits (limit control).
a To enter the control lot number, expiry date and values for accuracy controls
using the barcode pen
9 Configuration / Cleaners
1 Click Load.
2 Specify the path where the source file is located (default path: C:/Roche/
Instrument/TAS).
3 Select the cleaner definition Clean to be installed.
All required Extra Wash Cycles should load automatically when the tests are loaded.
Whenever new tests are added to the current list, the Extra Wash Cycles is automatically loaded .
1 Select the ISE rack on which to reserve positions for the ISE solutions, cleaners
and/or diluents.
2 Assign the positions by dragging the items to the appropriate position.
3 Select the CalQC racks on which to reserve positions for the calibrators, controls,
cleaners and/or diluents.
4 Assign the positions by dragging the items to the appropriate position.
1 Click Configuration on the navigation bar, and choose File > Archive Definitions.
2 Select Complete Test Definitions.
System configuration
The following sections represent the logical progression of steps for configuring the
system.
For many of the steps, you find more detailed information in the sections of Chapter 2
“System configuration”.
1 Configuration / General
User Access tab 1 Define the user name (up to 16 alphanumeric characters).
2 Define the user ID (up to six alphanumeric characters).
3 Assign the user level to the new user.
4 Define the password (up to six alphanumeric characters)
Note: ADMIN has access to all menus and functions.
User Level tab o Define the user access to the different menus and functions.
System tab 1 Define System Identifier for host communication and printouts.
2 Set the Begin of Day time. Default: 6:00.
3 Set End of Sequence, stating the time of inactivity or the absolute time (time after
which or when the system goes from Operating mode to Standby mode).
Default: 30 minutes.
4 Set Sleeping Mode after (time after which the system goes from Standby mode to
Sleeping mode).
Default: 60 minutes.
5 Set the Alert Sound Frequency, if required.
6 Select the functions External Liquid Waste and Auto Start, if applicable.
7 Integrated cassette volume check. Default : off
Barcode tab 1 Clear the Use Barcodes On Sample Cups check box if you work with non-barcoded
samples.
Make sure that Cup Present Detection remains selected.
2 If you work with barcoded samples, define the barcode pattern for the sample
barcode used in your lab.
Default: Use Barcodes On Sample Cups.
For more information on the activation factors, see “Configuration / General / ISE” on page 29.
2 Configuration / Database
Automatic Actions tab 1 Set the period during which raw data will be available for accepted results.
Default: Delete Raw Data after accepting results.
2 Set the period after which all completed and unprocessed orders will be deleted at
BOD time.
Default: Delete Orders after 1 day.
3 Set the period after which the result lines in Journal will be deleted at BOD time.
Default: Delete Journal after 1 day.
4 Select Start Order ID to turn on automatic order numbering, and define whether
the numbers should be reset at BOD.
Default: Check box selected; Order ID: 1, Increment: 1.
5 Select whether the Final Report should be printed automatically.
If no sample barcodes are used: Select Automatically Assign Rack Positions.
6 Select Reset Rack Positions at Begin of Day.
Demographics tab 1 Define whether patient and order demographics should be used.
o If Patient ID is not selected, no patient demographics information is displayed
in the Orders and Results work area.
o If Patient Demographics or Order Demographics are not selected, the relevant
entry fields in the Orders and Results work area are not displayed.
Default: Patient ID selected.
2 Select the Keep Patient Long Term box to prevent accidental deletion of patient
information.
Default: Keep Patient Long Term not selected.
3 Configuration / Lab
Sample Tubes tab 1 Define the sample tubes used in your lab. Select from the seven predefined sample
tubes or create a new sample tube by clicking New.
Enter the tube name (up to 16 alphanumeric characters), and specify the required
settings.
2 Define one sample tube as the Cup on Tube.
Sample Types 1 Define the sample types used in the lab. Select from the five predefined sample
types or create a new sample type by clicking New.
Reserve Positions tab Use Reserve Positions for the permanent rack assignment of calibrators, controls,
cleaners, diluents and ISE solutions.
5 Configuration / Processing
Report Layout tab 1 Define the header for the Final Report.
2 Click Print Sequence and define the print sequence.
Report Output tab 1 Enable the result transmission from COBAS INTEGRA 400 plus to the host for
sample results, control results and/or calibration results.
2 Enable sample type transmission from COBAS INTEGRA 400 plus to the host.
Processing Sequence tab 1 Define the pipetting sequence within each sample order (tube).
Typical examples:
o Place high priority tests at the top of the list.
o Place long tests (for example Fructosamine, ASTPL) at the top of the list.
Extra Wash Cycles 1 Load the Extra Wash Cycle Table after all test definitions have been loaded.
o Cleaner definitions (only if the selected test is entered in the extra wash cycle table)
o Archiving the Complete Test Definitions can be used to prepare a country specific test disk, for
example test names and lab unit factors.
o You can use this disk only on systems that run the identical software to the one you used when
creating it.
New Feature with SW 2.3/3.3: Profiles and Calculated Results definitions can be archived and
loaded.
The following table gives an overview of the basic configuration for some typical scenar-
ios. The subsequent sections provide more detailed information for each of the scenarios.
Value or action
Scenario 51
Scenario 1
Scenario 2
Scenario 3
Scenario 4
With host
With host
No host
No host
Configuration / General / Barcode
o Barcode Used Not required Define pattern Define pattern Define pattern Define pattern
o Sample rack configuration o Tube type rack Sample type Sample type Tube type rack. Tube type
for most rack. rack. rack,
frequently provided
used tube/ samples are
sample type. placed on
board first.
o Sample type
Otherwise
rack for rarely
use sample
used tube/
type racks.
sample type.
o Tube type Standard tube type Standard tube Standard tube Standard tube Depends on
for lab. type for lab. type for lab. type for lab. the setup of
experiment.
o Sample type No entry. Sample type Sample type Sample type No entry.
usually used usually used according to
with the above with the above barcode
tube type. tube type. information.
1. Scenario 5 applies to users working with a computer aided evaluation program (CAEV). Test requests are downloaded in batch
mode.
Sample rack configuration o If you work with one sample type and one tube type only:
O Define one tube type racks.
o If you work with more than one sample type and more than one tube type:
O Define a tube type rack for the most frequently used tube/sample type.
O Define sample type racks for the infrequently used tube/sample types.
Example:
7 mL tubes are used for serum samples (95% of all samples).
10 mL tubes are used for urine samples (5% of all samples).
Recommended system configuration:
o Tube type racks for serum.
o Sample type racks for urine.
Sample type rack Define a sample type rack for rarely used tube/sample types.
o Tube Type: Standard tube used in the lab.
o Sample Type: Sample type of samples used on this rack.
Tube type rack Define a tube type racks for the most frequently used tube/sample type.
o Tube Type: Standard tube used in the lab.
o Sample Type: No entry.
You can place a given sample type (for example plasma) on a sample type rack defined for another
sample type (for example 5 mL Sarstedt, Serum). Note that in this case no warning message is
displayed.
Sample type Sample type routinely used in the laboratory for the selected tube type.
Exceptions If only tube type racks are defined, but no sample type racks, and such racks are placed
on board, entering an order for a sample on this rack causes several dialog boxes to be
displayed:
1 Define an order.
The Identify Rack Positions dialog box is displayed, for example with the following
content:
Creating orders
The software supports data entry (similar to COBAS CORE II) after racks are placed on board: In
Orders / Sample, you can open a drop-down list to list all onboard samples without orders.
Identical to INTEGRA 700, an assignment of a sample order to a sample will not be performed in
the following situation:
o One sample order is entered and then one sample is placed on a tube type rack on the system.
o In this case, automatic assignment of a sample type to the sample is no longer carried out. This
handling prevents potential sample mismatch, there could be another sample of a different
sample type.
Use Barcode On On
Sample type Sample type routinely used in the laboratory for the selected tube type.
Exceptions If only tube type racks are defined, but no sample type racks, and such racks are placed on
board, entering an order for a sample on this rack causes several dialog boxes to be displayed:
1 Define an order.
The Identify Rack Positions dialog box is displayed, for example with the following
content:
Scenario 4: With host, barcoded sample tubes, with sample type information
Use Barcode On On
You can place a given sample type (for example plasma) on a sample type rack defined for another
sample type (for example 5 mL Sarstedt, Serum). Note that in this case no dialog box is displayed.
The sample type will be determined by the barcode and not by the rack definition.
System configuration
A
This chapter provides detailed information on configuration tasks for the COBAS
INTEGRA 400 plus.
Configuration / Processing..............................................................................................54
Configuration / Processing / Report Layout / Print Sequence ................................54
Configuration / Processing / Processing Sequence ..................................................55
Configuration / Processing / Extra Wash Cycles......................................................56
Extra Wash Cycle Table.........................................................................................57
Configuration / Definitions / Tests / Class/Group / Test Sequence...............................58
B
A
Configuration tips
o User ID and password consist of between one and six alphanumerical characters.
o The password is case-sensitive, the user ID is not.
o Default password, user level and access rights to menus can be changed on this tab
and in the User Level tab, provided you have access level 6.
Begin of Day Defaults: Check box selected, the time is set to 6:00.
Begin of Day (BOD) is the time a new work day is started. The system wakes up if in
Sleeping mode and performs the scheduled BOD service actions.
o The laboratory must analyze its workflow in order to choose the appropriate End of Sequence
time. Roche recommends setting Time or Inactivity outside the usual working period in order
to avoid the problem of having the system still in Operating mode at the defined BOD time.
This would prevent the BOD service actions from being executed, which should be avoided.
o The life span of the absorbance photometer lamp and fans decrease if the system remains in
Operating mode.
o If the instrument is in Operating mode at BOD time, the BOD service actions will not start!
The Auto Start function is implemented in the same way as in COBAS INTEGRA 800.
Barcode Scanner Barcode Scanner settings can be changed by Roche service personnel only.
o Code 128
Barcode types UPC (A, E) and EAN can additionally be defined. To avoid conflicts with different
barcodes, set the barcodes that are not needed to Not Active.
Barcode Pattern Default: six-digit order number plus twelve ignore characters (x)
The Justification (Left/Right) now works correctly. Therefore, leading or trailing ‘x’
patterns (Ignore Character) are no longer necessary for correct alignment.
See “Setting up host communication” on page 63 for additional tips on barcode definition.
Example:
o Type “0” to delete all raw data from the previous day.
o Type “1” to delete all raw data created more than 24 hours ago.
Remove all sample racks from the system, otherwise orders cannot be deleted.
Example:
o Type “0” to delete all patient orders from the previous day.
o Type “1” to delete all orders created more than 24 hours ago.
o Remove all sample racks from the system, otherwise sample rack positions cannot be cleared.
o Roche strongly recommends activating this function in order to prevent any possible confusion
in rack position assignments.
Configuration / Lab
On the Configuration Lab dialog box, you can
o Define the sample tubes used.
o Define sample types.
o Define the rack configuration.
o Assign permanent rack positions for calibrators, controls and diluents.
COBAS INTEGRA 400 plus users should consult their Roche Representative for assistance if they
intend to change the proposed tube settings, or if they use a tube type that is not listed in the
Defined Sample Tubes list.
The sample tubes that are predefined by Roche are displayed in blue and cannot be
deleted. The Tube Length and the Outside and Nominal Diameters cannot be changed
for any Roche sample tubes.
The following table gives an overview of all predefined Roche sample tubes.
Trigger Point 75 73 85 70 88 85 95
Diameter Outside 12 12 13 15 15 13 16
Level Detection Sensitivity High High Middle Middle Middle Middle Low
Grid C C B E B A A
o The grid settings of the selected tube may change if Use Cup on Tube is selected. See
“Defining additional tubes” on page 33 for more detailed information..
Additional types of tubes and cups can be used on the system. They must be defined
here. The permission to modify or add tube types depends on the user access level.
1 Click New.
The fields are cleared to allow a new tube type to be defined.
2 Enter the Tube Name of the sample tube to be defined.
3 Enter the Tube Length of the sample tube in the range of 20 mm to 108 mm.
The tube length defines the position of the sample rack grid device. See the
following table:
Grid Position A B C D E F G
See also the table in section “Defining tube types” on page 32.
The grid position of the selected tube type may change if Cup on Tube is selected.
This check box does not restrict you to use only the tube with the cup. It only enables the use of the
cup on that specific tube. You have to select the appropriate check box (in the Orders work area)
when creating the order! So it is possible on one rack to have tubes with a cup and tubes without a
cup.
1 Click Cup on Tube at the bottom of the Sample Tubes tab. The following dialog
box is displayed:
By default, the Hitachi standard cup (catalog number 039 42 46) is selected here.
2 Define the Cup Length.
Enter the cup's tube length in the range of 20 mm to 108 mm.
3 Define the Trigger Point.
The Trigger Point indicates the height where level detection is activated. This
measurement is made from the bottom of the cup. The input range is 1 mm to
<Tube Length> in mm.
If the sample level in a tube is above the Trigger Point, the liquid level cannot be
detected. Consequently, the sample probe will move down to the defined Lower
Sample or Tube Margin and the following error message is displayed: “No fluid
detected: slot x position y”.
4 Define the Lower Sample Margin.
The Lower Sample Margin indicates the maximum distance the sample probe can
travel for samples. This measurement is made from the bottom of the cup. The
Lower Sample Margin must be specified in the range of 1 mm to <Trigger Point -
1 mm>.
5 Define the Lower Cup Margin.
The Lower Cup Margin indicates the maximum distance the sample probe can
travel for calibrators, controls and diluents. This measurement is made from the
bottom of the cup. The Lower Cup Margin must be specified in the range of 1 mm
to <Trigger Point - 1 mm> and be less than the Lower Sample Margin.
6 Define the Cup Diameter Outside.
Enter the outer diameter (mm) of the sample cup in the range of 9 mm to 18 mm.
7 Define Cup Diameter Nominal.
Enter the inner diameter (mm) of the sample cup.
The value must be in the range of 5 mm to < Diameter Outside - 1 mm>.
Recommended cups
o The Hitachi Standard cup or Microcup cannot be used on 10 mL primary tubes with a length of
100 mm, the cup collar is too large. In this case Roche recommends using alternative cups, for
example the T-Cup.
o Do not use COBAS Cups on tubes. Always use the aluminum cup adapter for this purpose.
Checking the lower sample o Fill the check sample solution to below the defined Lower Margin and order
and tube margin <CHKCS> twice.
The probe should not touch the bottom of the sample tube or cup and the
following error message should be displayed: “No fluid detected: slot x position y”.
Checking the level 1 Fill the check sample solution to above the defined Lower Margin and below the
detection sensitivity defined Trigger Point. Order <CHKCS> at least 30 times.
The error message “No fluid detected: slot x position y” should not be displayed,
and no outlier should occur.
2 Check if the accuracy and precision of <CHKCS> are within the ranges specified.
If necessary recheck with the next step of level detection sensitivity (one step up or
down depending on sample tube dimensions).
Checking the trigger point o Fill the check sample solution to above the defined Trigger Point and order
<CHKCS> twice.
The following error message should be displayed: “No fluid detected: slot x
position y”.
The probe should move down to the Lower Sample or Tube Margin, but it should
not touch the bottom of the sample tube or cup.
A sample cup or tube may only be modified or deleted when the cups have not been assigned to
sample racks in the Rack Coding Set Up menu (S31). Once assigned, the sample cup information is
highlighted and cannot be modified or deleted.
In order to change the grid position on COBAS CORE II, modify the tube length of
COBAS Cups and Eppendorf cups as follows:
1 Access the Sample Cup Definition menu:
a. Press F8 [SYSTEM].
b. Select <3> Customization.
c. Select <2> Sample Cup Definition.
The following screen is displayed:
2 Press [F1] (Modify) and move to the field using the [↓] and [↑] key.
3 Make the following changes for COBAS Cups and Eppendorf cups by typing in the
new information or by making a different selection in the status line.
Sample Types can only be added or modified if all results have been accepted or transmitted, and
the samples of this sample type are not on board.
Defining racks
Prerequisites o The ability to modify or add sample racks depends on the user access level.
o A rack can only be deleted or modified if it is not on board.
a To define a rack
The ISE Rack is labeled ISE on the front tab of the rack.
3 Enter the rack number in the range of 1 to 999, for example 140.
4 Enter the rack barcode in the range of 1 to 999, for example 140.
Rack codes must be unique.
The Rack Code is the barcode identification number of the rack used to identify
the ISE rack.
5 Select the Barcode box to ensure that the barcode labels on the bottles on the ISE
Rack are read. By default this box is not checked.
Add inserts a new line, allowing you to enter the Rack Number and the Rack Code
of the new cassette rack.
3 Enter the cassette rack number in the range of 1 to 999.
The Rack Number is the label number on the front tab of the rack.
4 Enter the rack barcode in the range of 1 to 999.
The Rack Code is the barcode identification number of the rack used to identify
the cassette rack. It must be unique.
o Only one type of sample tube or sample cup can be used on each sample rack.
o Do not mix different tube types on the same sample rack!
