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

22)
Revision date : November 9, 2018

detection buffer) must match each other.

Do not interchange the test components between different lots or
use the test components after the expiration date, either of which
might yield incorrect test result(s).
Do not reuse cartridges or detection buffer tubes. A detection

CRP buffer tube should be used for processing of one sample only. A
cartridge should be used for testing one sample only.
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 been opened.
INTENDED USE Frozen sample should be thawed only once. For shipping, samples
must be packed in accordance with local regulations. Sample with
ichroma™ CRP is a fluorescence Immunoassay (FIA) for the severe hemolysis and/or hyperlipidemia must not be used.
quantitative determination of CRP in human whole blood/serum/ Allow the cartridge, detection buffer and sample to be at room
plasma. It is useful as an aid in management and monitoring of temperature for approximately 30 minutes before use.
autoimmune diseases and infectious processes, such as rheumatoid The instrument for ichroma™ tests may generate slight vibration
arthritis.1,2 during use.
For in vitro diagnostic use only. Used detection buffer vial, pipette tips and cartridges should be
handled carefully and discarded by an appropriate method in
INTRODUCTION accordance with relevant local regulations.
An exposure to larger quantities of sodium azide may cause
The C-Reactive Protein (CRP) is synthesized by the liver in response to certain health issues like convulsions, low blood pressure and
interleukin-6 and well known as one of the classical acute-phase heart rate, loss of consciousness, lung injury and respiratory
reactants and as a marker of inflammation. CRP is the first acute-phase failure.
protein to be described and is an exquisitely sensitive systemic marker ichroma™ CRP will provide accurate and reliable results subject to
of inflammation and tissue damage. The acute-phase response the below conditions.
comprises the nonspecific physiological and biochemical responses of
endothermic animals to most forms of tissue damage, infection, - Use ichroma™ CRP should be used only in conjunction with
inflammation, and malignant neoplasia. The serum CRP level may rise instrument for ichroma™ tests.
from a normal level of <5 mg/L to 500 mg/L during the body’s general, - Have to use recommended anticoagulant sample.
non-specific response to infectious and other acute inflammatory events. Sample type Recommended anticoagulant
For some time, the measurement of CRP concentration has been used Whole blood
EDTA, Sodium heparin, Sodium citrate
as a clinical tool for monitoring autoimmune diseases and infectious Plasma
processes, such as rheumatoid arthritis.1,2 Serum Not applicable.

PRINCIPLE STORAGE AND STABILITY

The test uses a sandwich immunodetection method; the detector The cartridge is stable for 20 months (while sealed in an aluminum
antibody in buffer binds to antigen in sample, forming antigen-antibody foil pouch) if stored at 4-30 °C.
complexes, and migrates onto nitrocellulose matrix to be captured by The detection buffer pre-dispensed in a tube is stable for 20
the other immobilized-antibody on test strip. months if stored at 2-8 °C.
The more antigen in sample forms the more antigen-antibody After the cartridge pouch is opened, the test should be performed
complex and leads to stronger intensity of fluorescence signal on immediately.
detector antibody, which is processed by instrument for ichroma™ tests
to show CRP concentration in sample. LIMITATION OF THE TEST SYSTEM
The test may yield false positive result(s) due to the cross-reactions
COMPONENTS and/or non-specific adhesion of certain sample components to the
ichroma™ CRP consists of ‘Cartridges’, ‘Detection Buffer Tubes’, capture/detector antibodies.
‘Sample Collectors’ and an ‘ID chip’. The test may yield false negative result(s) due to the non-
The cartridge contains a test strip, the membrane which has anti responsiveness of the antigen to the antibodies which is most
human CRP at the test line, while rabbit IgG at the control line. common if the epitope is masked by some unknown components,
Each cartridge is individually sealed in an aluminum foil pouch so therefore not being able to be detected or captured by the
containing a desiccant. 25 sealed cartridges are packed in cartridge antibodies. The instability or degradation of the antigen with time
box which also contains an ID chip. and/or temperature may also cause false negative result as it
The detection buffer contains anti-human CRP fluorescence makes antigen unrecognizable by the antibodies.
conjugate, anti-rabbit IgG fluorescence conjugate, bovine serum Other factors may interfere with the test and cause erroneous
albumin (BSA) as a stabilizer and sodium azide in phosphate results, such as technical/procedural errors, degradation of the test
buffered saline (PBS) as a preservative. components/reagents or presence of interfering substances in the
The detection buffer is pre-dispensed in a tube. 25 detection buffer test samples.
tubes are packaged in detection buffer box and further packed in a Any clinical diagnosis based on the test result must be supported
Styrofoam box with ice-pack for the shipment. 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.
Follow instructions and procedures described in this ‘Instruction
for use’.
Use only fresh samples and avoid direct sunlight.
Lot numbers of all the test components (cartridge, ID chip and

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Document No. : INS-CR-EN (Rev. 22)
Revision date : November 9, 2018

