Document No. : INS-PP-EN (Rev.

03)
Revision date : November 12, 2018

Do not interchange test components between different lots or

use test components after the expiration date, either of which
might yield incorrect test result(s).
Do not reuse cartridges or detector tubes. A detector tube should
be used for processing of one sample only. A cartridge should be
used for testing one sample only.

PCT Plus
The cartridge should remain sealed in its original pouch until just
before use. Do not use the cartridge, if pouch is damaged or has
already opened.
Frozen sample should be thawed only once. For shipping,
samples must be packed in accordance with local regulations. A
INTENDED USE Sample with severe hemolysis and/or hyperlipidemia must not
ichroma™ PCT Plus is a fluorescence Immunoassay (FIA) for the be used.
quantitative determination of Procalcitonin (PCT) in human whole Allow the cartridge, the detector and the sample to be at a room
blood/serum/plasma. It is useful as an aid in management and temperature for approximately 30 minutes before use.
monitoring of bacterial infection and sepsis. The instrument for ichroma™ tests may generate slight vibration
For in vitro diagnostic use only. during use.
Used detectors, pipette tips and cartridges should be handled
carefully and discarded by an appropriate method in accordance
INTRODUCTION
with relevant local regulations.
Identifying sepsis is a daily challenge in intensive care unit of every An exposure to larger quantities of sodium azide may cause
hospital. Early assessment of sepsis is vital for determination of the certain health issues like convulsions, low blood pressure and
appropriate treatment since various therapeutic strategies are known heart rate, loss of consciousness, lung injury and respiratory
to improve survival of patients with sepsis. failure.
In healthy people, the concentration of plasma PCT is below 0.1 ichroma™ PCT Plus will provide accurate and reliable results
ng/mL. The level of PCT rises rapidly after a bacterial infection with subject to the below conditions.
systemic consequences. It can also be elevated by other situation - ichroma™ PCT Plus should be used only in conjunction with
such as major surgery, severe burns, or in neonates. However, it instrument for ichroma™ tests.
returns to baseline rapidly. Viral infections, bacterial colonization,
localized infections, allergic disorders, autoimmune diseases, and - Have to use recommended anticoagulant sample.
transplant rejection do not usually induce a significant PCT response Sample type Recommended anticoagulant
(values <0.5 ng/mL). Therefore, by evaluating PCT concentrations, the Whole blood
physicians are able to engage in the risk assessment for progression to EDTA, heparin, citrate
Plasma
severe sepsis and septic shock. Serum Not applicable.

PRINCIPLE
STORAGE AND STABILITY
The test uses a sandwich immunodetection method; Dried
The cartridge is stable for 24 months (while sealed in the original
antibodies in the detector tube, once diluted with the diluent, bind
aluminum foil pouch) if stored at 4-30 °C.
with antigens in the sample to form antigen-antibody complexes.
The detector and the diluent are stable for 24 months if stored at
These complexes then migrate through the nitrocellulose matrix and
2-8 °C.
are captured by another sets of immobilized antibodies on the test line.
After the cartridge pouch is opened, the test should be
The more antigens in the sample, the more antigen-antibody
performed immediately.
complexes, which leads to a stronger fluorescence signal. This signal
then is interpreted by the reader to display the PCT concentration in
the sample. LIMITATION OF THE TEST SYSTEM
The test may yield false positive result(s) due to the cross-
COMPONENTS reactions and/or non-specific adhesion of certain sample
components to the capture/detector antibodies.
ichroma™ PCT Plus consists of ‘Cartridges’, ‘Detectors’, ‘Diluent’,
The test may yield false negative result(s) due to the non-
‘Capillary tubes’ and an ‘ID chip’.
responsiveness of the antigen to the antibodies which is most
The cartridge contains a test strip, the membrane which has
common if the epitope is masked by some unknown components,
streptavidin at the test line, with chicken IgY at the control line.
so therefore not being able to be detected or captured by the
Each cartridge is individually sealed in an aluminum foil pouch
antibodies. The instability or degradation of the antigen with
containing a desiccant. 25 sealed cartridges are packed in a box
time and/or temperature may also cause the false negative as it
which also contains an ID chip and 25 sealed capillary tubes.
makes antigen unrecognizable by the antibodies.
The detector contains anti human PCT-fluorescence conjugate,
Other factors may interfere with the test and cause erroneous
anti chicken IgY-fluorescence conjugate, bovine serum albumin
results, such as technical/procedural errors, degradation of the
(BSA) as a stabilizer and sodium azide as a preservative in
test components/reagents or presence of interfering substances
phosphate buffered saline (PBS).
in the test samples.
Each detector contains 2 granules. 25 tubes of detector are
Any clinical diagnosis based on the test result must be supported
packed in a pouch and packed in a box with 5 ml of diluent.
by a comprehensive judgment of the concerned physician
including clinical symptoms and other relevant test results.
WARNINGS AND PRECAUTIONS
For in vitro diagnostic use only. MATERIALS SUPPLIED
Follow the instructions and procedures described in this
REF CFPC-64
‘Instruction for use’.
Use only fresh samples and avoid direct sunlight. Components of ichroma™ PCT Plus
Lot numbers of all the test components (cartridge, ID chip, Cartridge Box:
detectors and diluent) should agree.