The fields are cleared, allowing you to define a new sample rack type. The cursor is
positioned in the Rack Name input field.
2 Enter the Rack Name.
The name can have up to 10 alphanumeric characters and must be unique. No
special characters like +, -, /, * are allowed.
3 Select a Tube Type from the list of defined sample tubes (see Configuration / Lab /
Sample Tubes).
4 Define the sample type.
o Keep the Sample Type field blank to define the sample rack as a Tube Type
specific rack.
o Select a sample type from the list of defined sample types (see Configuration /
Lab / Sample Types) to define the sample rack as a Sample Type specific rack.
This sample type can only be used on this rack without confirmation.
For more information on when to define a sample type rack, see “Scenario 2: No
host, barcoded sample tubes, no sample type information” on page 18 and
“Scenario 3: With host, barcoded sample tubes, no sample type information” on
page 20.
5 The Grid is automatically assigned, based on the tube length of the selected tube
type. The grid position cannot be changed manually.
6 Once the sample rack is defined, select the sample rack on the Defined Racks list.
7 Click Add.
A new line is inserted, allowing you to enter the Rack Number and Rack Code of
the new sample rack.
The “empty position barcode” at the back and front of the racks is always read, regardless of the
Barcode setting.
Rack Name The rack name could describe the rack function.
Examples:
o COBAS: Sample rack specific for COBAS Cups.
o VACU7mL: Sample rack specific for 7 mL primary tubes.
o CALQC: Sample rack specific for calibrators and controls.
o URINE: Sample rack specific for urine samples.
Rack Number The Rack Number should correspond to the Rack Code, for example if the sample rack
number is 1, then the recommended sample rack barcode is 001. If the cassette rack
number is 1, then the recommended cassette rack barcode is 101.
Rack Code Roche recommends using one set of rack barcode numbers for sample racks and a
different set of rack barcodes for cassette racks.
Example:
o Rack barcodes 001 - 100 for sample racks.
o Rack barcodes 101 - 200 for cassette racks.
Tube/Sample Type Rack A meaningful configuration of sample type or tube type specific racks depends mainly
on whether sample barcodes and connection to host are used or not. Some typical
approaches are described in “Typical configuration scenarios” on page 15. Refer to the
scenario that reflects your laboratory setup.
1 Select a rack from the Rack list. Selecting a rack will display its current position on
the right.
Calibrators, controls, cleaners, diluents and ISE solutions are listed in folders on
the left.
2 Open a folder and drag and drop an item onto the rack.
Multiple positioning is possible for diluents and cleaners. Consequently, these two
folders are always displayed on the left.
The ISE solutions have recommended positions on the ISE Rack:
1 SDR 2 Yes No
7 9% NaCl No Yes
Auxiliary diluents
Volume management is performed with all diluents. This software calculation mode is
based on volume information and calculates the correct immersion depth of the
sample probe if a new bottle is placed on a specific position of the ISE rack. It delivers
information in percent about the filling status of bottles.
9% NaCl can only be used in the ready to use 25ml NaCl bottles placed on the ISE-
rack. It is not possible anymore to use 9% NaCl in a 10ml bottle and placed on the ISE-
rack
If the option Repeat is selected, the box End Action automatically is displayed. Here it
is possible to define a second action (End Action) For example, a flagged result can be
accepted as the end action if as a result of the first action the test was rerun and the flag
still appears.
Calibration tab
No Flag Normally the first action for No Flag is Accept. If the customer wishes to manually
validate and accept calibration results, define this as None.
Any Flag If Any Flag is generated for any calibration result, the action defined here will be
performed. It is not flag specific.
o If None is defined, the system will continue to process patient samples following a
flagged calibration, and these results will also be flagged.
With ISE tests, the test is blocked in the same way as with the Stop Test action.
o If Stop Test is defined, the test will be disabled and no further patient samples will
be processed.
o Reactivation of tests is done in Status / Test Status: Check the Test Enabled check box.
o Reactivation is also performed after a repeated calibration has been accepted.
No Flag Normally the first action for No Flag is Accept. If the customer wishes to validate and
accept quality control results manually, define this as None.
Any Flag If any flag other than a QC specific flag is generated for a quality control result, the
defined First Action is performed. This is not flag-specific.
If None is defined, the system will continue to process patient samples following a
flagged quality control result, and these results will also be flagged.
QC-specific flags Here, the different First Actions for specific QC flags can be defined individually.
The actions defined for Any Flag take priority over those defined for QC-Specific flags.
o If Repeat is defined, the quality control order will be repeated. The order will be
repeated As Original.
o If Stop Test is defined, the test will be disabled and no further patient samples will
be processed.
o Reactivation of tests is done in Status / Test Status: Check the Test Enabled check box.
o Reactivation is also performed after a repeated control has been accepted.
o If None is defined, the system will continue to process patient samples following a
flagged quality control result, and these results will also be flagged.
Samples tab
All sample-related flags are listed on this tab, as well as the No Flag option. There are
three possibilities for handling unflagged or flagged samples:
o None
o Accept
o Repeat.
As before, the First Action for No Flag is normally Accept, unless the customer wishes
to validate and accept unflagged patient results manually.
For flags where the First Action Repeat is defined, the next action will depend on the
test definitions.
For each flag, a description of the flag and a recommended action is displayed at the
bottom of the dialog box. This information is also given in Orders / Quality Control.
The actions that need to be taken when a certain flag appears can be defined according
to the customers needs.
For quality control and samples, it is possible to define Repeat for the No Flag category. Do not
select this option! If you do, all samples will be repeated, irrespective of whether they are flagged
or not.
If a calculated result was calculated using a flagged test result, that corresponding test
will automatically be rerun according to the result handling settings for samples and
the postactions defined for the individual test.
Except for calculated results, result handling can be defined according to the test class (including
user defined test classes). This allows different First and End Actions to be used for different tests
according to the customers requirements.
Result handling on COBAS INTEGRA 400 vs. COBAS INTEGRA 700 and 800
Automatic handling of flagged results on COBAS INTEGRA 400 differs in some details
from result handling on COBAS INTEGRA 700 and 800.
When configuring the Result Handling Table on COBAS INTEGRA 400, be aware of
these differences in order to avoid unexpected behavior.
On COBAS INTEGRA 700, all flag handling is defined in the Result Handling Table.
The test-specific Result Handling Table takes priority over the main Result Handling
Table. On COBAS INTEGRA 400, some flags are already predefined with automatic
postactions as part of the Test Definitions. As on COBAS INTEGRA 700, test
definitions cannot be modified by the user, neither can the predefined postactions.
The predefined flags and their default postactions are listed in the following table:
AG Excess2 Postdilution
These flags also appear in the Result Handling Table, but the predefined postactions in
the Test Definitions take priority over whatever is defined in the Result Handling
Table.
The sequence of events for result handling on COBAS INTEGRA 400 is as follows:
If a result is flagged, the software first checks if the flag is one of those defined in the
test definitions (Configuration / Tests / Dilutions):
1. If the flag is one of those defined with a default postaction, and Autodilution is set
to Sequential, the defined postaction is performed.
If more than one postaction is defined, the system will follow the sequential
dilution (or concentration) steps if the first rerun result is still flagged with the
same flag.
2. If the result is still flagged after performing all the defined dilution (or
concentration) steps, or if another flag is generated, the system refers to the Result
Handling Table in order to determine the next action.
3. If the Autodilution is set to Off, no postactions with dilutions will be performed
for any flagged results for the test.
For the predefined flags shown in the table above, Roche recommends configuring the
Result Handling Table as None.
Remember, however, that None in the Result Handling Table will not disable, for
example automatic postdilution for results flagged >Test Range. In order to disable
automatic actions for the predefined flags, set Autodilution to Off (Configuration /
Tests / Dilutions). Simply defining None in the Result Handling Table still allows
predefined postactions to be performed.
Configuration / Processing
As tests are loaded, the print sequence is sorted in alphabetical order within the
unassigned test group.
Calculated Results (Ratios) are included in the print sequence list.
The Processing Sequence defines the pipetting sequence within each sample order
(tube).
Typical examples:
o Move high priority tests to the top of the list.
o Move long tests (for example Fructosamine, ASTPL) to the top of the list.
The setting of the processing sequence does not significantly influence test
throughput.
Each time tests are loaded, they are added to the bottom of the list.
2 Click Load to load the actual Extra Wash Cycle (EWC) table.
3 Specify the path from where the wash cycles should be loaded. Default: C:/Roche/
Instrument/TAS.
4 Select the Extra Wash Cycle file.
5 Once the Extra Wash Cycle (EWC) table is loaded, you can switch off an Extra
Wash Cycle by clearing the Active check box, provided the test/reagent
combination is not in use on the system.
6 Click Add to define an additional EWC.
7 Define the type, affected test, component, cleaner, and cleaner volume.
The actual Extra Wash Cycle (EWC) settings are shown in “Configuration /
Definitions / Tests / Class/Group / Test Sequence” on page 57.
Whenever new tests are added to the current test list, the Extra Wash Cycle is automatically
loaded.
Roche strongly recommends that you do not change the predefined Extra Wash Cycle (EWC)
settings.
The test sequence affects only the display of test buttons on the Sample, Calibration,
and Quality Control tabs of the Orders work area.
By default, the tests are listed alphabetically.
Selecting Custom activates the Move Up and Move Down buttons.
This chapter provides information on setting up the COBAS INTEGRA 400 plus data
station and host communication.
C
A
Number
1 Type into the Decimal Symbol text box a period (full stop) “.” .
2 Make sure that the Digit grouping symbol is different from the Decimal symbol.
Date
The Short date style usually defines the data entry format. The recommended style is
dd/MM/yyyy. Four digits are necessary for the year, otherwise each date of birth >1950
entered in Patient demographics will be rounded to 2000, and the following error
message is displayed: “Date not valid: The date of birth entered for the patient is in the
future”.
The recommended Long date style is dd/MMM/yyyy. For the year, four digits are
necessary. For the day and month, any format can be selected. If the format MMMM is
selected for the month, some screens will not display the full date.
The installation will be done automatically in case you use plug & play printer
7 Press Start / Printers and Faxes and check the printer stuts if ready.
8 Select the printer and press the right mouse button Properties
9 In the General folder press Print test page.
10 Click Shut down and restart within the window Logon information.
11 Log on as cobasoperator
Do not connect the printer cable to the data station until prompted to do so. Attaching the printer
to the PC before starting the software installation, may cause errors during the printer setup
process.
1 Make sure the instrument, the data station and the printer are powered off and the
printer cable is not connected to the computer.
2 Prepare the printer in accordance with the manufacturer's recommendations.
3 Start the data station and log on as cobasinstall
4 Place the software CD-ROM that came with the printer into the computer DVD-
ROM. If the New Hardware Found message appears on the screen, click Cancel.
Usually a Welcome screen does automatically open, if not select Start, then Run
from the Windowsdesktop and browse to your CD drive, select the setup and click
OK.
5 Follow the instruction on the screen.
1 Prepare an interface cable and connect the cable to the host and to the data station.
2 Enable host interface transmission: results and sample type (according to the host
computer's settings) (Configuration / Processing / Result Output).
3 Define interface parameters as needed (Configuration / General / Interface).
4 Prepare the database setup (Configuration / Database / Demographics).
5 If you are using barcodes, setup the instrument accordingly.
6 Load your host application. As a first check send an idle block.
1 Connect the COM serial port to the COM-B port of the data station.
COM4 is a Sub-D male type 9-pin connector.
2 Connect the DS connector of the data station to the DS connector of the data
station.
Switch off all the result type transmissions which are not needed for the LIS computer. This
influences the automatic deletion of the corresponding raw data.
Sample Type Selected Sample type for order identification (Order ID, line code
53) and tube information (line code 42) is sent from
COBAS INTEGRA 400 plus to the host.
For example, patient results will be sent to the host,
including sample type information.
Sample Type Not Selected No sample type information will be transmitted via the
HIF.
If the sample type for an order is not sent from the host to the COBAS INTEGRA 400 plus, COBAS
INTEGRA 400 plus will automatically supply the test’s default sample type.
In this case, the test’s default sample type must be identical either to the sample type of the rack
holding the sample or the sample type encoded in the sample barcode.
If this is not the case, a new patient order with the test’s default sample type is generated on
COBAS INTEGRA 400 plus with the status Not on Board. The sample on board has the status
Sample without Orders, because it has not received an order, and so no processing will take place.
This behavior is different from that of the COBAS INTEGRA 700.
Data Bits 7, 8
Stop Bits 1, 2
All interface parameters have to be set to the same value on the host and on COBAS INTEGRA 400
plus.
Free Text Fields Selected The instrument allows defining laboratory specific fields.
The fields and their assigned names are shown in the
patient or order menu. Send the relevant information via
the host interface.
Not selected The free text fields will not be shown in the patient or
order menu. On the host interface, you may leave empty
the relevant fields in the Patient and Order Entry blocks.
The Sample Type Short Name is used in the Host Interface Protocol (HIF) if the
sample type is enabled in Configuration / Processing / Result Output.
If you use barcodes without sample types, Roche recommends using sample-type specific racks.
Barcode setup
To enable barcode reading use Configuration / General / Barcode.
The barcode must not be shorter than the pattern you specified.
Example:
Barcode pattern
12-UR-PL3456 00xTTx00 12-UR-PL3456
By setting Counts and Time to zero, this service action will never become due.
4 Select the BOD box of those actions that should be performed at BOD.
The following service actions are set by default as BOD actions:
o Backup Database
o Initialize ISE module
o Electrode service
o Prime ISE calibrators
o Clean ISE tower automatically
o Deproteinize Probes
o Prime Fluid Systems
All other service actions must be individually defined as BOD actions.
Since the SW 3.4 we have implemented from the diagnostivs the new service action ISE
Performance Check. This service action is very usful for troubleshooting.
Recommendations
Use the default settings for all Service Action intervals, except for the following
actions:
1. Electrode Service:
Counts and Time define the number of tests or the time interval at the end of which the
service action Electrode Service will become due. The default counter is set to 4500 tests.
Because electrode contamination depends on the ISE pipetting mode, different factors for
each ISE pipetting mode are defined in the software (not accessible for users):
ISE direct mode: 5
ISE urine mode: 7
ISE indirect mode: 10
Example: The service action Electrode Service is due once 450 ISE indirect samples were
measured.
This default setting of 4500 counts is sufficient for almost all customers. If more than 500
samples per day are measured, change the setting to 2500 counts.
2. Activate Electrode:
The default counter is set to 50 tests.
If more than 50 ISE urine samples per day are measured, reduce Counter Total to 30 (tests).
This counter can only be changed in Configuration / General / ISE: Set the value Counter
Total to 30.
If you follow the This recommendation includes one Roche service visit every 180 days or every 150,000
recommended Roche tests.
Preventive Service Concept The following listed service actions are part of the Roche service visit. To avoid undue
concern on the part of the customers, these actions should not become due, and
therefore the Counts and Time should be set to zero.
Hardware overview
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Lesson
Lesson
Product specifications
Reagent cassette identification o Automatic barcode reading. Each cassette is uniquely coded.
Sample loading capacity o Up to 90 primary or secondary tubes (six racks of 15 sample tubes).
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Lesson
Calibration stability o Typically each lot for enzymes, substrates or serum proteins.
o 20-26 weeks for TDMs.
o 3-6 weeks for DATs.
Hardware overview
At the analyzer, with the main cover open, shows the following, starting from
the left to the right:
ISE module
o Potentiometry.
o ISE - tower.
o Faraday cage containing electrodes (sequence: Li, K, Cl, Na).
o Peristaltic pump.
o ISE reference solution.
o ISE calibrators: Direct and Indirect/Urine.
o Method: Direct, Indirect and Urine mode.
o Measuring cycle: 53 seconds.
o Main calibration: every 5 hours.
o 1 point recalibration: every sample measurement.
Fluid system
Internal water reservoir o One liter capacity with level sensor, removable for cleaning.
Pump module A o The pump brings water into the internal reservoir and a waste pump
aspirates liquid from the wash station and ISE module.
Water requirements o Laboratory Reagent Grade, type I NCCLS, bidistilled or deionized water.
Minimum conductivity: > 0.6 MW/cm.
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Fluid waste disposal o Via direct connection to sanitary sewer system or to the supplied external
waste container.
Wash pipette B and C o Two 5 mL glass syringes, one for each probe are used to clean the probes in
the wash station after every pipetting action with water and cleaner.
Dosage pipette B and C o Two 250 µL glass syringes are used to pipette reagents and samples.
Valves o Control the water and cleaner to the wash syringes and to the pipetting
syringes.
Probes o The B and C probes relate to the corresponding pipetting area on the
workstation.
If the temperatur range of 15°C exceed, the tempature icon turns yellow as well as
the backgrund information in the analyzer tab shows for example Casserre: 16.3°C.
The instrument creates e errormessage and the message icon change to yellow.
