BIOMÉRIEUX

30 706 12670 G - en - 2018/06

Quality Control VIDAS® (QCV) ® ® ®

Automated test for use on the VIDAS system to detect abnormal operation of the VIDAS and MINI VIDAS instrument
pipette mechanisms and optical systems.

SUMMARY AND EXPLANATION PRINCIPLE

®
Quality Control VIDAS (QCV) is used to detect abnormal The test corresponds to successive aspirations/dilutions
operation of pipette mechanisms which may affect the of fluorescent substrate (4-Methyl-umbelliferone) solutions
results of biological tests. It is also intended for checking which are standardized and have varying levels of
that the optical system is capable of measuring high concentration. The aspirations are performed at different
fluorescence levels. speeds to check pump aspiration capability.
The QCV test must be run periodically in each The results obtained at the end of the test correspond to:
® ®
position of the VIDAS and MINI VIDAS instruments • a fluorescence ratio “Test Value 1” (TV1 for
®
(see User Manual), or any time that one of the above- MINI VIDAS ) for checking that the pipette mechanism
mentioned instrument problems is suspected. is operating correctly,
®
• a fluorescence reading (Reading 3 for VIDAS and R3
®
for MINI VIDAS ) for checking that the optical system is
intact.
The values obtained must be within the acceptable range
defined later in this package insert.

CONTENT OF THE KIT (60 TESTS):

60 QCV Strips STR Ready-to-use.
®
60 QCV Solid Phase Receptacles (2 x 30) SPR Ready-to-use.
1 Package insert provided in the kit or downloadable from www.biomerieux.com/techlib

DESCRIPTION The strip:

® The strip consists of 10 wells covered with a labeled,
The SPR :
®
foil seal. The label comprises a bar code which mainly
The SPR is used as a pipetting device and is identified indicates the assay code, kit lot number and expiration
by the code QCV. Only remove the required number date. The last well is a cuvette in which the fluorometric
®
of Solid Phase Receptacles (SPR ) from the pouch. reading is performed. The wells in the center of the strip
contain the various reagents required for the assay.

Description of the QCV strip:

Wells Reagents
1 Empty well: no sample is needed for this test.
2 400 µL of 4-Methyl-umbelliferone solution (100 µmol/L) in CHES buffer
(20 mmol/L, pH 9.6) + 0.9 g/L sodium azide.
3 Empty well.
4 400 µL of 4-Methyl-umbelliferone solution (0.6 µmol/L) in CHES buffer
(20 mmol/L, pH 9.6) + 0.9 g/L sodium azide.
5-6 600 µL of 4-Methyl-umbelliferone solution (0.6 µmol/L) in CHES buffer
(20 mmol/L, pH 9.6) + 0.9 g/L sodium azide.
7 Empty well.
8-9 400 µL of 4-Methyl-umbelliferone solution (26 µmol/L) in CHES
buffer (20 mmol/L, pH 9.6) + 0.9 g/L sodium azide.
10 Optical cuvette with substrate: 300 µL of 4-Methyl-umbelliferone (0.6 µmol/L) in
CHES buffer (20 mmol/L, pH 9.6) + 0.9 g/L sodium azide.

WARNINGS AND PRECAUTIONS 4. It is recommended to wear gloves as if handling

biological tests.
1. Caution: the strips are photosensitive and must
be kept in their box to be protected from light. STORAGE
2. Do not use reagents after the expiration date ®
indicated on the label. • Store the VIDAS QCV kit at 2 - 8°C. Do not freeze
3. Kit reagents contain sodium azide which can react reagents. Store all unused reagents in their box at
with lead or copper plumbing to form explosive metal 2-8°C.
azides. If any liquid containing sodium azide is • If stored according to the recommended conditions, all
disposed of in the plumbing system, drains should be components are stable until the expiration date
flushed with water to avoid build-up. indicated on the label. Do not use the reagents after the
expiration date.

bioMérieux SA English - 1
 ®
Quality Control VIDAS (QCV) 12670 G - en - 2018/06

INSTRUCTIONS FOR USE 2. Create the work list: type QCV and indicate the
Your instrument must be checked periodically using the number of tests to be run.
®
VIDAS QCV test (see User Manual), and each time 3. Load the reagent strips and Solid Phase Receptacles
®
abnormal operation of the pipette mechanism or optical (SPR ) into the instrument (Note: no desiccant is
® ®
system is suspected. needed in the SPR pouch). Be sure to close all SPR
®
It is essential to perform the VIDAS QCV test on all doors and tray covers.
the positions to ensure that the whole instrument has 4. Run the test (see User Manual). All steps will be
been checked. performed automatically by the instrument. The test
It is essential to archive work lists and their results will be completed in approximately 20 minutes.
according to the QCV periodicity in order to track results 5. After the test is completed, print the results and
obtained between two QCV tests. analyze them as instructed later in this package
1. Remove necessary components from the kit and insert. Once interpretation of results has been
return all unused components to storage at 2-8°C. validated, dispose of the used Solid Phase
®
Receptacles (SPR ) and strips into an appropriate
recipient.
RESULTS AND INTERPRETATION
®
The first reading is performed at the beginning of the assay to check that the reading 1 for VIDAS
®
reagent is intact: R1 for MINI VIDAS
®
The second reading is taken after successive aspirations which are performed at reading 2 for VIDAS
®
different speeds; they are used to check the ability of the pump to pipette properly: R2 for MINI VIDAS
The third reading is taken after a small quantity of highly concentrated substrate is reading 3 for VIDAS
®