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Document No. : INS-PP-EN (Rev. 03)
Revision date : November 12, 2018

- Cartridges 25 1) Transfer 150 µL of diluent using a pipette to a tube containing

- 35 µL Capillary tube 25 detector granules.
2) Transfer 35 µL of sample (Human whole blood/ serum/ plasma/
- ID Chip 1
control) to the detector tube.
- Instruction For Use 1 *If you use a capillary tube(35 µL), put it into the detector tube
after collecting whole blood sample.
Buffer Box 3) Close the lid of the detector tube and mix the sample thoroughly
 For ichorma™ II, ichroma™ 100 by shaking it about 20 times.
- Detectors (Capped with plastic lid) 25 4) Pipette out 75 µL of a sample mixture and load it into the sample
well on the cartridge.
- Diluent 1
5) Leave the sample-loaded cartridge at room temperature for 12
 For AFIAS-50 minutes.
- Detectors (Sealed with aluminum foil) 25 Scan the sample-loaded cartridge immediately when the
- Diluent 1 incubation time is over. If not, it will cause inexact test result.
6) To scan the sample-loaded cartridge, insert it into the cartridge
holder of the instrument for ichroma™ tests. Ensure proper
MATERIALS REQUIRED BUT SUPPLIED ON DEMAND
orientation of the cartridge before pushing it all the way inside
Following items can be purchased separately from ichroma™ PCT the cartridge holder. An arrow has been marked on the cartridge
Plus. especially for this purpose.
Please contact our sales division for more information. 7) Press ‘Select’ button on the instrument for ichroma™ tests to
Instrument for ichroma™ tests start the scanning process.
- ichroma™ II REF FPRR021 8) Instrument for ichroma™ tests should start scanning the sample-
loaded cartridge immediately.
- ichroma™ 100 REF FPRR029
9) Read the test result on the display screen of the instrument for
- AFIAS-50 REF FPRR022 ichroma™ tests.
Boditech PCT Plus Control REF CFPO-225
<Single Mode>
SAMPLE COLLECTION AND PROCESSING 1) Transfer 150 µL of diluent using a pipette to a tube containing
detector granules.
The sample type for ichroma™ PCT Plus is human whole 2) Transfer 35 µL of sample (Human whole blood/ serum/ plasma/
blood/serum/plasma. control) to the detector tube.
It is recommended to test the sample within 24 hours after *If you use a capillary tube(35 µL), put it into the detector tube after
collection collecting whole blood sample.
Take precautions on the collected sample because it's reported 3) Close the lid of the detector tube and mix the sample thoroughly
the concentration is rapidly changed when the sample for PCT by shaking it about 20 times.
test is kept at room temperature or refrigerated.
4) Pipette out 75 µL of a sample mixture and load it into the sample
The serum or plasma should be separated from the clot by
well on the cartridge.
centrifugation within 3 hours after the collection of whole blood.
5) To scan the sample-loaded cartridge, insert it into the cartridge
If longer storage is required, e.g. if the test could not be
holder of the instrument for ichroma™ tests. Ensure proper
performed within 24 hours, serum or plasma should be
immediately frozen below -20 °C. The freezing storage of sample orientation of the cartridge before pushing it all the way inside
up to 3 months does not affect the quality of results. the cartridge holder. An arrow has been marked on the cartridge
Do not freeze whole blood sample in any case. especially for this purpose.
Once the sample was frozen, it should be thawed only once and 6) Press ‘Select’ or ‘START’ button on the instrument for ichroma™
only for test, because repeated freezing and thawing can result tests.
in the changed test values. 7) Cartridge goes inside the Instrument for ichroma™ tests and will
automatically start scanning the sample-loaded cartridge after 12
TEST SETUP min.
8) Read the test result on the display screen of the instrument for
Check the contents of ichroma™ PCT Plus: Sealed Cartridge, ichroma™ tests.
Detectors, Diluent, Capillary tubes and ID Chip. (Please refer to the reader’s operation manual for complete
Ensure that the lot number of the cartridge matches that of the
information and operation instructions.)
ID chip as well as the buffer box.
Keep the sealed cartridge (if stored in refrigerator) and the buffer
box at room temperature for at least 30 minutes just prior to the ▶ AFIAS-50
test. Place the cartridge on a clean, dust-free and flat surface. 1) Insert the tip array in the tip station.
Turn on the instrument for ichroma™ tests. 2) Insert the detector array in the Reagent station and cover the
Insert the ID Chip into the ID chip port of the instrument for reagent station.
ichroma™ tests. 3) Open the diluent and insert the diluent in the diluent station.
Press the ‘Select’ button on the instrument for ichroma™ tests. 4) Open the cover of the magazine station and pull and lift the
(Please refer to the ‘Instrument for ichroma™ tests Operation cartridge magazine.
Manual’ for complete information and operating instructions.) 5) Insert the cartridges in the cartridge magazine individually.
6) Insert the cartridge loaded cartridge magazine into the magazine
TEST PROCEDURE station and close the cover of the magazine station.
7) Insert the sample tube into the blood collection tube rack and
▶ ichroma™ II, ichroma™ 100 load the blood collection tube rack into the sampling station
(loading part).
<Multi Mode> 8) Tap the button located in the upper side of the No. of test