Rack status indicator o The rack status panel contains a set of small lights (LEDs-light-emitting
diodes) that show the status of the rack immediately below the light.
o The logo on each light indicates the type of rack (cassette, sample, or ISE).
The color and whether the light is blinking or steady tells you more about
the status of the rack.
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Lesson
o After a rack has been inserted, the LED signal indicates the type and the
status of the rack.
No light o There is no rack in the slot. You can insert a rack into the rack
platform.
Green light steady o The rack has been inserted correctly You can remove the rack from the rack
and is ready to be processed or… platform.
o The processing of the rack is
completed.
Green light blinking o The rack is being loaded and rack You can still remove the rack from the
identification is taking place or… platform.
o The rack is being removed.
Red light steady o The rack is locked because it is being You cannot remove the rack while the red
processed. Pipetting is in process or light is displayed.
about to begin.
Red light blinking o The rack cannot be identified Remove the rack and define it in
because it is not defined on the Configuration / Lab / Racks.
system or...
Check the barcode label for damage
o The barcode scanner could not read
the barcode label.
Orange light blinking o The rack has not been properly Remove and reinsert the rack. If blinking
inserted or... reoccurs, check the messages for the
reason.
o The barcodes were not recognized
or...
o Another rack on board has the same
code.
Unlock rack tool The unlock rack tool is supplied with the instrument. It is located on the right
of the cleaner reservoir. You can use it to:
o Pierce the aluminum foil seals of cassette vials that require reconstituting.
o Remove the rack platforms for cleaning.
o Manually release racks.
o Open the controller rack
o When the instrument is not in operation, you can release racks manually
by using the unlock rack tool to press the release button.
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o Vial A (max. 25.0 mL) is located in the middle with vials B and C
(max.12.5 mL) on either side.
o Vial C is the one nearest to you (barcode on the right side) when a cassette
is inserted.
o The vials are closed with screw caps (liquid reagents) or screw caps with
aluminium foil (granulated or lyophilized reagents).
o For clear identification of the vial position, the bottom of the cassette is
engraved with A, B, and C.
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Lesson
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Lesson
Cassette Barcode o The barcode identifies the test (article number), lot number, expiry date,
ICVC and cassette number.
Preparation o Most of the cassettes are liquid reagents and can be placed directly onto the
cassette rack and onto the system.
o The barcodes are read automatically and the caps are pierced by the probe
when the cassette is needed.
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Lesson
On the COBAS INTEGRA 400 plus, the aluminium foil on the bottle containing
granulate or lyophilized reagents has to be pierced using the tip of the unlock rack
Cassette rack o The cassette rack can hold up to four reagent cassettes.
o Each rack is identified by a number on the front tab of the rack and a
barcode identification label on the side.
o The barcode laser scanner automatically reads the cassette ID, as a rack is
placed onto the system.
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Rack number o Each rack is identified by a number on the front tab of the rack.
Tube types and cups o The system can use both primary and secondary tubes for samples,
calibrators and controls.
o The following types of tubes are predefined:
O COBAS cup (Bio cup)
O Eppendorf cup
O Sarstedt 5 mL
O Sarstedt 5.5 mL
O Sarstedt 7.5 mL
O Vacutainer 7 mL
O Vacutainer 10 mL
o COBAS cups and Eppendorf can be used when placed in an adapter.
Tube height adapter (grid) o Used to correctly position the tubes and the cups in the rack.
ISE rack o The ISE rack has preassigned positions for some of the solutions used with
the ISE module.
o There are also two free positions, which typically are assigned to diluents
or cleaners. You can assign these positions in Configuration / Lab / Reserve
Positions.
o Slot O on the sample rack platform is reserved for the ISE rack.
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Lesson
o The barcode scanner reads across the rack area, so only insert one rack at a
time.
o When inserting a rack, the rack is first stopped to allow the laser to focus on the
correct rack slot and rack barcode.
o The lock is then released allowing the rack to be inserted completely. Insert the
rack in one smooth motion - stopping and then continuing may interrupt the
barcode reading and result in having to remove and reinsert the rack (flashing
orange LED).
o When removing a rack - remove it completely from the system - do not leave it
partially in the slot as this will prevent the insertion and reading of another rack.
Transfer arm
o Movements in the X, Y, Z directions.
o Reagent, Sample- and SR-probes.
o Front probe: B (reagents, diluent and samples).
o Back probe: C (reagents, diluent and samples).
o The transfer arm accesses the ISE module, the cassette, sample, QC, Cal
racks, the wash stations, and workstations B and C. It is a single arm
containing valves and motors and 2 pipetting probes. It operates in three
dimensions (X, Y, Z directions).
Initialization posts
o The initialization posts are fixed surfaces that the instrument uses as
transfer reference points during initialization. There are four initialization
posts:
O ISE module
O Cassette area
O Sample area
O Wash station
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Analyzer module
The system will check every day during BOD and while the system goes from
sleeping mode into the operating mode if the analyzer ciculation fan is running. If
not it would lead to a fatal error and the instrument stops.
Workstations B and C o Remove cuvettes from the analyzer rotor to add reagents, diluent or
samples, mix with an elliptical rotation and replace the cuvettes back onto
rotor.
Workstation FP o Removes a single cuvette from the rotor so that fluorescence polarization
measurements can be made in the FP photometer. When the
measurements are complete, the workstation returns the cuvette to the
rotor.
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Lesson
Cuvette reservoir capacity o 1400 disposable cuvettes, refilling possible during operation.
Fluid waste from the ISE module goes directly to the cuvette waste box and is not
registered by the system. If you run a lot of ISE measurements check the waste
container regularly.
Computer system
External Data-station:
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Exercises
Exercises
A J
B K
L
M
C N
O
E
P
Q
F
R
G
H
S
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G
B
H
C I
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Exercises
A D
A
B D
B C
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…… Rack number
…… Vials for reagents and start reagents
…… Rack barcode
…… Barcode for confirming a missing cassette from this position
…… Cassette (removed)
…… Press this button for manual release of the rack with Unlock rack
tool.
D
A
B E
C
F
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Sample rack
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D E
A
B
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…… Splash guard
…… Sample loop holder
…… Transfer head cover
(removed)
…… Probe C
…… Probe B
B E
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…… Workstation FP
…… Workstation B
…… Workstation C
…… Workstation In/Out
…… FP photometer
…… Cuvette buffer and slide (cuvette transport system)
…… Rotor cover
…… Absorbance photometer
A
E
B
F
C
G
H
D
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…… Electrode block
…… ISE tower
…… ISE Calibrator Indirect/Urine
…… ISE module tubing
…… Peristaltic pump
…… ISE Calibrator Direct
…… Distribution block
…… Reference Electrolyte
A
D
B
E
C
F
G
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Exercises
A ISE Deproteinizer
B ISE Etcher
Rackcode 014
2
3
4
C Special diluents
5
6
7
8
D ISE Activator
E ISE solution 1, 2, 3
IS
E
14
C
O
B
A
S
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Exercises
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Test run
In this chapter, you will get your first practical experience, doing interactive
exercises:
o Read and leave a message for the other operators.
o Access the Status work area.
o Create orders for patient samples.
o Print a worklist.
o Load samples on board.
o Check for missing materials.
o Load reagent racks.
o Process patient samples.
o Access Help.
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Lesson
Lesson
This lesson consists of practical exercises.
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Exercises
Exercises
a To log on
Before you log on the system, the main screen displays only the accessible
icons.
The Memo Pad, the Status and the Messages icons are active, the other icons
remain inaccessible.
1 In the menu bar, select Tools, Log on/off or press Shift F3 on your
keyboard, or double-click NONE in the operator box (bottom of the
screen)
2 Type in your Operator ID and Password (previously defined in
Configuration / System / General / User Access).
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4 Click the Order ID drop-down list. All samples that are present on the
instrument are displayed in the Without Orders folder.
5 Using the table below, chose the first Order ID, then define its
corresponding Patient ID and name, and select the tests. Then click Save.
Use the same procedure to create orders for the other patients.
6 On the menu bar, choose File > Print Report > Worklist. Click Print.
7 Describe the information on the worklist:
.......................................................................................................................
8 The trainer will provide you with the reagent racks ready to load.
9 Check if all reagents are available.
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5 On the menu bar, choose File > Print Report > Missing and Blocked.
6 Click Print.
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B F
G
C
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Exercises
Yellow o Reconstituting
o Req. Mixing
o Near Expiration or Expired
o Not enough for worklist
o Cal. Expired
Red o Empty
o Unknown fluid
o Definition not loaded.
o ICVC not ok
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Gray Ready
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17 Find out why your tests are blocked and list the reasons:
..........................................................................................................................
..........................................................................................................................
..........................................................................................................................
18 Perform the appropriate actions and provide the requested resources.
o Clear the Test Enabled check box to disable a test. Calibrations and controls can
be run on disabled tests, but samples cannot.
o You can disable a control temporarily here, but you must re-enable it here also.
o Use the check box to the right of each control to enable or disable it.
o If you see a status Diluent not on board, and you replace the diluent while the
system is in Standby, the status display is not updated until the system is in
Running.
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Exercises
20 Explain this screen by describing the functions of the different items in the
different color states.
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21 Perform the appropriate actions to get the system in Running status.
Analyzer tab the analyzer, cleaner and cassette aere are temperture checked. If the
temperature of the analyzer and cleaner are not within the required limits, the
system stops.
The icon on the Status button changes depending on the system status.
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Exercises
Resource icons o The Cleaner icon shows the status of the cleaner
fluid bottle.
o The Cuvettes icon shows the status of the
cuvettes reservoir.
o The Water icon shows the status of the water
supply.
o The Cuvette Waste icon shows the status of the
cuvette waste box.
o The Waste Drain icon shows the status of the
waste drain or reservoir.
The ISE tab represents the ISE solution rack, the solutions and the
electrode block.
23 Make sure that your ISE module is enabled by clicking the Enable ISE
Module box.
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Exercises
o If you do not have an ISE module, you must still place bottles of deproteinizer
and activator on the ISE rack. You can use the other positions for diluents.
o The positions of the ISE solutions on the ISE rack are not fixed.
o These positions are defined using Configuration / Lab / Reserve Positions.
o All ISE solutions on the ISE rack should have caps except for the activator,
SDRII, Accelerator.
25 Check the color coding on the ISE solutions and replace the empty bottles.
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Exercises
a To view messages
1 Click the Messages icon on the application bar, or choose Window >
Messages on the menu bar, or press Shift F5 on your keyboard.
The background color of the Messages button shown on the navigation bar
indicates whether there are messages waiting to be viewed. The
background color also indicates the severity of the message.
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Exercises
E
A
F
B
C
D
H
5 Click Close.
6 Select the problem and click Confirm.
7 What happens to your message?
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Exercises
o Click Confirm to inform the system that you have fixed the problem in the
message.
o If you have not fixed the problem, the system will either not restart, or the same
message will reappear again, if the same conditions are met.
o Confirmed messages are automatically transferred to the Message Log.
A E
B
C
D
G
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Exercises
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Exercises
14 A dialog box appears "Do you want to add a DB export to......" Click YES
15 Insert a floppy disk. Eventually more than one floppy disk will be required.
16 A dialog box appears”....copy to floppy disk....” click YES
You have now the problem report and the database export compressed to
one file on the floppy disk(s).
o If you have a Integra 400 plus with SW 3.3 Evo 510 you can also use the USB
stick instead of floppy disc.
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.
Step 5 — Checking the Memo Pad for messages
1 Click the Memo Pad icon on the navigation bar, or choose Window >
Memo Pad in the menu bar, or press Shift F7 on your keyboard.
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Exercises
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Exercises
a To access Help
General information If an error occurs, the specific help text will be displayed by double-clicking
on the selected error message. In software version 2.0, the help text was only
available in English. For the software version 2.x, the help text can also be
displayed in other languages as well.
A direct link between the hardware error message and the corresponding help
text (if help information exists) will be provided. (In the software version 2.0 a
search via help table was necessary.)
In software version 2.x, the full help option will be available in the selected
language, which is set in Configuration / General / System / Language tab.
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Exercises
Roche Diagnostics
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Configuration
Roche Diagnostics
Training Manual · Version 1.3 4-1
Configuration COBAS INTEGRA 400 plus
Roche Diagnostics
4-2 Training Manual · Version 1.3
COBAS INTEGRA 400 plus Configuration
Lesson
Lesson
To be completed.
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Training Manual · Version 1.3 4-3
Configuration COBAS INTEGRA 400 plus
Exercises
Exercises
Exercise: Definitions
1 In the Definitions area, double-click the Controls icon or choose View >
Definitions > Controls on the menu bar.
The Configuration Control Definitions dialog box is displayed.
2 Click Load.
The Load button is used to install Roche controls from the harddisk.
The New Control button is used to install non Roche controls.
The name of the directory, where all the control definitions are loaded, is
displayed per default,
3 Click OK.
The Load Control Definitions dialog box is displayed.
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Exercises
The newly installed controls are now in the list of controls in the
Configuration Control Definitions dialog box.
4 Click OK.
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Training Manual · Version 1.3 4-5
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Exercises
The Load Complete Test Definitions dialog box is displayed, showing the
test names.
5 Select Keep Old Lab Settings, if you want to keep user defined test settings.
6 Select the following tests:
ALTL, CKL, CKMBL, TP, ISE-D, IGA, THEO.
7 Click Load.
The Load Definitions in Progress dialog box is displayed.
8 When finished, press Cancel to exit the Load Complete Test Definitions
dialog box or press Alt+F4 or ESC.
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Exercises
The newly installed tests will appear in the Installed Tests list in
Configuration / Test Definitions.
o The progress of loading the test is indicated in the Load Definitions in Progress
dialog box. Do not press Cancel before the action is completed.
o Test Number:
Used to communicate with the Host computer.
Can be modified.
Must be unique for all tests, profiles, and calculated results.
o Short Name:
Consists of up to 8 alphanumeric characters.
Capital letters only.
Must be unique for all tests, profiles, and calculated results.
a To install tests
1 In the Definitions area, double-click the Tests icon or choose View >
Definitions > Tests on the menu bar.
2 Select ALTL in the Installed Test list.
The ID tab gives you all the information about the test and allows you to
change the short and long names and the test number.
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Training Manual · Version 1.3 4-7
Configuration COBAS INTEGRA 400 plus
Exercises
The COBAS INTEGRA 400 plus system is delivered with predefined calibration
intervals for each test. The calibration intervals are carefully defined to guarantee
reagent performance within the set on-board stability of reagents.
Roche does not recommend to change these default calibration intervals.
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Exercises
AG Excess Postdilution
Even if the Result Handling Table is off, when a sample result is greater
than Test Range, then the programmed dilution will automatically be
performed.
When a sample result is less than Test Range, the programmed
concentration will be performed (only for spec. proteins with predilution).
9 Click Save.
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Exercises
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Exercises
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Exercises
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Exercises
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Exercises
4 Confirm with OK
5 Enter assigned values for THEO and CFAS-CKMB calibrator manually.
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Training Manual · Version 1.3 4-15
Configuration COBAS INTEGRA 400 plus
Exercises
o When using the barcode reader, Caps Lock must be switched off.
o Concentration displays up to 6 Std values 1-6 and is independent from the
calibrator used.
C.F.A.S.: 2 Std values
C.F.A.S.-CKMB: 2 Std values
THEO: 6 Std values
SERTS: 1 Std value
o Enter the concentration always from the highest to the lowest.
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Exercises
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Training Manual · Version 1.3 4-17
Configuration COBAS INTEGRA 400 plus
Exercises
1 In the Definitions area, double-click the Profiles icon or choose View >
Definitions > Profiles on the menu bar.
2 Click New, then:
a. Type the profile name: CARDIAC (maximum 8 alphanumeric
characters).
b. Type the profile number: 910 (must be 3 digits).
c. Type the test number: 910-930 is the recommended range for profiles
and calculated results.
3 Click Save.
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Exercises
5 Select the following tests by clicking the individual test buttons: CKL,
CKMBL.
6 Click Save.
7 Click Close to exit the dialog box.
1 Click Load.
2 Specify the path where the source files are located. (Default path: C:/Roche/
Instrument/TAS.)
Select the calculate result to be installed
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Training Manual · Version 1.3 4-19
Configuration COBAS INTEGRA 400 plus
Exercises
Formula tab 1 Select tests required in the formula in A, B, C, D fields and the factors in w, x, y, z
fields, if required.
2 Type the formula for the calculated results using A, B, C, D and w, x, y, z in the
Formula field, if required.
Laboratory tab 1 Enter Correlation Factor and Offset if correlating two different methods, if required.
2 Enter Calculated Result (Ratio) Unit and Factor/Offset if the lab units are different
from specified units, if required.
3 Enter the number of decimal places to be displayed in results
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Exercises
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Configuration COBAS INTEGRA 400 plus
Exercises
3 Click Close.
o Step 2: Select the Common Cuvette box to make sure that pipetting, for
example for predilution, is done from one cuvette only.