pipetted. This operation is performed to check that the optical system is capable of R3 for MINI VIDAS
®
measuring high fluorescence levels:
®
When the test is completed, the computer automatically calculates Test Value 1 and 2 (TV1 and TV2 for MINI VIDAS )
using the 3 fluorescence readings. The calculations appear on a report.
® reading 2 reading 3
VIDAS : Test Value (TV1) = Test Value (TV2) =
reading 1 reading 1

® R2 R3
MINI VIDAS : TV1 = TV2 =
R1 R1
® ®
The values for reading 3 (R3 for MINI VIDAS ) and Test Value 1 (TV1 for MINI VIDAS ) must be within the acceptable
ranges indicated below (see diagram):
®
- Acceptable range for Test Value 1 (TV1 for MINI VIDAS ): the Test Value 1 for each position must be ≥ the value
®
indicated on the kit label. If the result of a particular position is outside the range, two new VIDAS QCV tests must
® ®
be run successively in all the positions in the section concerned (for VIDAS and MINI VIDAS ).
If at least one other non-compliant result is produced in the same section, independent of the position, take the
section offline and contact bioMérieux.
®
- Acceptable range for reading 3 (R3 for MINI VIDAS ): reading 3 for each position must be ≥ 4100 RFU. If the result
of a particular position is outside the range, take the instrument offline and contact bioMérieux.

Test Value 1
< value on kit label for 1 no
or several positions in
the section?

Test Value 1 compliant

yes

Perform VIDAS QCV test twice in

all positions in the section
concerned no
Reading 3 or R3 Reading 3 or R3
< 4100 RFU ? compliant

Test Value 1 out of range no

at least a 2nd time in the
section, independent of yes
the position?

yes

Take the section offline and Take the instrument offline and
contact bioMérieux QCV test compliant
contact bioMérieux

bioMérieux SA English - 2
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Quality Control VIDAS (QCV) 12670 G - en - 2018/06

LIMITATIONS OF THE METHOD INDEX OF SYMBOLS

®
- VIDAS QCV may produce an invalid result when Symbol Meaning
the reading 1 or R1 value is < 200 RFU. In this
case, perform the test again using a new QCV strip Catalogue number
from a new lot (if possible).
®
In Vitro Diagnostic Medical Device
- VIDAS QCV should only be used to diagnose
problems with the instrument pipette mechanism or Manufacturer
optical system. It is not a calibrator.
®
- VIDAS QCV does not diagnose temperature Temperature limit
problems or leakages.
®
- VIDAS QCV should only be used to test the Use by date
instrument.
Batch code

Consult Instructions for Use

Contains sufficient for <n> tests

Keep away from light

Date of manufacture

LIMITED WARRANTY
bioMérieux warrants the performance of the product for its stated intended use provided that all procedures for usage,
storage and handling, shelf life (when applicable), and precautions are strictly followed as detailed in the instructions for
use (IFU).
Except as expressly set forth above, bioMerieux hereby disclaims all warranties, including any implied warranties of
merchantability and fitness for a particular purpose or use, and disclaims all liability, whether direct, indirect or
consequential, for any use of the reagent, software, instrument and disposables (the “System”) other than as set forth in
the IFU.

REVISION HISTORY
Change type categories:
N/A Not applicable (First publication)
Correction Correction of documentation anomalies
Technical change Addition, revision and/or removal of information related to the product
Administrative Implementation of non-technical changes noticeable to the user
Note: Minor typographical, grammar, and formatting changes are not included in the
revision history.

Release
Part Number Change Type Change Summary
date
CONTENT OF THE KIT (60 TESTS)
DESCRIPTION
Administrative INDEX OF SYMBOLS
2018/06 12670G LIMITED WARRANTY
REVISION HISTORY
SUMMARY AND EXPLANATION
Technical
INSTRUCTIONS FOR USE

BIOMERIEUX, the BIOMERIEUX logo, SPR and VIDAS are used, pending, and/or registered trademarks belonging to bioMérieux, or
one of its subsidiaries or one of its companies.
Any other name or trademark is the property of its respective owner.

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