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Document No. : INS-PP-EN (Rev. 03)
Revision date : November 12, 2018

cartridge region to select ID chip what you want to use. Cholesterol 13 mmol/L
9) When the selected cartridge slot is activated, set the number of D-Glucose 55 mmol/L
test cartridge by tapping. Hemoglobin 2 g/L
10) Tap the button located in the upper side of the No. of reagent
L-Ascorbic acid 170 umol/L
region to select ID chip what you want to use.
Triglyceride 37 mmol/L
11) When the selected slot is activated, set the number of Detector
by tapping. EDTA 3.4 umol/L
12) Set the number of pipette tips by tapping. Heparin 3,000 U/L
13) Tap the ‘START’ button on the left upper of the main screen to Citrate 2 mg/mL
start test.
(Please refer to the AFIAS-50 operation manual for complete Precision
information and operation instructions.) - Between Lot
One person tested three different lots of ichroma™ PCT Plus, ten
times at each concentration of the control standard.
INTERPRETATION OF TEST RESULT - Between person
Instrument for ichroma™ tests calculates the test result Three different persons tested ichroma™ PCT Plus, ten times at
automatically and displays PCT concentration of the test sample each concentration of the control standard.
in terms of ng/mL. - Between day
The cut-off (reference value): 0.5 ng/mL One person tested ichroma™ PCT Plus during five days, ten times
- ichroma™ PCT Plus should be considered as a screening tool only. at each concentration of the control standard.
In case of a positive result (above 0.5 ng/mL), consult a physician - Between site
to discuss the test result. The physician may decide further Three persons tested ichroma™ PCT Plus at three different sites,
ten times at each concentration of the control standard.
course of action.
- Test result of > 2 ng/mL may reflect severe sepsis. between Lot between person between day between site
Conc.
(ng/mL) CV CV CV
mean CV (%) mean mean mean
Diagnosis of bacterial infection/sepsis (%) (%) (%)
[ng/mL] state 0.2 0.2 5.6 0.2 5.64 0.2 5.92 0.2 5.98
PCT<0.5 Local bacterial infection is possible 0.78 0.79 6.03 0.78 5.8 0.78 5.78 0.77 5.22
0.5≤PCT<2 Infection is possible 3.13 3.19 5.94 3.14 6.24 3.11 6.03 3.11 5.86
Infection (sepsis) is likely, unless other cause is
2<PCT≤10 Accuracy
known
PCT>10 Severe bacterial sepsis or septic shock The accuracy was confirmed by 3 different lots testing ten times
Working range: 0.02-50 ng/mL each different concentrations.
PCT
Lot 1 Lot 2 Lot 3 AVG Recovery (%)
[ng/mL]
QUALITY CONTROL 0.2 0.2 0.2 0.2 0.2 101%
0.78 0.75 0.8 0.77 0.77 99%
Quality control tests are a part of the good testing practice to 3.13 3.17 3.16 3.11 3.15 101%
confirm the expected results and validity of the assay and should
be performed at regular intervals.
The control tests should be performed immediately after opening Comparability
a new test lot to ensure the test performance is not altered. PCT concentration of 100 standard materials were quantified
Quality control tests should also be performed whenever there is independently with ichroma™ PCT Plus (ichroma™ II, AFIAS-50
any question concerning the validity of the test results. and ichroma™ 100) and Cobas e411 (Roche Diagnostics Inc.
Control materials are not provided with ichroma™ PCT Plus. For Switzerland) as per prescribed test procedures. Test results were
more information regarding obtaining the control materials, compared and their comparability was investigated with linear
contact Boditech Med Inc.’s Sales Division for assistance. regression and coefficient of correlation (R). Linear regression
(Please refer to the instruction for use of control material.) and coefficient of correlation between the two tests are as
follows respectively.
PERFORMANCE CHARACTERISTICS Cobas e411
coefficient of
Analytical sensitivity Linear regression
correlation (R)
- Limit of Blank (LoB) 0.01 ng/mL ichroma™ Ⅱ y = 0.9971x + 0.242 0.9923
- Limit of Detection (LoD) 0.02 ng/mL
AFIAS-50 y = 1.0093x + 0.0593 0.9895
- Limit of Quantification (LoQ) 0.02 ng/mL
ichroma™ 100 y = 1.0013x + 0.0936 0.9927
Analytical specificity
- Cross reactivity 60.00
There was no significant cross-reactivity from these materials
with the ichroma™ PCT Plus test measurements. 50.00
Cross-reactivity material Conc. [ng/mL]
ichroma™ II [ng/ml]