This feature is important for HBA1c whole blood.
o If the condition is not fullfilles a message will be generated
o Step 6: The formula is a mathematical expression created using A-D for the
tests and w-z for the constants, standard mathematical symbols are used such
as +, -, *, /, (, ).
1 Double-click Cleaners.
2 Click Load.
The name of the directory from where all test definitions are loaded is
displayed.
3 Click OK.
The Load Cleaner Definitions dialog box is displayed.
4 Select Cleaner.
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Exercises
If the ISE tests are not installed, click Load to install Activator and Deproteinizer,
which are both necessary for the Clean/Deproteinize Probes procedure.
As cassettes are used by the system, a history of all lot numbers, serial
numbers and expiration dates is presented on this tab.
You cannot change any of the cassette details except the warning level.
The value represents the percentage of tests remaining in the cassette.
a To define a user
1 In the System area, double-click the General icon or choose View > System
> General on the menu bar.
2 On the User Access tab, click Add.
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Training Manual · Version 1.3 4-23
Configuration COBAS INTEGRA 400 plus
Exercises
3 In the User box, type TRAINEE, then press the Tab key on your keyboard.
4 In the Level box, type 6, then press the Tab key on your keyboard.
5 In the User ID box, type TRAI, the press the Tab key on your keyboard.
6 In the Password box, type TRAI.
7 Repeat steps 2 to 6 for your own names and passwords with levels 2 to 6.
8 Click OK to exit the dialog box.
1 In the System area, double-click the General icon or choose View > System
> General on the menu bar.
2 Click the User Level tab.
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By clicking Default, you restore all ROCHE default settings for all actions.
1 In the System area, double-click the General icon or choose View > System
> General on the menu bar.
2 Click the Interface tab.
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Training Manual · Version 1.3 4-25
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Exercises
The interface setting is used to define the Host interface settings. The
parameters are standard interface protocol, and need to be defined
according to the hardware.
3 Do not make any changes and click Cancel to exit the dialog box.
1 In the System area, double-click the General icon or choose View > System
> General on the menu bar.
2 Click the System tab.
3 Type the serial number of your analyzer in the System Identifier box.
4 Set the Begin of Day time to 7:00.
BOD actions will not be performed on the next day if this check box is not
selected.
5 Set the system to go to Standby after 30 minutes.
6 Set the Sleeping mode after to 30 minutes.
7 Set the Alert Sound Frequency to 2000 Hz.
8 Select the language version English (default).
9 Do not select the External Liquid Waste and the Auto-Start boxes.
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Exercises
a To define a barcode
1 In the System area, double-click the General icon or choose View > System
> General on the menu bar.
2 Click the Barcode tab.
Barcode scanner: The values for Quiet Zone Ratio and No. of Equal Reads are
default values and must not be changed.
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Training Manual · Version 1.3 4-27
Configuration COBAS INTEGRA 400 plus
Exercises
a To configure ISE
1 In the System area, double-click the General icon or choose View > System
> General on the menu bar.
2 Click the ISE tab.
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Exercises
1 In the System area, double-click the Database icon or choose View >
System > Database on the menu bar.
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Training Manual · Version 1.3 4-29
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Exercises
a To customize demographics
1 In the System area, double-click the Database icon or choose View >
System > Database on the menu bar.
2 Click the Demographics tab.
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Exercises
6 Click Add.
Type the names of different physicians in the box with the arrow:
o Type Dr. Fortunato, then click Add.
o Type Dr. Watson, then click Add.
o Repeat for Dr. Billy and Dr. Dupont.
7 Click Save.
8 Click Close.
9 In the second Edit field, type Department.
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Training Manual · Version 1.3 4-31
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Exercises
10 Click the second Edit tab, click Add and proceed as above by typing the
names of the different departments.
o Emergency
o Surgery
o Pediatric
o Oncology
o Intensive Care
11 Click Save.
12 Click Close.
13 In the Order Demographics group, type Comment in the first Edit field.
14 Click Edit.
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Exercises
15 Click Add
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Training Manual · Version 1.3 4-33
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Exercises
a To handle results
1 In the System area, double-click the Database icon or choose View >
System > Database on the menu bar.
2 Click the Results tab.
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Exercises
1 In the System area, double-click the Database icon or choose View >
System > Database on the menu bar.
2 Click the QC Mode tab.
These QC rules are the rules that are applied when the QC Treatment box is
selected on the Test Definitions / Control tab.
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Training Manual · Version 1.3 4-35
Configuration COBAS INTEGRA 400 plus
Exercises
1 In the System area, double-click the Lab icon or choose View > System >
Lab on the menu bar.
2 Click the Sample Tubes tab.
The Defined Sample Tubes list shows in alphabetical order all tube types
defined by Roche.
3 Select Sarstedt 7.5 mL and 5.5 mL, and define Cup on Tube for both.
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Exercises
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Configuration COBAS INTEGRA 400 plus
Exercises
1 In the System area, double-click the Lab icon or choose View > System >
Lab on the menu bar.
2 Click the Sample Types tab.
3 The Defined Sample Types list shows the defined sample types in
alphabetical order.
4 Click New to define additional sample types.
5 Type the name of the sample type. This name consists of up to 10
alphanumeric characters and must be unique.
6 Type the short name. This name consists of up to 3 alphanumeric
characters. Avoid leading spaces!
The sample type short name is used for the Host interface protocol and
barcode labels.
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Exercises
a To define a rack
The Defined Racks list shows all defined rack types in alphabetical order.
ISE and Cassette in this list are used for all cassette racks and the ISE rack.
These cannot be deleted.
3 Click New to define a new rack type.
4 Type the Rack Name CALQC.
5 Choose the Tube Type COBASCUP.
6 Click Add in the Rack Number group.
7 Type rack numbers and codes:
1 1 Disabled
2 2 Disabled
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Training Manual · Version 1.3 4-39
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Exercises
a To define positions
1 In the System area, double-click the Lab icon or choose View > System >
Lab on the menu bar.
2 Click the Reserve Positions tab.
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Exercises
Place Calibrators on the rack from the highest to the lowest concentration.
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Training Manual · Version 1.3 4-41
Configuration COBAS INTEGRA 400 plus
Exercises
a To handle flags
1 In the System area, double-click the Result Handling icon or choose View
> System > Result Handling on the menu bar.
On this dialog box, you define automatic actions per test class for
calibration, control, sample, and ratio results.
2 Click the Result Handling box in the top left corner of the dialog box to
enable the Result Handling Table.
3 Select No Flag, and choose the Accept action for the following test classes:
o Substrates
o Enzymes
o Protein
o TDM
Make these definitions for:
o Calibration
o Quality Control
o Samples
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In the System area, double-click the Processing icon or choose View > System
> Processing on the menu bar.
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Training Manual · Version 1.3 4-43
Configuration COBAS INTEGRA 400 plus
Exercises
This dialog box serves to associate tests with group titles and to specify the
sequence within a printout.
2 Define the following sequence:
a. Click Add Group.
b. Type Chemistries.
c. Move the following tests to this group: GLUL, IGA, CHOLL, TP, ALB.
Select the different tests and use the Up Arrow and Down Arrow to
move the tests or select and drag them to the new group.
3 Repeat the previous step for the following groups:
o Enzymes
a. Click Add Group.
b. Type Enzymes.
c. Move the following tests to this group: ASTL, ALTL, CKL, CKMBL.
o ISE
a. Click Add Group:
b. Type ISE.
c. Move to the following tests to this group: NA-D; K-D; CL-D; LI-D.
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Exercises
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Exercises
Click Load to load the actual Extra Wash Cycle table from the TAS directory.
The Extra Wash Cycles tab shows when the Cleaner cassette has to be used.
Clear the Active box to disable a programmed Extra Wash Cycle, if the test-
reagent combination is not in use
Good job!
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Training Manual · Version 1.3 4-47
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Exercises
Step 1: Archiving
a To archive definitions
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Exercises
3 Click OK
The whole system configuration (General, Database, Lab, Result Handling,
Processing) will be saved to your floppy disk, with the exception of the rack
and extra wash cycles definitions, which have to be archived separately.
4 When finished, insert a second diskette in the drive and select Complete
Test Definitions. (The test, cassette, control, calibrator, diluent, cleaner,
ISE fluid definitions are included in the Complete Test Definitions. Not
included are the control and calibrator lot numbers and values, and the
ratio and profile definitions.)
5 Click OK.
6 Select the test definitions you want to archive or to save.
7 Click Archive.
Step 2: Loading
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Exercises
4 Click Browse to copy the system parameters from the floppy disk in drive
A, then click OK.
5 When finished, remove the diskette and insert the Complete Test
Definitions diskette.
6 In the Configuration work area, choose File > Load Definitions
7 Select Complete Test Definitions, then click OK
8 Click Browse to copy the test definitions from the floppy disk in drive A,
then click OK.
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Review Questions
Review Questions
1. How many different operator access levels are on the COBAS INTEGRA
400 plus?
...................... ..........................................................................................................
...................... ..........................................................................................................
3. Where can you check the control values for each individual test?
...................... ..........................................................................................................
...................... ..........................................................................................................
...................... ..........................................................................................................
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Review Answers
Review Answers
1. How many different operator access levels are on the COBAS INTEGRA
400 plus?
There are six different levels of operator access.
3. Where can you check the control values for each individual test?
In Configuration / Definitions / Controls.
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Orders
Roche Diagnostics
Training Manual · Version 1.3 5-1
Orders COBAS INTEGRA 400 plus
Roche Diagnostics
5-2 Training Manual · Version 1.3
COBAS INTEGRA 400 plus Orders
Lesson
Lesson
Introduction
Order ID Each order must have an order ID, which may be alphanumeric (for example
AA-1234) or numeric (for example 1234).
Order IDs are valid until they are deleted. Typically, the system is configured
to delete processed orders automatically every morning, and with it the order
IDs are deleted.
You then can use the same order IDs the next day. You can purge orders only
when the order has been processed, that is, when the results have been
accepted and transmitted to the host, provided you work with a host system.
Patient ID A patient ID identifies a particular patient. You can have two patients with the
same name (and birth date), but different patient IDs. If Patient ID is turned
off in Configuration / Database / Demographics, patient demographics are
not available.
Racks o If you use barcodes that do not contain sample type information:
O Define both tube type and sample type for a rack (Configuration / Lab /
Racks). You can then load urine samples, for example, onto a rack that
is specifically defined for urine.
o If you use barcodes that do contain sample type information:
O Define only the tube type for a rack (Configuration / Lab / Racks).
O You can then load urine samples, for example, onto a rack that is
specifically defined for urine.
o If you are working without barcodes:
O Define only tube type for a rack (Configuration / Lab / Racks)
O Different sample types are placed on the same rack.
Sample handling o If you use barcodes (with or without sample type information):
O The process of placing samples is automatic. Load the samples onto a
suitable sample rack and insert the rack into the rack platform. The
system then reads the barcodes to uniquely identify each sample.
o If you are working without barcodes:
O The samples are automatically assigned to appropriate rack positions, if
automatically Assign Rack Positions is enabled (Configuration /
Database / Automatic Actions).
You cannot mix tube sizes on the same rack. For example, you cannot put 5 mL and
7 mL tube types on the same rack.
Roche Diagnostics
Training Manual · Version 1.3 5-3
Orders COBAS INTEGRA 400 plus
Lesson
Worklist This tab gives a clear and comprehensive overview of the active orders and
tests, and provides easy access to the tasks you perform most frequently on
these items, such as editing and validating.
Calibration This tab allows you to request calibrations for specific tests.
Quality control This tab allows you to request quality controls for specific tests.
Context menu
You can right-click a test, order, calibration, or control in any tab to display
the context menu. It contains one or more of the following frequently used
commands:
Copy Order Copy the details of the current order to the clipboard.
Use with Paste Order to create multiple orders with
the same content.
Multiple Tests Request the same test several times for the order.
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Lesson
Paste Order Paste the details of an order into the current order.
(You must previously have saved the details of
another order and used Copy Order.)
Sample Handling Review the rack numbers and rack positions for the
selected sample.
Use Last Order Re-display the details of the last order you used.
Use Last Patient Re-display the details of the last patient you used.
Roche Diagnostics
Training Manual · Version 1.3 5-5
Orders COBAS INTEGRA 400 plus
Lesson
Sample tab
Use the Sample tab to create, modify, review, or delete an order for tests on
one or more samples from a patient. You can select individual tests, or a
profile containing several tests.
B
C
D
F
G
H
A Use the Patient and Orders group to display or specify patient and order details if you are
creating a new order or modifying an existing one.
B Select a sample type for the test being added. The initial value of this list is Automatic, which
means that the default sample type (as specified in the test definition) is to be used.
C To manually assign a sample to a rack position, first select a rack from the first drop-down
list, and then select an available rack position from the second drop-down list. The Position
drop-down lists are available while a Sample Type other than Automatic is selected.
D Select a test group to customize the type and number of test buttons displayed. Each test
can belong to one or more groups, depending on the configuration of your system. When
you specify the name of a group in the Group box, only buttons for tests that belong to that
group are displayed.
E Click one or more of the profile and test buttons to select the tests for the order you are
creating. For tests only, you can remove a test from an order by clicking the corresponding
button a second time. Use the scroll bars to display more tests, if necessary. Use the Group
list to select a predefined group of tests, for example all STAT tests. Test groups are only
available if they were previously defined in Configuration / Definition / Test).
F The Sample/Test Summary group lists the tests selected for the current order.
G Select this check box to give the order STAT priority.
H Click Clear to clear the boxes in the tab.
I Click Save to save the current order.
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Lesson
Roche Diagnostics
Training Manual · Version 1.3 5-7
Orders COBAS INTEGRA 400 plus
Lesson
Roche Diagnostics
5-8 Training Manual · Version 1.3
COBAS INTEGRA 400 plus Orders
Exercises
Exercises
Exercise 1
a To create orders
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Training Manual · Version 1.3 5-9
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Exercises
11 Click OK.
A
B
A Profiles
B Tests
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Exercises
15 Click Save
The Sample Handling dialog box is displayed.
16 Click the rack number and choose the first position in the drop-down list.
17 Click OK.
18 Click Save.
In the same way, create orders according the following worklist:
Patient
Patient ID Birth date Nº Tests Other
Name
4 Type 15.
5 Click OK.
6 Click Save.
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Exercises
You can also click on the Find icon to open the Find window.
Use the date format as indicated in the bottom right of your screen.
6 Click OK and wait until the System has created the orders.
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Exercises
a To modify an order
1 Click Clear
2 Type *in the Order ID box.
3 Press Enter
4 Choose number 101 in the list.
5 Add IGA to the Sample.
6 Click Save.
a To delete a test
1 Click Clear.
2 Type the Order ID 105 in the Order Id box.
3 Click deselected ALTL.
4 Click Save.
Alternatives to delete a test o Select Test, and press the Delete button on your keyboard.
o Choose Edit > Delete from the menu bar.
o Right-click the test, and choose Delete.
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Exercises
a To delete an order
1 Click Clear.
2 Type order ID 106 in the Order ID box.
3 Choose Edit > Delete from the menu bar, or right-click the Order number
box and choose Delete Patient Order.
You are prompted to confirm the deletion.
4 Click Yes.
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Exercises
a To dilute a test
1 Select Clear.
2 Type order No. 107 in the Order ID box.
3 In the Sample/Test Summary group, right-click GLUL and choose
Dilutions.
4 Select Factor A.
5 Click OK.
6 In the Sample/Test Summary group, the Glucose test shows the selected
dilution factor.
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Exercises
In sample 105, there is not enough serum, you have to use Cup on Tube.
1 Click Clear and remove the sample rack from the instrument.
2 Type order 105 in the Order ID box.
3 Right-click the entry for order 105, and choose Sample Handling.
This option is only available if Cup on Tube is activated for the predefined primary
cup (Configuration / Lab / Sample Tubes) and the according sample rack is not on
board.
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Exercises
1 Click Clear.
2 Type the order No. 102.
3 Right-click an order in the Sample/Test Summary group and choose Copy
Order.
a To print a loadlist
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Exercises
a To request calibrations
3 Click Save.
o Only the new calibration requests, displayed as white folder, can be deleted.
o Gray folder means calculated result, but not validated.
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Exercises
3 Click Save.
o Only the new quality controls, displayed as white folder, can be deleted.
o Gray folder means calculated, but not validated.
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Orders COBAS INTEGRA 400 plus
Exercises
Step 6 — Starting up
a To start up
1 Choose File > Print Report > Missing & Blocked to print your
Missing & Blocked worklist.
2 Make sure you have all necessary cassettes, racks and calibrators, samples
with or without barcodes loaded on the analyzer.
3 Check if you need diluents and place them accordingly.
4 Ask your instructor for missing material.
5 Start your system: Press F11 or click the Start button in the navigation bar.
You have to click the Start button a second time if the instrument is in sleeping
mode.
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Exercises
Exercise 2
a To create orders
1 Load the sample rack with barcodes on board before creating orders.
2 Click the Orders icon in the navigation bar.
The Sample tab is active.