MATERIALS SUPPLIED TEST PROCEDURE

REF i-CHROMA CRP-25 <Multi Mode>
1) Make a puncture on the top of the detection buffer tube by
Components of ichroma™ CRP
inserting an empty sample collector.
Cartridge Box:
2) Draw 10 µL (Human whole blood/serum/plasma/control) of
- Cartridges 25 sample with a sample collector.
- ID Chip 1 3) Assemble the sample collector and the tube into one.
- Instruction For Use 1 4) Shake 10 times or more until the sample out of the sample
collector by inversion. The mixture of buffer and the sample
- Sample Collector 25
has to be used within 30 seconds.
Box containing Detection Buffer tubes 5) Remove the cap off the top of assembled tube. Discard two
- Detection Buffer Tubes 25 drops of reagent onto the paper towel before applying to the
cartridge
MATERIALS REQUIRED BUT SUPPLIED ON DEMAND 6) Load only two drops of the mixture onto the sample well of
the cartridge.
Following items can be purchased separately from ichroma™ CRP. 7) Leave the Cartridge at room temperature for 3 min before
Please contact our sales division for more information. inserting the device into the holder.
Instrument for ichroma™ tests Scan the sample-loaded cartridge immediately when the
- ichroma™ Reader REF FR203 incubation time is over. If not, it will cause inexact test result.
8) To scan the sample-loaded cartridge, insert it into the
- ichroma™ II REF FPRR021 cartridge holder of the instrument for ichroma™ tests. Ensure
ichroma™ Printer REF FPRR007 proper orientation of the cartridge before pushing it all the
Boditech CRP Control REF CFPO-100 way inside the cartridge holder. An arrow has been marked
on the cartridge especially for this purpose.
SAMPLE COLLECTION AND PROCESSING 9) Press ‘Select’ button on the instrument for ichroma™ tests to
start the scanning process.
The sample type for ichroma™ CRP is human Whole blood/serum 10) Instrument for ichroma™ tests will start scanning the sample-
/plasma.
loaded cartridge immediately.
It is recommended to test the sample within 24 hours after 11) Read the test result on the display screen of the instrument
collection. for ichroma™ tests.
The serum or plasma should be separated from the clot by
centrifugation within 3 hours after the collection of whole blood. < Single Mode >
If longer storage is required, e.g. if the test could not be 1) Make a puncture on the top of the detection buffer tube by
performed within 24 hours, serum or plasma should be inserting an empty sample collector.
immediately frozen below -20 °C. The freezing storage of sample 2) Draw 10 µL (Human whole blood/serum/plasma/control) of
up to 3 months does not affect the quality of results. sample with a sample collector.
Once the sample was frozen, it should be used one time only for 3) Assemble the sample collector and the tube into one.
test, because repeated freezing and thawing can result in the 4) Shake 10 times or more until the sample out of the sample
change of test values. collector by inversion. The mixture of buffer and the sample
has to be used within 30 seconds.
TEST SETUP 5) Remove the cap off the top of assembled tube. Discard two
Check the contents of ichroma™ CRP: Sealed Cartridge, Detection drops of reagent onto the paper towel before applying to the
Buffer Tubes, Sample Collector and ID Chip. cartridge
Ensure that the lot number of the cartridge matches that of the ID 6) Load only two drops of the mixture onto the sample well of
chip as well as the detection buffer. the cartridge.
Keep the sealed cartridge (if stored in refrigerator) and the 7) Inserting the device into the holder of the instrument for
detection buffer tube at room temperature for at least 30 minutes ichroma™ tests. Ensure proper orientation of the cartridge
just prior to the test. Place the cartridge on a clean, dust-free and before pushing it all the way inside the cartridge holder. An
flat surface. arrow has been marked on the cartridge especially for this
Turn on the instrument for ichroma™ tests. purpose.
Insert the ID Chip into the ID chip port of the instrument for 8) Press ‘Select’ or ‘START’ button on the instrument for
ichroma™ tests. ichroma™ tests.
Press the ‘Select’ button on the instrument for ichroma™ tests. 9) Cartridge goes inside the Instrument for ichroma™ tests and
(Please refer to the ‘Instrument for ichroma™ tests Operation will automatically start scanning the sample-loaded cartridge
Manual’ for complete information and operating instructions.) after 3 min.
10) Read the test result on the display screen of the instrument
for ichroma™ tests.

INTERPRETATION OF TEST RESULT

Instrument for ichroma™ tests calculates the test result
automatically and displays CRP concentration of the test sample in
terms of mg/L.
The cut-off (reference value): 10 mg/L
Working range: 2.5-300 mg/L.