40.00 y = 0.9971x + 0.242

Pro-BNP 100 R² = 0.9847
Pro-GRP 100 30.00
Pro-ANP 100 20.00

- Interference 10.00
There was no significant interference from these materials with
0.00
the ichroma™ PCT Plus test measurements.
0.00 10.00 20.00 30.00 40.00 50.00 60.00
Interference material Conc.
Cobas e411 [ng/ml]
Bilirubin (conjugated) 342 umol/L

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Document No. : INS-PP-EN (Rev. 03)
Revision date : November 12, 2018

Note: Please refer to the table below to identify various symbols

60.00

50.00
y = 1.0093x + 0.0593
40.00
R² = 0.9791
AFIAS-50 [ng/ml]

30.00

20.00

10.00

0.00
0.00 10.00 20.00 30.00 40.00 50.00 60.00
Cobas e411 [ng/ml]

60.00

50.00
y = 1.0013x + 0.0936
40.00
ichroma™ 100 [ng/ml]

R² = 0.9854
30.00

20.00
For technical assistance; please contact:
10.00 Boditech Med Inc.’s Technical Services
Tel: +82 33 243-1400
0.00
E-mail: [email protected]
0.00 10.00 20.00 30.00 40.00 50.00 60.00
Cobas e411 [ng/ml]

Boditech Med Incorporated

REFERENCES 43, Geodudanji 1-gil, Dongnae-myeon,
Chuncheon-si, Gang-won-do, 24398
1. Procalcitonin as a Diagnostic Test for Spesis: Health Technology Republic of Korea
Assessment in the ICU. Gattas and Cook, J Crit Care. 2003, 18:52-
Tel: +(82) -33-243-1400
8.
Fax: +(82) -33-243-9373
2. A new strategy for the development of monoclonal antibodies for
www.boditech.co.kr
the determination of human procalcitonin in serum samples.
Kremmer et al, Anal Bioanal Chem. 2012, 402:989-995.
Obelis s.a
3. Application of procalcitonin (PCT) – Q test for early detection of
Bd. Général Wahis 53,
bacteremia and sepsis. Vetcheva-Dobrevsky et al, R. Vatcheva-
1030 Brussels, BELGIUM
Dobrevsky et al, Biotechnol. & Biotechnol. Eq. 2004, 177184
4. Comparison of procalcitonin (PCT) and C-reactive protein (CRP) Tel: +(32) -2-732-59-54
plasma concentrations at different SOFA scores during the course Fax: +(32) -2-732-60-03
of sepsis and MODS. Meisner et al, Crit Care. 1999, 3:45-50. E-Mail: [email protected]
5. Diagnostic Value of Procalcitonin Levels as an Early Indicator of
Sepsis. Guven et al, Am J Emerg Med. 2002, 20:202-206.
6. Procalcitonin: how a hormone became a maker and mediator of
sepsis. Beat Muller et al, Swiss MED WKLY, 2001, 595-602
7. Sepsis biomarkers: a review, Charalampos pierrakos et al, 2010,
12-18
8. Interference Testing in Clinical Chemistry; Approved Guideline
Second Edition. Robert J. McEroe, PhD, Mary F. Burritt, PhD,
Donald M. Powers, PhD, Douglas W. Rheinheimer, MT, Brian H.
Wallace, PhD, Clinical and Laboratory Standards Institute

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