3 Click on the drop-down button next to the Order ID group
All order numbers of the samples placed on board are displayed.
4 Choose one order number, press Enter, select the test buttons according to
the first entry of the list below.
5 Click Save.
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6 Use the same procedure to create the orders of the other samples.
Step 3 — Starting up
a To start up
1 Choose File > Print Report > Missing & Blocked to print your
Missing & Blocked worklist.
2 Make sure you have all necessary cassettes, racks and calibrators, samples
with or without barcodes loaded on the analyzer.
3 Check if you need diluents and place them accordingly.
4 Ask your instructor for missing material.
5 To start your system, Press F11 or click the Start button in the navigation
bar.
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Exercises
Roche Diagnostics
5-24 Training Manual · Version 1.3
COBAS INTEGRA 400 plus Results
Results
Roche Diagnostics
Training Manual · Version 1.3 6-1
Results COBAS INTEGRA 400 plus
Roche Diagnostics
6-2 Training Manual · Version 1.3
COBAS INTEGRA 400 plus Results
Lesson
Lesson
About results
Result handling and the way that information is displayed in the Results work
area is determined in the system configuration.
Result handling Typically, the system is set up to automatically accept unflagged results. They
are then displayed in the Sample, Calibration, and Quality Control tabs in the
Results work area.
Flagged results Flagged results are usually displayed in the Validate tab in the Results work
area so that you can review them, and either accept them manually, or rerun
the test.
Raw data You can specify how long raw data are kept in the database in Configuration /
Database / Automatic Actions. You can look at raw data values and a graph of
the raw data over time in the Results work area.
Context menu
Exclude from statistics Exclude the selected control result from statistics. The
result is grayed out in the Quality Control tab.
Test Status Display information on the status of the test for the
selected calibration or control.
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Training Manual · Version 1.3 6-3
Results COBAS INTEGRA 400 plus
Lesson
Validate tab
o This tab lists orders, calibrations and controls that either require
validation, are blocked, or are not on board.
o You can accept a result or rerun it.
o You can request a dilution for tests that you decide to rerun.
Selecting what information to There are two options in the filter list on the toolbar:
display
Unaccepted Only unaccepted results are displayed.
If you choose Unaccepted, the filter icon is displayed on the tab label.
The Validate tab can contain the following folders and information:
Blocked Orders with at least one test with the Blocked status.
Not On Board Orders for which there are tests to be performed, and
for which the sample is not on board the system.
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Lesson
Working with results To follow the logical job sequence, work through the entries in the list from
top to bottom.
Click a sample, calibration, or control order in the Validate list to display the
corresponding results on the right.
Reference range The reference range for the test is indicated by the parentheses (---). The
asterisk * shows the result value in relation to the reference range:
*--(---)--- Result less than reference range.
<--(---)--- Result much less than reference range.
---(-*-)--- Result inside the reference range.
---(---)--> Result much greater than reference range.
---(---)-*- Result greater than reference range.
Sample tab
This tab lists all results of the orders and patients that are currently on the
system.
Use the Sample tab to:
o Monitor patient results over time.
o Delete Patient demographics.
Orders & Patient list The Orders & Patient list contains orders with unaccepted and accepted
results.
Results list The Results list contains all results for the selected order.
To review results, whether accepted or not, you can list them by:
o Patient ID/Order Date
o Patient name/Order Date
o Order Date/Order ID.
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Training Manual · Version 1.3 6-5
Results COBAS INTEGRA 400 plus
Lesson
Calibration tab
Use the calibration tab to:
o Review calibration curve parameters for a specific test.
o Review calibration details in graphical form or as raw data.
Results list Shows the calibration history for the selected test.
Scroll to right to display flags and actions, and test and calibrator lot numbers.
Date Calibrated column If a dotted line is displayed instead of the date, the calibration is running or is
not accepted.
Change of the calibrator lot Is displayed as a dotted line across all the columns.
sSince Software Version 3.4 it is possible to add a comment also for accepted
calibrations
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Lesson
Test list Shows all the tests on the system and their associated controls by clicking on
By Test
Results list Shows control results for the selected test or control.
Date & Time If a dotted line is displayed instead of the date, the control is running or is not
accepted.
Statistics To display statistics for the selected test and its assigned controls. The statistics
displayed depend on which control mode button (Accuracy, Precision, or
Limit) is selected.
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Training Manual · Version 1.3 6-7
Results COBAS INTEGRA 400 plus
Lesson
o Results are removed from the Quality Control tab if you use a new control lot.
o Up to three controls can be displayed for one test.
o Each control is displayed using a unique symbol (a square, diamond, circle etc.).
Flagged results are displayed in red.
o Right-click a result and choose Exclude from Statistics to exclude the selected
result from the statistical analysis.
o To define a period, click From on the toolbar and use the View of QC Results
dialog box to make the definitions.
o Since Software Version 3.4 it is possible to add a comment also for accepted
quality controls.
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Lesson
Accepting result or rerunning When one or more results in an order are flagged, all the results for that order
tests are displayed in the Validate tab, provided you have chosen All in the filter list
on the toolbar to display all results. You can accept all of the results, or you
can accept some and rerun others. Note that results are flagged to indicate a
problem, and you should not accept them without careful consideration.
Monitoring patients When the same test has been performed several times for the same patient,
you can use the monitoring facility to compare the test results over time.
Purging orders You can purge orders manually at any time, or delete them automatically at
BOD.
o Purging orders removes the order number from the Orders work area.
o The main reason for purging orders is to free the order IDs for re-use.
o The results are not removed from the Results work area.
Preconditions for purging orders:
o There are no pending tests belonging to this order.
o The associated results have been accepted.
o The associated results have been transmitted to the host, if necessary.
o The associated samples have been removed from the system.
Archiving results o You can save results on the system for future reference.
o If you archive results in this way, you cannot reload them onto the system;
you can only review them.
Patient information o The system keeps patient information unless you delete the patient
manually.
o When you delete a patient from the database, all results and orders
associated with that patient are also deleted.
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Training Manual · Version 1.3 6-9
Results COBAS INTEGRA 400 plus
Lesson
Printing results
There are three kinds of printouts:
Results report The Results report lists every result (accepted and unaccepted) on the system.
You can specify ranges for order ID, patient ID, and for the order date.
The results are listed by order ID in ascending order.
For each order creation date, a new page is started.
Final Report The Final Report lists patient demographics, order details, and accepted test
results for a single patient.
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6-10 Training Manual · Version 1.3
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Lesson
QC report Use the Quality Control reports to review the quality control history of
individual tests.
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Training Manual · Version 1.3 6-11
Results COBAS INTEGRA 400 plus
Exercises
Exercises
Step 1 — Validating results
Validate calibrations, quality controls, and patients, using results obtained by
the exercises in the chapters Test run, Calibration and quality control, and
Orders.
a To validate results
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Exercises
Validate the calibration 5 Select a calibration order in the To Validate folder to display test results on
results the right.
6 List the different flags you can find:
....................................................................................................................
....................................................................................................................
....................................................................................................................
7 Double-click a result line in the list of results.
The Result Detail dialog box is displayed, where you get information about
recommended actions for flagged results.
The dotted blue line corresponds to the previous calibration, the black line
to the new calibration.
For this exercise, you have to repeat the calibration with fresh calibrator.
8 Click Rerun in the Calibration Detail dialog box, or select a result line of
the calibration and press Rerun.
9 Click Accept if you want to accept the calibration.
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Training Manual · Version 1.3 6-13
Results COBAS INTEGRA 400 plus
Exercises
Validate patient results 10 Select a patient order in the To Validate folder to display test results on the
right.
11 Right-click a patient result and choose Rerun.
The Dilution dialog box is displayed.
Flags It is important to recognize the meaning of a flag and how to resolve its cause.
There are three groups of flags that show up on the screen according to a
priority:
o F1: These flags provide information about how the result was generated.
Different sets of flags are applied to calibrators, controls and samples.
o F3: These flags represent errors generated in result calculation.
o F4: These flags are for result evaluation checks (QC, reference range and
cut-off).
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Exercises
Accepting a flagged calibration, QC or result changes the letter to a small letter, such as c, q, r.
Refer to the Flags sections in the Online Help to get more detailed information
about flags in general and to get information on how to solve problems in
connection with flag groups 3 and 4.
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Training Manual · Version 1.3 6-15
Results COBAS INTEGRA 400 plus
Exercises
1 Double click one of the sample test result that is out of reference range.
The Result - Sample - Detail dialog box is displayed:
2 Click Rate Info to open the Sample Rate Info dialog box.
The Reaction tab is displayed and allows you to the view the reaction
curve.
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Exercises
3 Click Print.
4 Select the Raw Data tab to view the raw data.
5 Click Print.
6 Click Close
a To rerun results
1 Right-click any test result that is outside the reference range, and choose
Rerun.
2 Select As Original or Factor A, depending on your result.
3 Click OK.
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Training Manual · Version 1.3 6-17
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Exercises
a To accept results
1 Right-click one test result that is within the reference range, and choose
Accept.
2 What happens to this result?
....................................................................................................................
....................................................................................................................
....................................................................................................................
3 Repeat the action for all not accepted tests for this order, or select Accept
all.
What happens to this order when all results are accepted?
....................................................................................................................
....................................................................................................................
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Exercises
a To modify orders
2 Click Edit.
There is direct link to the Order tab, where you can select additional tests.
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Exercises
a To monitor results
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Exercises
This feature gives you an overview of the patient’s results over time.
In the Test box at the bottom of the screen, you can select the other tests
for this order to see their monitor display.
a To specify a query
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Exercises
9 Use the same procedure to create a query for STAT samples, using the
Advanced tab instead of the Sample Order tab.
The Reset button sets each field to the default value (no query is made).
The Delete button is used to remove a selected query.
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Exercises
Statistics by test
Statistics by control.
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6-28 Training Manual · Version 1.3
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Exercises
1 Choose File > Print QC Report from the menu bar, and the QC Report
dialog box is displayed.
The following figure shows the QC Report dialog box with the By Test view
selected:
2 Set the period for which the QC report should be generated by clicking
From.
3 Select the control types for which a report should be generated:
Accuracy, Precision, Limit
4 These settings will remain active when this dialog is opened the next time.
If you do not select any type, no report will be generated and printed.
5 Choose whether a report should be generated for the controls of the
selected test only or of all tests.
If you select Only Selected Test, the results of all controls of the test will be
printed.
The Only Selected Test option is only available while a test is selected in the
folders list of the Quality Control tab.
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Exercises
3 Type the values to define your selection: Order ID from 100 to 120.
4 If you do not provide any selection criteria, all available results will be
included in the report.
5 Click Print to generate the report and print it.
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Exercises
1 Choose File > Print Report > Results from the menu bar.
The Print Result Query dialog box is displayed.
2 Type the values to define your selection.
If you do not provide any selection criteria, all available results will be
included in the report.
3 Click Print to generate the report and print it.
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Exercises
a To print a journal
a To archive results
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Exercises
4 Specify a file name, file type, and a folder for the archive.
5 Type over the blue highlighted default name, but do not use an extension
(e.g. Jan2001 is OK, but Jan2001.txt is not OK).
6 Click OK.
a To review results
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Exercises
2 Select the filename, file type, and the folder where files are located.
3 Click OK.
The Review Results dialog box is displayed.
4 Use Find to locate a specific test, patient name, or patient ID.
5 Click Close.
a To purge results
2 Select or clear the Calibration, Quality Control, and Samples check box to
choose the kind of test results you want do delete.
3 In the To box, type the date up to which you want to delete the results. All
results older than that date will be deleted.
4 Click Purge.
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Exercises
1 On any of the tabs of the Results work area, right-click an item, and choose
Delete from the context menu.
The Confirm Delete dialog box is displayed. The text on this box tells you
exactly what data will be deleted.
2 Click Yes.
a To delete a patient ID
1 Click the Sample tab.
2 Click the column header to display the Patient Name or Patient ID list.
3 Right-click any patient name or ID, and choose Delete.
4 On the Confirm Delete dialog box, click Yes.
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Roche Diagnostics
6-36 Training Manual · Version 1.3
COBAS INTEGRA 400 plus Service
Service
At the end of this chapter, you will be familiar with the most relevant
maintenance tasks to insure optimal performance of the COBAS INTEGRA
400 plus. You will be able to:
o Access the Service software, describe screens, buttons and their function.
o Identify automatic and interactive service actions.
o Describe the Begin of Day actions.
o Start and perform Service actions.
Roche Diagnostics
Training Manual · Version 1.3 7-1
Service COBAS INTEGRA 400 plus
Lesson
Lesson
Due o This tab lists service actions that are nearly due, due and overdue.
o Overdue items are highlighted when you click the Due tab.
o The items that are not highlighted are almost due (less then 100%).
o The second column shows the time it takes to perform the service action.
Begin of Day o This tab lists service actions that are to be automatically performed at the
Begin of Day.
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Lesson
Perform o Click Perform to perform the highlighted service action. The dialog box
that lists the instructions for performing the service action is displayed.
Done o Click Done if you do not intend to perform the service action but wish to
reset the counters to zero. The service action is removed from the Due tab.
Use this function for special cases only, e.g. if you changed both probes by
performing one service action.
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Training Manual · Version 1.3 7-3
Service COBAS INTEGRA 400 plus
Lesson
The Service-Detail dialog box shows the actual status of the counter with the
elapsed percentage of the function. The status shows whether the function’s
due time depends on a timer or event counter, or on BOD.
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7-4 Training Manual · Version 1.3
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Lesson
1 Click the Due or All tab and select one service action.
2 Click Perform, or right-click the action and choose Perform from the
context menu.
The service action dialog box is displayed.
3 Follow the instructions listed on the dialog box.
4 Click Help on the dialog box.
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Training Manual · Version 1.3 7-5
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Exercises
Exercises
o Replace probes.
o Replace ventilation filters.
o Replace absorbance photometer lamp (done only theoretically).
This service action takes 26 minutes.
o Clean/deproteinize probes.
o Clean probes manually.
o Clean initialization posts and surfaces.
o Clean and replace water filter.
o Clean waste box fitting.
o Clean sample and reagent area.
o Deproteinize electrodes.
o Activate electrodes.
o Clean ISE wash tower automatically.
o Electrode service.
o Prime ISE calibrators.
o Replace tubing of ISE module.
o Replace ISE electrodes.
o Clean ISE tower manually.
o Replace ISE tower.
o ISE Performance Check
Since the SW 3.4 we have implemented from the diagnostics software the new service action ISE
Performance Check. This service action is very useful for troubleshooting purpose.
Roche Diagnostics
7-6 Training Manual · Version 1.3
COBAS INTEGRA 400 plus ISE module
ISE module
This section describes the ISE module and how to use it.
At the end of this section you will be able to:
o Run ISE tests on samples.
o Request ISE calibrations.
o Check ISE calibrations.
o Handle the ISE rack.
o Maintain the ISE module.
o Describe the Begin of Day actions of the ISE module.
o Describe the ISE pipetting sequence.
o Set up the ISE module.
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Training Manual · Version 1.3 8-1
ISE module COBAS INTEGRA 400 plus
Roche Diagnostics
8-2 Training Manual · Version 1.3
COBAS INTEGRA 400 plus ISE module
Lesson
Lesson
Introduction
The ISE module is a measurement system for electrolytes that runs
independent of the FP and absorbance photometry systems. The ISE module
uses the same samples, racks and tubes that are used for photometric
measurements and samples are transferred using the probes and transfer arm.
The ISE module also uses special solutions which are kept in bottles on the
ISE rack, the others are located on the ISE module.
The COBAS INTEGRA Ion-Selective Electrode (ISE) module makes
quantitative determinations of the following electrolytes:
o Sodium
o Potassium
o Chloride
o Lithium
The ISE module performs direct assays on undiluted serum or plasma
samples (sodium, potassium, chloride and lithium). It performs indirect
assays on diluted serum, plasma or urine samples (only for sodium,
potassium and chloride ).
Measurement modes
There are three measurement modes:
The dilutions and the mixing are performed automatically in the ISE tower.
Roche Diagnostics
Training Manual · Version 1.3 8-3
ISE module COBAS INTEGRA 400 plus
Lesson
Urine
ISE Direct ISE Indirect (Indirect)
Sodium l l l
Potassium l l l
Chloride l l l
Lithium l x x
ISE measurements ISE measurements and photometric measurements are carried out at the
same time as they are independent of each other (ISE measurements do not
use cuvettes or the analyzer rotor, or the photometers). In addition, all
requested ISE measurements on a specific sample (or calibrator) are
performed in parallel, the measurements are made at each electrode at the
same time.
Roche Diagnostics
8-4 Training Manual · Version 1.3
COBAS INTEGRA 400 plus ISE module
Lesson
The following figure shows the main parts of the ISE module:
A
D
B
E
C
F
G
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Training Manual · Version 1.3 8-5
ISE module COBAS INTEGRA 400 plus
Lesson
Peristaltic pump A fluid pump that draws the solutions through the
electrode block and then into the sample waste.