양식-GE02-15 (Rev. 04)

Document No. : INS-CR-EN (Rev. 22)
Revision date : November 9, 2018

inflammation, predicts future risk of coronary heart disease in

QUALITY CONTROL initially healthy middle-aged men. Circulation 1999; 99:237-242.
3. Rifai N, Ridker PM. Proposed Cardiovascular Risk Assessment
Quality control tests are a part of the good testing practice to Algorithm Using High-Sensitivity C-reactive protein and Lipid
confirm the expected results and validity of the assay and should Screening. Clin. Chem. 2001; 47:28-30.
be performed at regular intervals. 4. Rifai N and Ridker PM. High-Sensitivity C-Reactive Protein: A novel
and Promising Marker of Coronary Heart Disease. Clin. Chem.
The control tests should be performed immediately after opening 2001; 47(3): 403-411.
a new test lot to ensure the test performance is not altered. 5. Biasucci LM, Liuzzo G, Grillo RL, et al. Elevated levels of C-reactive
Quality control tests should also be performed whenever there is protein at discharge in patients with unstable angina predict
any question concerning the validity of the test results. recurrent instability. Circulation 1999; 99:855-860.
6. Taubes G. Does inflammation cut to the heart of the matter?
Control materials are not provided with ichroma™ CRP. For more Science 2002; 296:242-245.
information regarding obtaining the control materials, contact 7. Ridker PM, Hennekens CH, Buring JE, and Rifai N. C-reactive
Boditech Med Inc.’s Sales Division for assistance. protein and other markers of inflammation in the prediction of
(Please refer to the instruction for use of control material.) cardiovascular disease in women. N Engl J Med 2000:342(12): 836-
843.
8. Brooks DE, Devine DV, Harris PC, et al. RAMP(TM): A rapid,
PERFORMANCE CHARACTERISTICS quantitative whole blood immunochromatographic platform for
point-of-care testing. Clin Chem 1999; 45:1676-1678.
Analytical sensitivity 9. Oh SW, Moon JD, Park SY, et al. Evaluation of fluorescence hs-CRP
Analytical sensitivity of ichroma™ CRP was determined by testing immunoassay for point-of–care testing. Clin Chim Acta 2005;
10 times with three lots of reagents. Analytical sensitivity of 356:172-177.
10. Claus DR, Osmond AP, Gewurz H. Radioimmunoassay of human C-
ichroma™ CRP system was 0.5 mg/L. reactive protein and levels in normal sera. J. Lab. Clin Med
Specificity 1976;87:120-128.
There, in test samples, are biomolecules such as hemoglobin, CEA,
AFP, ALT, Troponin I, CK-MB, Albumin, and serum amyloid P Note: Please refer to the table below to identify various symbols.
component in higher concentration than their normal
physiological levels. But this doesn’t interfere with the ichroma™
CRP test measurements, nor occurs any significant cross-reactivity.
Precision
The intra-assay precision was calculated by one evaluator, who
tested different concentration of control standard twenty times
each with three different lots of ichroma™ CRP. The inter-assay
precision was confirmed by 3 different evaluators with 3 different
lots, testing ten times each different concentration.
Intra-assay Inter-assay
CRP (mg/L)
Mean SD CV (%) Mean SD CV (%)
1.5 1.5 0.08 5.3 1.5 0.12 7.9
40 40 2.5 6.2 40 2.8 7.1
150 150 5.6 3.7 150 6.9 4.6
Linearity
The high pool (200 mg/L) was diluted with the low pool (0.50
mg/L) to the following final percentages; 100%, 75%, 50%, 25%,
10%, 5% and 0%. Sample was assayed in triplicate in one analytical
run at each CRP level. The coefficient of linear regression was
R=0.997.
Comparability
CRP concentrations of 166 samples were quantified independently
with ichroma™ CRP and TBA-200FR as per prescribed test
procedures. Test results were compared and their comparability
was investigated with linear regression and coefficient of
For technical assistance; please contact:
correlation (R). Linear regression and coefficient of correlation
Boditech Med Inc.’s Technical Services
between the two tests were Y=0.99X + 1.0081 and R = 0.9933
Tel: +82 33 243-1400
respectively.
E-mail: [email protected]
350

300
Boditech Med Incorporated
ichroma™ CRP [mg/L]

y = 0.99x + 1.0081
250
R = 0.9933
43, Geodudanji 1-gil, Dongnae-myeon,
200 Chuncheon-si, Gang-won-do, 24398
Republic of Korea
150
Tel: +(82) -33-243-1400
100
Fax: +(82) -33-243-9373
50 www.boditech.co.kr
0
0.0 50.0 100.0 150.0 200.0 250.0 300.0 350.0 Obelis s.a
TBA-200FR [mg/L] Bd. Général Wahis 53,
1030 Brussels, BELGIUM
REFERENCES Tel: +(32) -2-732-59-54
Fax: +(32) -2-732-60-03
1. Pepys MB and Hirschfield GM. C-reactive protein: a critical update.
J Clin. Invest 2003; 111:1805-1812. E-Mail: [email protected]
2. Volanakis JE. Human C-reactive protein: expression, structure, and
function. Mol Immunol 2001;38:189-197. 3. Koenig W, Sund M,
Frohlich M, et al. C-reactive protein, a sensitive marker of

양식-GE02-15 (Rev. 04)