Tubing (not shown) Tubing is used to connect the ISE module with the
water and waste system. Tubing is also used for
sample waste, ISE Reference Electrolyte, and ISE
calibrators, which are contained in bottles on the
ISE module.
Sample transfer arm (not The sample transfer arm uses probe C to pipette
shown) samples into the ISE tower. If required, samples
may be diluted automatically.
Valves (not shown) A set of valves controls the flow of liquids through
the tubing.
ISE distribution block A transparent plastic block used for liquid and air
distribution within the ISE module.
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8-6 Training Manual · Version 1.3
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Lesson
Principles of operation
1. The sample is pipetted from the sample tube (located on a sample rack)
into the ISE tower. Depending on the pipetting mode, the sample is diluted
with system water. Mixing is performed with four air jets arranged in a
circle. These jets blow air into the tower to produce a homogenous
mixture.
2. The other solutions (ISE solution 1-3, ISE Deproteinizer, ISE Etcher and
activator) are pipetted from the ISE rack into the ISE tower by the sample
probe, when required.
3. The sample is divided into segments. The first (shorter) segments are used
for cleaning, followed by a longer segment, on which the measurements
are made.
4. The sample is passed to the ion-selective electrodes by the action of the
peristaltic pump.
5. The exact positioning of segments is ensured by fluid sensor 2 in the
measuring channel.
6. In the meantime, the ISE tower is washed with system water and then
dried with air.
7. The ISE Reference Electrolyte is passed through the reference electrode
and into the measuring channel downstream of the electrodes. The ISE
Reference Electrolyte completes the electrical circuits for each electrode so
that measurements can be made. When the measurements are made, the
sample and ISE Reference Electrolyte are stationary.
8. A one-point calibration is performed after each sample measurement
using the relevant calibrator, which is located on the left side of the ISE
module.
9. The electrolyte concentration of the sample is calculated.
10.The measuring channel is cleaned before the next measurement.
Determination of lithium The lithium electrode is not exclusively selective for lithium ions; sodium and
potassium ions also contribute to the measured signal. These contributions
are determined for each lithium measurement and each lithium result is
corrected accordingly.
Therefore, to make lithium determinations, you must have both sodium and potassium
electrodes installed and working.
Roche Diagnostics
Training Manual · Version 1.3 8-7
ISE module COBAS INTEGRA 400 plus
Lesson
Calibrations
The ISE module requires frequent calibration to ensure the reliability of the
test results obtained. After a sample has been measured, the corresponding
calibrator (depending on the measurement mode) is automatically
transported to the electrode block, positioned and measured in the same way
as a sample. All the required calibrations are performed automatically,
although you can request a main calibration at any time.
Main calibration Sodium, potassium and chloride are calibrated with a two-point calibration
using ISE Solutions 1 and 2. Lithium is calibrated with a three-point
calibration at fixed intervals using ISE Solutions 1, 2 and 3. The time interval
for main calibrations is 5 hours.
Since the SW Version 3.4 is the calibration interval of 5 hours a Roche parameter and
not changeable anymore for the user.
One-point calibration The ISE module automatically performs a one-point calibration with the
corresponding ISE calibrator, depending on the measurement mode. For
example, in direct mode, the ISE Calibrator Direct is used for the one-point
calibration.
One-point calibrations are performed within the ISE cycle of 53 seconds.
STAT orders
ISE-STAT samples are pipetted before routine samples.
Electrode service
Electrode service is a service procedure that is performed automatically at the
Begin-of-Day time. While Electrode service is taking place, the ISE module
cannot carry out any tests.
During Electrode service:
o The electrodes are cleaned with ISE Deproteinizer to prevent protein build
up on the electrodes and in the tubing.
o The surface of the sodium electrode is etched (with the etcher solution
located on the ISE rack).
o Electrodes are activated. The activator is pipetted from the ISE rack into
the ISE tower and drawn through the measuring channel (performed
twice), afterwards the electrodes are rinsed with ISE calibrator direct.
Roche Diagnostics
8-8 Training Manual · Version 1.3
COBAS INTEGRA 400 plus ISE module
Lesson
ISE status
Status Operating All ISE measurements are made in one of three measuring modes (direct,
indirect and urine); in addition, the electrodes are calibrated at regular
intervals and recalibrated after each measurement.
Status Standby If there is no measurement after 3 minutes in the status Ready, the ISE module
switches to Standby mode. In Standby mode, ISE Calibrator Direct is pumped
into the measuring channel and transported slowly through the system every
3 minutes. ISE Calibrator Indirect/Urine and ISE Reference Electrolyte are
primed through the ISE module at fixed intervals (every two hours).
Standby mode helps to prevent the following problems:
o Overflow of ISE Reference Electrolyte backwards into the measuring
channel, which can damage the electrodes because of the high ion
concentration of the ISE Reference Electrolyte.
o Crystallization of salts in the tubing (blockage).
o Increases in the concentration of the ISE Calibrator Indirect/Urine within
the tubing.
ISE service actions The service of the ISE module is supported by on-line service software
(Service, ISE). The software guides you through the service procedures to be
performed at fixed time intervals or at other times depending on the work
load. Some user defined service actions are performed automatically by the
system during the Begin-of-Day procedure.
Roche Diagnostics
Training Manual · Version 1.3 8-9
ISE module COBAS INTEGRA 400 plus
Lesson
o All bottles should have caps, except the activator and SDR 2 bottle.
o Any other positions can be used for e.g. diluents.
o 9% NaCl can only be used in the ready to use 25ml NaCl bottles placed on the
ISE-rack. It is not possible anymore to use 9% NaCl in a 10ml bottle and placed
on the ISE-rack
Roche Diagnostics
8-10 Training Manual · Version 1.3
COBAS INTEGRA 400 plus ISE module
Lesson
2 Check the positions of ISE calibrators and the ISE Reference Electrolyte on
the ISE module.
Please ensure that the ISE Reference Electrolyte and ISE calibrators are in
their correct locations.
o ISE Calibrator Direct
o ISE Calibrator Indirect/Urine
o ISE Reference Electrolyte
The ISE Reference Electrolyte is not a calibrator and it should not be used
as such. The ISE Reference Electrolyte is automatically used with the
reference electrode (and only the reference electrode) to close the electrical
circuit with the measuring electrodes.
Using the ISE Reference Electrolyte as a calibrator or a sample will damage
the electrodes.
3 Create an order.
Create an order for ISE tests using the Orders work area in the same way as
for other tests.
ISE tests are multitests, meaning that all ordered ISE tests for one sample are
performed simultaneously with one sample pipetting.
4 Load samples.
Place your sample in any convenient position, on a sample rack, just as you
would do with any other test (barcoded samples) or use the tool Place
Items (not barcoded samples).
Roche Diagnostics
Training Manual · Version 1.3 8-11
ISE module COBAS INTEGRA 400 plus
Lesson
5 Check results.
The results are displayed in the same way as any other results.
Roche Diagnostics
8-12 Training Manual · Version 1.3
COBAS INTEGRA 400 plus ISE module
Lesson
ISE solutions
ISE calibrators
Intended use The ISE Solutions 1, 2, 3 and the ISE Calibrators Direct and ISE Calibrators
Indirect/Urine are in vitro diagnostic calibrators intended for the calibration
of the COBAS INTEGRA 400 ISE module; for the quantitative determinations
of sodium, potassium, chloride and lithium.
Shelf life Store all ISE calibrators at 15 to 25° C. See label for expiration date.
On-board stability
Activator
Since the SW Version 3.4 it is possible to enter separately the Lot No. and expirations
date for SOL-1, SOL-2 and SOL-3.
Roche Diagnostics
Training Manual · Version 1.3 8-13
ISE module COBAS INTEGRA 400 plus
Lesson
Intended use The ISE Reference Electrolyte is an in vitro diagnostic solution providing a
strong stable ion reference potential in the reference electrode for the
measurement of sodium, potassium, chloride and lithium.
The ISE Deproteinizer and ISE Etcher are cleaning solutions intended for use
with the COBAS INTEGRA ISE module for cleaning the ion-selective
electrodes.
Active ingredients .
The ISE Etcher contains ammonium hydrogen difluoride. Irritating to eyes and skin.
In case of contact with eyes, rinse immediately with plenty of water and seek medical
advice.
Roche Diagnostics
8-14 Training Manual · Version 1.3
COBAS INTEGRA 400 plus ISE module
Lesson
ISE Solution 1 Yes ISE rack 6 Two-point calibration of sodium, chloride and
potassium and for the three-point calibration
of lithium. Also used for the initialization of
the ISE module.
ISE Solution 2 Yes ISE rack 5 Two-point calibration of sodium, chloride and
potassium and for the three-point calibration
of lithium.
ISE Calibrator Direct ISE One-point calibration after each ISE direct
module measurement, which is performed once every
ISE cycle when the module is in ISE direct
mode.
Also used during ISE standby and for
servicing purposes.
ISE Etcher Yes ISE rack 3 A cleaning solution intended for use with the
ISE module for cleaning the sodium electrode
during ISE service.
ISE Deproteinizer Yes ISE rack 8 A cleaning solution intended for use with the
ISE module for cleaning the probes during
BOD, the ion-selective electrodes, ISE tower
and tubing during ISE service.
ISE Activator No ISE rack 2 Activates the electrodes in ISE service actions
and is also used for the initialization of the ISE
module and for BOD.
Roche Diagnostics
Training Manual · Version 1.3 8-15
ISE module COBAS INTEGRA 400 plus
Lesson
Technical specifications
Roche Diagnostics
8-16 Training Manual · Version 1.3
COBAS INTEGRA 400 plus ISE module
Lesson
After replacing electrodes on the ISE module, the “Electrode Service” action will be
performed automatically from the system.
The slope ranges for newly installed electrodes should be in the upper half of the
recommended electrode slope range.
This section describes all the ISE flags generated by the COBAS INTEGRA 400
plus, their associated error messages, and the corresponding user actions.
ISE flags, like other flags, are automatically generated with results when the
system detects a problem or a potential problem. When a flag is generated, it is
displayed together with the result in the Results work area. When you print a
result, the flag is also printed.
Flags and error messages Some ISE flags trigger error messages if they appear in a consecutive sequence.
A flag counter monitors the number of consecutive flags and triggers an error
message if the counter limit is reached. Each flag has its own counter and
counter limit as listed in “Flags and user actions” on page 8-19.
If a single ISE measurement does not generate a particular flag, the flag
counter is reset to zero.
With a single flag, repeat the measurement or the calibration. An error
message indicates a more persistent error requiring further action, for
example, performing service actions.
Flag priority If the conditions in the ISE module are such that multiple flags could be
generated for a single ISE measurement, only the flag with the highest priority
is displayed (or printed) with the result. The lower the number, the higher the
priority. The priority of each flag is given in the flag description. All other
flags with lower priority are shown in the result details.
Results without flags are automatically within the reference range and can be
considered to be error-free.
Flags and result handling When a flag occurs, processing is dependent upon result handling, which is
defined in Configuration / Result Handling / Results. You can check the
details held in result handling to review what your system does when it
generates specific flags.
Roche Diagnostics
Training Manual · Version 1.3 8-17
ISE module COBAS INTEGRA 400 plus
Lesson
The system action can be different for calibrations, controls and samples.
Roche Diagnostics
8-18 Training Manual · Version 1.3
COBAS INTEGRA 400 plus ISE module
Lesson
Where a flag description gives a list of recommended actions, work through each step
in turn until you have solved the problem. Proceed to the next step only after you
have completed the previous one.
List of flags The following table lists the flags in alphabetical order:
Roche Diagnostics
Training Manual · Version 1.3 8-19
ISE module COBAS INTEGRA 400 plus
Lesson
Messages number format When a repeated flag generates a message, the message number has the
format: aa.bbbb.cc.ddd.xxx as shown in the table above. You can uniquely
identify a message by the second (cc) and the third (ddd) groups of digits.
For example, in the message 14.3248.08.012.xxx, the digits 08.012 identify the
message; xxx means “don’t care”, that is, these digits are not significant.
If a message box is displayed, you can get detailed information by clicking
Help.
Terminology The following terminology is used in the flag descriptions that follow:
FLUID
Any liquid (sample, control, calibrator, or other solution) that is introduced
into the ISE tower.
ISECAL
ISE Calibrator Direct or ISE Calibrator Indirect/Urine.
SEG
A segment of fluid that is drawn past the fluid sensor and therefore, past the
electrodes. Fluid segments are separated by air segments.
Flags and service actions Some user actions for flags include performing service actions.
Roche Diagnostics
8-20 Training Manual · Version 1.3
COBAS INTEGRA 400 plus ISE module
Lesson
Flag descriptions
AIR FLUID
Message 14.3248.0814.3248.08.023.xxx
Unable to position the segment. Check sample flow.
IND/URINE: Check mixing strength (probably too strong). Check ISE-tower
and tubing to the electrode block for clogs, leakage. Clean tower and replace
tubes if necessary.
AIR ISECAL
Message 14.3248.08.030.xxx
Unable to position the segment. Check the presence and the volume of ISE
CAL bottles. Check tubing at CAL bottles for clogs/leaks/bends. Replace if
necessary. Perform Prime ISE CAL after the replacement of tubes.
Roche Diagnostics
Training Manual · Version 1.3 8-21
ISE module COBAS INTEGRA 400 plus
Lesson
ISE UNSTAB
Meaning, cause, and action depend on the message ID, which are divided into
two groups:
o 14.3248.08.031.xxx through 14.3248.08.038.xxx
o 14.3248.08.018.xxx (leakage)
Meaning The signal from the electrode(s) was not stable during the measurement.
Possible cause The ISE measurements (mV Values) are unstable because:
o There are air bubbles in the measuring segment.
o The concentration of electrolyte in the sample is too low (for example,
dialyzed samples).
o The pH of the sample is too low (for example, pH < 5.5).
o One or more O-rings are missing or damaged.
o The electrodes have not been serviced.
o The expiration date of the electrode has passed or the electrode is
damaged.
o The ISE Reference Electrolyte tubing is blocked or leaking.
o The floater of the ISE Reference Electrolyte bottle is blocked.
Roche Diagnostics
8-22 Training Manual · Version 1.3
COBAS INTEGRA 400 plus ISE module
Lesson
Possible cause The ISE measurements (mV Values) are unstable because:
o One or more O-rings are missing or damaged.
o The electrodes and/or the electrode block are not dry.
Roche Diagnostics
Training Manual · Version 1.3 8-23
ISE module COBAS INTEGRA 400 plus
Lesson
NO FLUID
Message 14.3248.08.010.xxx
No fluid at sensor 1: Check the sample flow. Check the ISE tower and tubing
to the electrode block for clogs, leakage and correct fit. Clean tower and
replace tubes if necessary.
14.3248.08.011.xxx
No fluid at sensor 2: Check the sample flow. Check the ISE tower and tubing
to the electrode block for clogs, leakage and correct fit. Clean tower and
replace tubes if necessary.
Possible cause The fluid sensors could not detect any liquid because:
o The liquid was not pipetted.
o The ISE tower is clogged.
o The ISE module tubing is blocked.
o Fluid sensor 1 or 2 is defective.
Roche Diagnostics
8-24 Training Manual · Version 1.3
COBAS INTEGRA 400 plus ISE module
Lesson
NO ISECAL
Message 14.3248.08.027.xxx
No ISE calibrator detected.
OUT OF RNG
Message None
Possible cause Electrode slope out of range. This flag appears with calibrations because:
o There are problems with the ISE solutions on the ISE rack.
o There are problems with the electrodes or an improperly serviced ISE
module.
o The ISE Reference Electrolyte tubing is blocked or leaking.
o The floater of the ISE Reference Electrolyte bottle is blocked.
o The dosing from the sample probe is not accurate.
Roche Diagnostics
Training Manual · Version 1.3 8-25
ISE module COBAS INTEGRA 400 plus
Lesson
SEG FLUID
Message 14.3248.08.012.xxx
End of fluid segment not detected. Check the ISE tower and tubing of the
electrode block for clogs, leakage and correct it. Clean tower and replace tubes
if necessary.
Possible cause The end of the sample segment was not detected. It takes too long for a sample
segment to reach the electrodes because:
o The ISE tower is clogged.
o The ISE module tubing is leaking or blocked.
Roche Diagnostics
8-26 Training Manual · Version 1.3
COBAS INTEGRA 400 plus ISE module
Lesson
SEG ISECAL
Message 14.3248.08.028.xxx
End of calibrator segment not detected. Check presence and volume of ISE
CAL bottles. Check tubing of CAL bottles for leaks and bends. Replace if
necessary. Perform Prime ISE Cal.
Possible cause The end of the calibrator segment was not detected. It takes too long for a
calibrator segment to reach the electrodes because:
o The ISE module tubing is leaking or blocked.
o The ISE distribution block is leaking or blocked.
SOL 1 F DEV
Message None
Possible cause Deviation of Sol 1 Factor. This flag occurs with calibrations because:
o The dosing from the sample probe is not accurate.
o The ISE tower is blocked.
o There may be problems with the ISE module tubing, the electrodes, or an
improperly serviced ISE module.
Roche Diagnostics
Training Manual · Version 1.3 8-27
ISE module COBAS INTEGRA 400 plus
Lesson
<TEST RNG
Message None
Possible cause The actual concentration in the sample is below the test range
>TEST RNG
Message None
Possible cause The actual concentration in the sample exceeds the test range.
Roche Diagnostics
8-28 Training Manual · Version 1.3
COBAS INTEGRA 400 plus ISE module
Lesson
Poor accuracy
Results are reproducible but do not match the known values.
1 Perform the service action Clean ISE tower automatically or Clean ISE
tower manually.
2 Contact Roche Service.
Roche Diagnostics
Training Manual · Version 1.3 8-29
ISE module COBAS INTEGRA 400 plus
Lesson
a All electrodes:
Roche Diagnostics
8-30 Training Manual · Version 1.3
COBAS INTEGRA 400 plus ISE module
Lesson
1 Perform the service action Clean ISE tower automatically or Clean ISE
tower manually.
2 Contact Roche Service.
Check the expiration date of all ISE solutions and replace those which have
expired.
Check the expiration and replacement dates of the ISE Reference Electrolyte
and the reference electrode, and replace if necessary.
Roche Diagnostics
Training Manual · Version 1.3 8-31
ISE module COBAS INTEGRA 400 plus
Lesson
Roche Diagnostics
8-32 Training Manual · Version 1.3
COBAS INTEGRA 400 plus ISE module
Exercises
Exercises
Preparing the ISE module 1. Load the ISE Direct tests in Configuration / Tests.
2. Assign the control Precinorm to the tests.
3. Enter the lot number of ISE Solution 1, 2, and 3.
4. Define the position of ISE Solution 1, 2, and 3, ISE Etcher, ISE
Deproteinizer, and ISE Activator on the ISE rack in Configuration / Lab /
Reserve Positions.
5. Select the electrode combination in use (Na, Cl, K, Li) in Configuration /
General / ISE.
6. Enable the ISE module and the electrodes in the Status work area on the
ISE tab.
7. Place the electrodes in the electrode block (faraday cage) on the ISE
module according to electrode assignment defined in Configuration /
General / ISE.
8. Place the ISE Calibrator Direct, ISE Calibrator Indirect/Urine, and ISE
Reference Electrolyte onto the module
9. Place ISE Solution 1, 2, and 3, ISE Etcher, ISE Activator, and ISE
Deproteinizer onto the ISE rack.
Ordering ISE tests Enter 2 patients and request a sodium and potassium determination (ISE
direct mode) on your samples.
Roche Diagnostics
Training Manual · Version 1.3 8-33
ISE module COBAS INTEGRA 400 plus
Exercises
Working with results 1. What are the calculated slopes for the different electrolytes?
NA-D:
................................................................................................................
K-D:
................................................................................................................
CL-D:
................................................................................................................
LI-D:
................................................................................................................
2. List the different flags obtained on your calibration results, take the
appropriate actions, and rerun the ISE calibration.
................................................................................................................
................................................................................................................
................................................................................................................
3. Print the NA-D raw data of your patient results.
4. Accept the patient results and print the statistics for NA-D and K-D for
both patients.
5. Print the Final Reports for both patients.
6. When the system is in Ready status, go to the Service work area and
perform the service action Electrode service.
Roche Diagnostics
8-34 Training Manual · Version 1.3
COBAS INTEGRA 400 plus ISE module
Questions
Questions
1. What electrolytes can you measure with the ISE module?
................................................................................................................
2. In which mode are ISE determinations on serum and plasma samples
performed?
................................................................................................................
3. In which mode are ISE determinations on urine samples performed?
................................................................................................................
4. Where is the ISE Reference Electrolyte bottle located?
................................................................................................................
5. How are the samples for ISE measurements pipetted?
................................................................................................................
6. Where can you request an ISE calibration?
................................................................................................................
7. How many ISE solutions are on the ISE rack when all electrodes are
installed?
................................................................................................................
8. Where can you define the positions for the solutions on the ISE rack?
................................................................................................................
9. In which slot do you place the ISE rack?
................................................................................................................
10.When must the ISE Activator be replaced?
................................................................................................................
................................................................................................................
................................................................................................................
11.Which ISE service actions and procedures could be automatically
performed during Begin of Day?
................................................................................................................
................................................................................................................
................................................................................................................
12.In which ISE mode should pediatric samples be measured? What is the
required sample volume?
................................................................................................................
13.What is the required sample volume for direct ISE measurements?
................................................................................................................
14.What is the required sample volume for indirect ISE measurements?
................................................................................................................
Roche Diagnostics
Training Manual · Version 1.3 8-35
ISE module COBAS INTEGRA 400 plus
Answers
Answers
1. What electrolytes can you measure with the ISE module?
Sodium, potassium, chloride, and lithium
2. In which mode are ISE determinations on serum and plasma samples
performed?
Direct or indirect mode
3. In which mode are ISE determinations on urine samples performed?
Urine mode 1/6 Dilution
4. Where is the ISE Reference Electrolyte bottle located?
ISE module
5. How are the samples for ISE measurements pipetted?
Samples for ISE measurements are pipetted by the sample transfer arm into
the ISE tower.
6. Where can you request an ISE calibration?
Calibration tab in the Orders work area
7. How many ISE Solutions are on the ISE rack when all electrodes are
installed?
ISE Solution 1, 2, and 3
8. Where can you define the positions for the solutions on the ISE rack?
In Configuration / Lab / Reserve Positions
9. In which slot do you place the ISE rack?
Slot O.
10.When must the ISE Activator be replaced?
Every 4 days
11.Which ISE service actions and procedures could be automatically
performed during Begin of Day?
Initialize ISE module, Electrode service (deproteinizing, etching and
activating procedures), Activate electrodes, Prime ISE calibrators, Clean ISE
tower automatically and Condition ISE tubing
12.In which ISE mode should pediatric samples be measured? What is the
required sample volume?
Indirect mode, 20 µL
13.What is the required sample volume for direct ISE measurements?
Direct ISE measurements use 97 µL of sample
14.What is the required sample volume for indirect ISE measurements?
Indirect ISE measurements use 20 µL of sample
Roche Diagnostics
8-36 Training Manual · Version 1.3
COBAS INTEGRA 400 plus Questions and answers
Roche Diagnostics
Training Manual · Version 1.3 9-1
Questions and answers COBAS INTEGRA 400 plus
Questions
Questions
Hardware overview
Roche Diagnostics
9-2 Training Manual · Version 1.3
COBAS INTEGRA 400 plus Questions and answers
Questions
Review questions
1. What are the different temperatures on the COBAS INTEGRA 400 plus?
....................................................................................................................
2. How many cassettes can be on the system at the same time?
....................................................................................................................
3. Which kind of Electrolytes can be measured on the ISE module?
....................................................................................................................
4. How many probes are available on the COBAS INTEGRA 400 plus?
....................................................................................................................
5. What is the cycle time on the COBAS INTEGRA 400 plus?
....................................................................................................................
6. How many tubes can be placed on a sample rack?
....................................................................................................................
7. Can you mix different kinds of tubes on the same rack?
....................................................................................................................
8. How is a cassette identified?
....................................................................................................................
9. How many wavelengths are used on the absorbance photometer?
....................................................................................................................
10.Which operating system is used on the COBAS INTEGRA 400 plus?
....................................................................................................................
11.What are the 3 measuring principles of the COBAS INTEGRA 400 plus?
....................................................................................................................
12.What is the typical sample volume?
....................................................................................................................
13.How are granulate cassettes reconstituted?
....................................................................................................................
14.What is the cuvette reservoir capacity?
....................................................................................................................
15.How many cuvettes can be loaded on the analyzer rotor?
....................................................................................................................
16.What are the water requirements?
....................................................................................................................
17.How much water does the COBAS INTEGRA 400 plus consume in the
operating mode?
....................................................................................................................
18.When can a rack be accessed or removed from the platform?
....................................................................................................................
19.What information is available on the cassette barcode label?
....................................................................................................................
Roche Diagnostics
Training Manual · Version 1.3 9-3
Questions and answers COBAS INTEGRA 400 plus
Questions
Test run
Review questions
1. List the 3 ways to log on the system?
....................................................................................................................
2. How can you leave a message to your colleagues?
....................................................................................................................
3. What is the meaning of the yellow color of a cassette status item?
....................................................................................................................
4. How do you know that Service actions are due?
...................................................................................................................
5. How can you find out the lot number and the expiry date of my cassettes
on board?
....................................................................................................................
6. List a few reasons why a test can be blocked?
....................................................................................................................
....................................................................................................................
....................................................................................................................
....................................................................................................................
7. What happens when the cuvette reservoir is empty?
....................................................................................................................
8. List the different solutions located on the ISE rack.
....................................................................................................................
....................................................................................................................
....................................................................................................................
9. How can you access Help?
....................................................................................................................
....................................................................................................................
10.When is the Service icon red?
....................................................................................................................
....................................................................................................................
Roche Diagnostics
9-4 Training Manual · Version 1.3
COBAS INTEGRA 400 plus Questions and answers
Answers
Answers
Hardware overview
System
A J
B K
L
M
C N
O
E
P
Q
F
R
G
H
S
Roche Diagnostics
Training Manual · Version 1.3 9-5
Questions and answers COBAS INTEGRA 400 plus
Answers
Fluid system
A
G
B
H
C I
Roche Diagnostics
9-6 Training Manual · Version 1.3
COBAS INTEGRA 400 plus Questions and answers
Answers
Cuvette system
Roche Diagnostics
Training Manual · Version 1.3 9-7
Questions and answers COBAS INTEGRA 400 plus
Answers
Rack platform
.
A D
A
B D
B C
A Cassette area (cooled to 10 - 15 °C). Slots A through H are for cassette racks.
B Slot I in the cassette area (also cooled) is for sample racks—typically used for
calibrators and controls.
C Slot O is for the ISE rack.
D Sample area. Slots I through N are for sample racks.
Rack system
D
A
B E
C
F
Roche Diagnostics
9-8 Training Manual · Version 1.3
COBAS INTEGRA 400 plus Questions and answers
Answers
Sample/Cal/QC racks
C
A D
F H
G G
Roche Diagnostics
Training Manual · Version 1.3 9-9
Questions and answers COBAS INTEGRA 400 plus
Answers
Transfer system
D E
A
B
A Transfer head cover D Cassette area initialization post and protective sleeve
(not visible in the main system part of the picture)
B Transfer arm
E Sample area initialization post
C ISE initialization post
F Wash station initialization post
(not visible in the main system part of the picture)
Roche Diagnostics
9-10 Training Manual · Version 1.3
COBAS INTEGRA 400 plus Questions and answers
Answers
Transfer head
B E
Roche Diagnostics
Training Manual · Version 1.3 9-11
Questions and answers COBAS INTEGRA 400 plus
Answers
Analyzer module
A
E
B
F
C
G
H
D
Roche Diagnostics
9-12 Training Manual · Version 1.3
COBAS INTEGRA 400 plus Questions and answers
Answers
ISE module
A
D
B
E
C
F
G
Roche Diagnostics
Training Manual · Version 1.3 9-13
Questions and answers COBAS INTEGRA 400 plus
Answers
ISE rack
A
B
C
D
Rackcode 014
2
A
3
E
4
5
6
7
8
IS
E
14
C
O
B
A
S
Roche Diagnostics
9-14 Training Manual · Version 1.3
COBAS INTEGRA 400 plus Questions and answers
Answers
Roche Diagnostics
Training Manual · Version 1.3 9-15
Questions and answers COBAS INTEGRA 400 plus
Answers
Review answers
1. What are the different temperatures on the COBAS INTEGRA 400 plus?
10-15 °C on the reagent platform.
Room temperature for the sample platform.
37 °C in the analyzer chamber.
2. How many cassettes can be on the system at the same time?
32 (4 cassettes per rack - 8 slots A to H).
3. Which kind of Electrolytes can be measured on the ISE module?
Sodium, Potassium, Chloride and Lithium
4. How many probes are available on the COBAS INTEGRA 400 plus?
Two probes on one transfer arm.
5. What is the cycle time on the COBAS INTEGRA 400 plus?
10.6 seconds.
6. How many tubes can be placed on a sample rack?
15 tubes, primary or secondary.
7. Can you mix different kinds of tubes on the same rack?
No.
8. How is a cassette identified?
By a barcode scanner.
9. How many wavelengths are used on the absorbance photometer?
Twelve different wavelengths are measured.
10.Which operating system is used on the COBAS INTEGRA 400 plus?
Windows XP
11.What are the 4 measuring principles of the COBAS INTEGRA 400 plus?
Absorbance photometry.
Fluorescence polarimetry.
Turbidimetry.
Potentiometry.
12.What is the typical sample volume
o 2-10 µL
o 20 µL(ISE, indirect and urine mode)
o 97 µL (ISE, direct mode)
13.How are the granulate cassettes reconstituted?
Prepierce the aluminum lid, load the reagent on board, reconstitution is done
automatically by the system, remove the cassette from the system and mix the
reagent on the external mixer for 10 minutes.
14.What is the cuvette reservoir capacity?
1400, refilling possible during operation.
Roche Diagnostics
9-16 Training Manual · Version 1.3
COBAS INTEGRA 400 plus Questions and answers
Answers
Roche Diagnostics
Training Manual · Version 1.3 9-17
Questions and answers COBAS INTEGRA 400 plus
Answers
Test run
Review answers
1. List the 3 ways to log on the system?
o In the menu bar, choose Tools > Log on/off.
o Press Shift+F3 on your keyboard.
o Double-click None at the bottom of the screen.
2. How can you leave a message to your colleagues?
By using the Memo Pad (Click on the icon or select Window, Memo Pad in the
menu bar or press Shift F7).
3. What is the meaning of the yellow color of a cassette status item?
The cassette is expired, almost empty or requires mixing.
4. How do you know that Service actions are due?
The Service icon is yellow.
5. How can you find out lot number and the expiry date of my cassettes on
board?
In the Status work area, click the Cassette tab and double-click a cassette.
6. List a few reasons why a test can be blocked?
The cassette is missing, empty, or requires mixing, the rack is not on board, the
diluent is missing, the sample cup is empty, the calibrator is missing, the test is
disabled, the Quality Control is not defined, the Cleaner is missing,
calibration is required.
7. What happens when the cuvette reservoir is empty?
A red cuvette icon will replace the Status icon.
8. List the different solutions located on the ISE rack.
ISE Deproteinizer, ISE Etcher, ISE Activator, ISE Solutions 1, 2 and 3, special
diluents.
9. How can you access Help?
By pressing F1 on the keyboard.
10.When is the Service icon red?
The service icon is red when the backup database function has an elapsed
time higher than 120%.
Roche Diagnostics
9-18 Training Manual · Version 1.3
Diagnostics
DAT
- Drugs of abusing testing -
Sanela Hatipovic
Global Systems Support RIC Version 3.0 Operator Training COBAS Integra 400 plus
What is Drug Abuse Testing (DAT)?
Diagnostics
DAT is measuring the concentration of drugs in urine of
licit and illicit drugs.
Global Systems Support RIC Version 3.0 Operator Training COBAS Integra 400 plus
Overview of licit and illicit
Diagnostics
CANNABIS HALLUCINOGENE STIMULANTS NARCOTICS
Black market
MMDA
Alcoholic drinks
beer, wine,
spirits e.g. vodka
Betel
tobacco
Purin-drugs
coffee, tea, cacao, Sleeping-inducing Antidepressants Sniffing
coke Stimulants Analgetics
drug Benzodiazepines, Barbiturates (Sedativa) substances
Market
Alcoholic drinks,
tobacco, etc. Medicine Solvents
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Classification of drugs of abuse
Diagnostics
Central nervous system (CNS) effects
Diagnostics
Opiates Category: Narcotics
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Overview of licit and illicit
Diagnostics
Cannabis Category: Hallucinogens
• The cover term "cannabinoids" includes approximately
60 structurally related constituents of cannabis.
• Tetracannabinol (THC)
• Cannabidiol (CBD)
• Cannabinol (CBN).
Global Systems Support RIC Version 3.0 Operator Training COBAS Integra 400 plus
Overview of licit and illicit
Diagnostics
Cannabis Category: Hallucinogens
• Hashish
resin of flowers clusters.
THC: 2 to 10 %.
• Marijuana
Air-dried leaf, flower, stem parts.
• Hashish oil
Extraction with organic solvents
THC: 10 to 30 (60) %
Global Systems Support RIC Version 3.0 Operator Training COBAS Integra 400 plus
Overview of licit and illicit
Diagnostics
Cocaine Category: Stimulants
Global Systems Support RIC Version 3.0 Operator Training COBAS Integra 400 plus
Overview of licit and illicit
Diagnostics
Cocaine Category: Stimulants
Street cocaine whitish powder
The purity of cocaine is generally 70 to 85 %,
that of the end-user 25 %.
Global Systems Support RIC Version 3.0 Operator Training COBAS Integra 400 plus
Overview of licit and illicit
Diagnostics
Cocaine Category: Stimulants
Global Systems Support RIC Version 3.0 Operator Training COBAS Integra 400 plus
Overview of licit and illicit
Diagnostics
Benzodiazepines Category: Antidepressants
Barbiturates
are the biggest and most commonly used group of synthetic sedatives and
hypnotic.
Global Systems Support RIC Version 3.0 Operator Training COBAS Integra 400 plus
Overview of licit and illicit
Diagnostics
Designer drugs Category: Stimulants
Global Systems Support RIC Version 3.0 Operator Training COBAS Integra 400 plus
Overview of licit and illicit
Diagnostics
Amphetamines Category: Stimulants
• Metamphetamines
Street name: "speed", "meth", "crank"
• Phenetylamines and methoxyamphetamines
Street name: "tranquility" (DOM) and "golden eagle" (DOB)
Global Systems Support RIC Version 3.0 Operator Training COBAS Integra 400 plus
Drug Pharmacology
Diagnostics
The time it takes for a drug to appear in the urine depends on
• administration route
• time of absorption into the blood stream
• distribution place in the human body
• time of metabolism and route of excretion
Global Systems Support RIC Version 3.0 Operator Training COBAS Integra 400 plus
Drug Pharmacology
Diagnostics
Other factors that contribute to whether a drug can be found in
urine include the
• potency of the drug
• capability of genetic metabolism of the individual
• individuals health
• amount of liquid consumed prior to specimen
collection
• time since last administration
Global Systems Support RIC Version 3.0 Operator Training COBAS Integra 400 plus
Specimens for DAT assays
Diagnostics
Adulteration
Definition
Global Systems Support RIC Version 3.0 Operator Training COBAS Integra 400 plus
Specimens for DAT assays
Diagnostics
Adulteration
Methods of adulteration
•Specimen substitution
•Specimen dilution
- adding water
- ingestion of substances that produce diuresis
•In vivo adulterants
•In vitro adulterants
Global Systems Support RIC Version 3.0 Operator Training COBAS Integra 400 plus
Specimens for DAT assays
Diagnostics
Adulteration
Confirmation of adulteration
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Specimens for DAT assays
Diagnostics
Adulteration
Global Systems Support RIC Version 3.0 Operator Training COBAS Integra 400 plus
Diagnostics
Online DAT Test Application - Cut off
Definition
• A cut-off concentration is the administrative ”breakpoint”
used to distinguish positive and negative specimens.
• Values are defined by SAMHSA:
(Substance Abuse Mental Health Services Administration)
• Results equal or above this value are reported as
positive
• Results below are reported as
negative
Global Systems Support RIC Version 3.0 Operator Training COBAS Integra 400 plus
Diagnostics
Calibration Mode
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Diagnostics
ONLINE DAT® II Calibrators
Global Systems Support RIC Version 3.0 Operator Training COBAS Integra 400 plus
Diagnostics
ONLINE DAT® II Calibrators
Global Systems Support RIC Version 3.0 Operator Training COBAS Integra 400 plus
Diagnostics
ONLINE DAT® II Calibrators
Global Systems Support RIC Version 3.0 Operator Training COBAS Integra 400 plus
Diagnostics
ONLINE DAT® II Calibrators
Global Systems Support RIC Version 3.0 Operator Training COBAS Integra 400 plus
ONLINE DAT® II Calibrators
Diagnostics
Preciset DAT Plus I Preciset DAT Plus II C.f.a.s. DAT Qualitative Plus
03304671190 03304680190 03304698
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ONLINE DAT® II Controls
Diagnostics
Global Systems Support RIC Version 3.0 Operator Training COBAS Integra 400 plus
Diagnostics
Methods used for the determination of drugs
Global Systems Support RIC Version 3.0 Operator Training COBAS Integra 400 plus
Diagnostics
Methods used for the determination of drugs
KIMS (Kinetic interaction of microparticles in solution)
ONLINE II Reagents
at this time:
Global Systems Support RIC Version 3.0 Operator Training COBAS Integra 400 plus
Diagnostics
Methods used for the determination of drugs
KIMS (Kinetic interaction of microparticles in solution)
Global Systems Support RIC Version 3.0 Operator Training COBAS Integra 400 plus
Diagnostics
Methods used for the determination of drugs
KIMS (Kinetic interaction of microparticles in solution)
Anti-drug antibody
Global Systems Support RIC Version 3.0 Operator Training COBAS Integra 400 plus
Diagnostics
Methods used for the determination of drugs
KIMS (Kinetic interaction of microparticles in solution)
Global Systems Support RIC Version 3.0 Operator Training COBAS Integra 400 plus
Diagnostics
Methods used for the determination of drugs
KIMS (Kinetic interaction of microparticles in solution)
+ +
Global Systems Support RIC Version 3.0 Operator Training COBAS Integra 400 plus
Diagnostics
Methods used for the determination of drugs
KIMS (Kinetic interaction of microparticles in solution)
Drug conjugate
Global Systems Support RIC Version 3.0 Operator Training COBAS Integra 400 plus
Diagnostics
Methods used for the determination of drugs
KIMS (Kinetic interaction of microparticles in solution)
Online reagents 2nd generation
Positive sample
Drug in the
sample
Morphine
Conjugate
R2 (SR) = bottle 2
Conjugate reagent
R1 = bottle 1
Antibody/ Microparticle
Global Systems Support RIC Version 3.0 Operator Training COBAS Integra 400 plus
Diagnostics
Methods used for the determination of drugs
KIMS (Kinetic interaction of microparticles in solution)
Online reagents 2nd generation
negative sample
R2 (SR) = bottle 2
R1 = bottle 1
Conjugate reagent
Antibody/ Microparticle
Global Systems Support RIC Version 3.0 Operator Training COBAS Integra 400 plus
Diagnostics
Methods used for the determination of drugs
KIMS (Kinetic interaction of microparticles in solution)
Global Systems Support RIC Version 3.0 Operator Training COBAS Integra 400 plus
Diagnostics
Methods used for the determination of drugs
KIMS (Kinetic interaction of microparticles in solution)
Global Systems Support RIC Version 3.0 Operator Training COBAS Integra 400 plus
Diagnostics
ONLINE DAT I
Reagents
R1: Vial A: Sample Diluent
Buffer containing stabilizer and preservative
Reaction mode: R1 - R2 - S – SR
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Diagnostics
ONLINE DAT II
Reagents
Reaction mode: R1 - S - SR
Global Systems Support RIC Version 3.0 Operator Training COBAS Integra 400 plus
Diagnostics
ONLINE DAT II Reagents:
Optimized for all Roche systems, every ONLINE DAT II reagent relies
on proven KIMS technology to deliver:
Global Systems Support RIC Version 3.0 Operator Training COBAS Integra 400 plus
Diagnostics
ONLINE DAT II Reagents:
Global Systems Support RIC Version 3.0 Operator Training COBAS Integra 400 plus
Diagnostics
Specimens for DAT assays
Global Systems Support RIC Version 3.0 Operator Training COBAS Integra 400 plus
Diagnostics
Online DAT Test Application - Reagent
Handling
Preparation
Generation I / II
New punctured cassettes must be mixed for 1 minute.
Integra 700/800 automatically mixing
Global Systems Support RIC Version 3.0 Operator Training COBAS Integra 400 plus
Diagnostics
Online DAT Test Application – Calibration
Qualitative assay
Global Systems Support RIC Version 3.0 Operator Training COBAS Integra 400 plus
Diagnostics
Online DAT Test Application – Calibration
Qualitative assay
Global Systems Support RIC Version 3.0 Operator Training COBAS Integra 400 plus
Diagnostics
Online DAT Test Application – Calibration
Semiquantitative assay
Global Systems Support RIC Version 3.0 Operator Training COBAS Integra 400 plus
Diagnostics
Online DAT Test Application - Controls
Qualitative assay Example: Cocaine
COCA Q Qualitative test Limit control
Global Systems Support RIC Version 3.0 Operator Training COBAS Integra 400 plus
Diagnostics
Online DAT Test Application - Controls
Semiquantitative assay Example: Cocaine
COCA
Assigned value (AS): 450
Permissible Deviation (PD) 149 Positive
Rule: control
bottle value 450 – cut off 300 = 150 permissible dev.
Global Systems Support RIC Version 3.0 Operator Training COBAS Integra 400 plus
Diagnostics
Online DAT Result Interpretation
Global Systems Support RIC Version 3.0 Operator Training COBAS Integra 400 plus
Diagnostics
Online DAT Result Interpretation
Global Systems Support RIC Version 3.0 Operator Training COBAS Integra 400 plus
THC Calibrators:
Diagnostics
• Five calibrators available for THC
• Three assays with different cut-off levels:
• THC20, THC50 and THC100 (cut-off at 100 ng/ml)
• Each assay uses only four of five standards
• When not in use, all calibrators should be stored at 2-8°C in glass
bottles.
Samples:
• THC and its metabolites may adsorb onto plastics used for sample
collection
• For long term storage use glass tubes
• Or COBAS Cups with at least 500µl and test within 2 hours
Global Systems Support RIC Version 3.0 Operator Training COBAS Integra 400 plus
Ethanol Calibrators:
Diagnostics
• Enzymatic reaction
• Calibrator: Roche Ammonia/Ethanol/CO2:
• Ready to use
• Stable until expiration date
• Aqueous based
• When opened, stable 1 month at 2-8°C
Global Systems Support RIC Version 3.0 Operator Training COBAS Integra 400 plus
Ethanol Controls:
Diagnostics
• Control Roche Ammonia/Ethanol/CO2:
• Ready to use
• Aqueous based
• Stable until expiration date
• When opened, stable 1 month at 2-8°C
Global Systems Support RIC Version 3.0 Operator Training COBAS Integra 400 plus
Diagnostics
Global Systems Support RIC Version 3.0 Operator Training COBAS Integra 400 plus
r
Diagnostics
Diagnostics
TDM
- Therapeutic drug monitoring -
Sanela Hatipovic
Global Systems Support RIC Version 3.0 Operator Training COBAS Integra 400 plus
Definition
Diagnostics
Therapeutic Drug Monitoring
Global Systems Support RIC Version 3.0 Operator Training COBAS Integra 400 plus
Considerations Before Drug Treatment
Diagnostics
• Which Drug Do I Use?
• How Frequently?
Global Systems Support RIC Version 3.0 Operator Training COBAS Integra 400 plus
Phases of Drug Therapy
Diagnostics
• Pharmacokinetics - Action of the Body on the Drug.
• Pharmacodynamics - Action of the Drug on the Body.
• Key Concept:
Everyone is Different
Metabolism is Altered by Illness and
Metabolism is Altered by Overdose
Global Systems Support RIC Version 3.0 Operator Training COBAS Integra 400 plus
Definition
Diagnostics
Pharmacokinetic
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Pharmakocinetic
Diagnostics
drug changes with multiple identical doses
Global Systems Support RIC Version 3.0 Operator Training COBAS Integra 400 plus
Pharmakocinetic
Diagnostics
drug changes within the steady state between peak and trough
Global Systems Support RIC Version 3.0 Operator Training COBAS Integra 400 plus
Therapeutic range
Diagnostics
Above range
toxic side
Below range
therapy most
likely ineffective
Global Systems Support RIC Version 3.0 Operator Training COBAS Integra 400 plus
Therapeutic range
Diagnostics
• Measurable concentration ranges collectively define
a therapeutic range.
Global Systems Support RIC Version 3.0 Operator Training COBAS Integra 400 plus
Therapeutic range
Diagnostics
• Through blood concentration
the lowest concentration achieved just before the next dose.
Global Systems Support RIC Version 3.0 Operator Training COBAS Integra 400 plus
Drug families involved in TDM
Diagnostics
• Antibiotics
• Anti-convulsants
• Anti-astmatics
• Cardiac agents
• Immunosuppressive agents
Global Systems Support RIC Version 3.0 Operator Training COBAS Integra 400 plus
Antibiotics
Diagnostics
• Amikacin
• Gentamicin
• Tobramycin
• [Kanamycin]
• [Netilmycin]
• [Streptomycin]
• Vancomycin
• [Chloramphenocol]
Global Systems Support RIC Version 3.0 Operator Training COBAS Integra 400 plus
Anti-convulsants - Anti-epileptics
Diagnostics
• Carbamazepine
• Phenobarbital
• Primidone
• Phenytoin (Free & Total)
• Valproic Acid (Free & Total)
• [Ethosuximide]
Global Systems Support RIC Version 3.0 Operator Training COBAS Integra 400 plus
Anti-asthmatics
Diagnostics
• Theophylline
• Caffeine
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Cardiac agents
Diagnostics
Antiarrhythmics Cardiac Glycosides
• Quinidine Digoxin
• Lidocaine Digitoxin
• Procainamide
• N-acetylprocainamide (NAPA)
Global Systems Support RIC Version 3.0 Operator Training COBAS Integra 400 plus
Immunosupressants
Diagnostics
• Cyclosporine
• Mycophenolate
• [Tacrolimus (FK-506) 2008]
• [Sirolimus (Rapamycin)2008]
Global Systems Support RIC Version 3.0 Operator Training COBAS Integra 400 plus
Analgesic & anti-inflammatory agents
Diagnostics
• Acetaminophen
• Salicylic Acid
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Presence of drugs in serum
Diagnostics
• Drugs as ”free” or bound to serum proteins.
Global Systems Support RIC Version 3.0 Operator Training COBAS Integra 400 plus
Presence of drugs in serum
Diagnostics
• Various factors affect protein binding:
» Age
» pH
» Pathological changes
» Displacement by other drugs, etc.
Global Systems Support RIC Version 3.0 Operator Training COBAS Integra 400 plus
Analytical and practical requirements
Diagnostics
• Accuracy and reproducibility.
• Inform medical staff about therapeutic range and toxic
concentration ranges, required sample volume and collection
tube specifications.
• Guidelines should be available of ideal sample scheduling for
each individual drug monitored. Steady state trough
concentrations are most desirable.
• Timing of blood sampling
Global Systems Support RIC Version 3.0 Operator Training COBAS Integra 400 plus
TDM Technologies
Diagnostics
• HPLC High Performance Liquid Chromatography
• EMIT Enzyme Multiplied Immunoassay
• CEDIA Cloned Enzyme Donor Immunoassay
• FPIA Fluorescent Labeled Immunoassay
• KIMS Kinetic Interaction of Microparticles in Solution
• Enzymatic
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TDM Technologies
Diagnostics
TDM Testing Menu
EMIT: CSA
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TDM Technologies
Diagnostics
Enzymatic Reaction
ACETA, SAL
Enzyme, cofactor(s)
1. Substrate Product 1 + Product 2
Catalyst(s)
2. Product 1 Color Product
Diagnostics
Competitive Binding
The labelled
antigens bind
The antigens
to the remaining
bind to the sites on the
antibodies antibodies
Blankreading Testreading
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Diagnostics
Test Principle
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Diagnostics
FP Technology Overview
Fluorescence Polarization
is defined as the measurement of change in the angle of
polarized light emitted by a fluorescent molecule.
Global Systems Support RIC Version 3.0 Operator Training COBAS Integra 400 plus
Diagnostics
TDM Technologies
FPIA - Fluorescent labeled immunoassay
Polarized Light
Fl* Fl*
~ 100 ns Rotation ~ 1 ns Rotation
Free Tracer
Antibody:Tracer
Complex
Polarization Light is
Retained Depolarized
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Diagnostics
TDM – FP Measurement modes
Global Systems Support RIC Version 3.0 Operator Training COBAS Integra 400 plus
Diagnostics
FP Technology Overview
Global Systems Support RIC Version 3.0 Operator Training COBAS Integra 400 plus
Diagnostics
Calibration:
Interaction tracer, antibody and calibrators of known amount of
drugs produce a curve relating drug concentration to
polarization. The mP units obtained can be correlated to the
drug level in patient’s serum by comparison with the calibration
curve in the assay.
Low
concentration of
drugs
Logit/Log 4
220
180
Millipolarization Rates
High
140
concentration of
drugs
100
60
0 12 24 36 48
Conc. [µg/ml]
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Pre- and Post Dilution
Diagnostics
Block Online Dilutions for TDM tests:
To dilute samples for TDM tests zero calibrator is used for the
diluent.
Only a manual dilution factor can be entered in the work area
Orders
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Pre- and Post Dilution
Diagnostics
Block Online Dilutions for TDM tests:
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Diagnostics
TDM Technologies
FPIA - Fluorescent labeled immunoassay
Global Systems Support RIC Version 3.0 Operator Training COBAS Integra 400 plus
Diagnostics
TDM Technologies
FPIA - Fluorescent labeled immunoassay
Cleaner Cassette
• When using Digoxin together with ALBT, AT3, THC, CHE, CHE-
D, LIP
Diagnostics