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Boditech Med Inc. Document No.

: INS-CA-CN

COMPOSITION OF REAGENTS
i-CHROMA hsCRP-All in one
i-CHROMA hsCRP-All in one consists of Test Device and
ImmunoAssay for Quantitative and Point of Care Detection Buffer. Test Device is individually sealed with a
desiccant in aluminum pouch, and Detection Buffer is packed and
Testing (POCT) Quick Measurement of high delivered separately from Test Device in a Styrofoam box filled
sensitivity C-Reactive Protein (hsCRP) and C- with ice pack.
Reactive Protein (CRP) in Human y Test Device contains a test strip in which murine monoclonal
Serum/Plasma/Whole blood with i-CHROMA antibody against human CRP and of rabbit IgG has been
Reader System. immobilized on the test and on the control line of strip,
respectively.
y Detection Buffer contains fluorescence-labeled anti-CRP
(Mouse monoclonal), fluorescence-labeled anti-rabbit IgG,
BSA as a stabilizer, and Sodium Azide as a preservative in PBS.
INTENDED USE
i-CHROMA hsCRP-All in one along with i-CHROMA Reader is
a fluorescence immunoassay that measures hsCRP and CRP in WARNINGS AND PRECAUTIONS
serum, plasma, and whole blood. The test is used as an aid to
predict future cardiovascular diseases (CVD) as well as to see y IVD For In Vitro Diagnostic Use.
infection and inflammation. y Carefully follow the instructions and procedures described in
this insert. REF Catalog No. i-CHROMA hsCRP-
25/50/100/200
INTRODUCTION
y Don’t use Test Device if its lot # does not match with ID Chip
C-Reactive Protein (CRP) is synthesized by the liver .The CRP level # that is inserted onto the instrument.
may rise from a normal level of <5 mg/L to 500 mg/L during the
body’s general, non-specific response to infectious and other acute y i-CHROMA hsCRP-All in one is only operational in i-
inflammatory events. CHROMA Reader. And tests should be applied by
For some time, the measurement of CRP concentration has been used professionally trained staff working in certified laboratories at
as a clinical tool for monitoring autoimmune diseases and infectious some remove from the patient and clinic at which the sample(s)
processes, such as differential Diagnosis of bacterial infection and viral is taken by qualified medical personnel.
infection, therapy monitoring,and rheumatoid arthritis1,2.
It has recently been suggested that along with serum cholesterol, may y LOT Neither inter-change materials from different
be marker of diagnosis in cardiovascular diseases (acute myocardial product lots nor use beyond the expiration date. The use
infarction). And, hsCRP is emerging as the strongest and most of medical device beyond expiration date may affect on
independent predictive risk factor for CVD7,8. test result.
A statement regarding use of high sensitivity C-reactive protein to
assess risk of cardiovascular diseases without inflammatory events: y i-CHROMA hsCRP-All in one Test Device should
¾ lower than 1.0 mg/L, low risk. remain in its original sealed pouch until ready to use. Do
¾ between 1.0 and 3.0 mg/L, average risk. not use the Test Device if the pouch is damaged or the
¾ higher than 3.0 mg/L, high risk. seal is broken. Discard after single use.
For infection and inflammatory events, CRP normal reference:
y CRP Test Device and Reader should be used away from
஖10.0mg/L.
vibration and magnetic field. During normal usage, i-
PRINCIPLE CHROMA hsCRP-All in one may introduce minute vibration,
which should be regarded normal.
i-CHROMA hsCRP-All in one is based on fluorescence
immunoassay technology9, 10. i-CHROMA hsCRP-All in one uses y Use separate clean pipette tips and sample vials for
a sandwich immunodetection method, such that by mixing different specimens. The pipette tips and sample vials
detection buffer with blood specimen in test vial, the fluorescence- should be used for one specimen only. Discard after
labeled detector anti-hsCRP antibody in buffer binds to hsCRP single use.
antigen in blood specimen. As the sample mixture is loaded onto y Blood specimens, used test devices, pipette tips and
the sample well of the test device and migrates the nitrocellulose sample vials are potentially infectious. Proper laboratory
matrix of test strip by capillary action, the complexes of detector safety techniques, handling and disposal methods should
antibody and hsCRP are captured to anti-hsCRP sandwich pair be followed in accordance with standard procedures and
antibody that has been immobilized on test strip. Thus the more relevant regulations observed by microbiological hazard
hsCRP antigen is in blood specimen, the more complexes are materials.
accumulated on test strip. Signal intensity of fluorescence of
detector antibody reflects amount of hsCRP captured and is y i-CHROMA hsCRP-All in one can be used as diagnosis and
microprocessed from i-CHROMA Reader to show hsCRP assessment for infection and inflammation or high risk of CVD.
concentration in blood specimen. The default result unit of i- The results should be interpreted by the physician along with
CHROMA hsCRP-All in one is displayed as an mg/L from i- clinical findings and other laboratory test results.
CHROMA Reader. The working range and the detection limit of i- y Do not smoke, eat, or drink in areas in which specimens or kit
CHROMA hsCRP-All in one system are 0.5-200 mg/L. and 0.1 reagents are handled.
mg/L, respectively.

Discard two drops of anticoagulant and allow to be clotted. another specimen should be obtained and tested. sample. the serum/plasma should be Make sure direction of Test Device and push the device stored at -20o C until tested. If specimens are to be shipped. blood out of capillary. RESULT i-CHROMA Reader calculates hsCRP test results automatically MATERIALS PROVIDED and displays hsCRP concentration on the screen as form of mg/L. Insert Test Device onto the holder of i-CHROMA Reader. Read the results on the display screen of i-CHROMA Reader homogeneous before testing. If you want Insert 1/box to perform QC of Test Kit. Anticoagulants other than EDTA for plasma specimen have not 11. the clot as soon as possible to avoid hemolysis. collect the blood in a tube treated with EDTA. to confirm the expected QC results. i-CHROMA Reader REF Catalog No. Document No. refer to the Operation Manual for i- CHROMA Reader. collect the blood in a tube without 9. Shake the assembled tube gently 5 times by inversion to take the blood. and leave it at room temperature for a couple of minutes. Check/insert ID Chip onto the instrument. serum. The detection buffer is stable up to 18 months. Frozen specimens must be or tear out the print for record. they should be packed in compliance with regulations. FR-203 and before using a new kit with patient specimens. Device. y The specimen must be at room temperature and be 13. MATERIALS REQUIRED BUT NOT PROVIDED y A quality control test should be performed at regular intervals. allow the Detection Buffer for 10 minutes to return to room temperature before testing. i-CHROMA hsCRP-25/50/100/200 Box contains: Quality Control Test Devices 25/50/100/200T/box Quality Control Detection Buffer 25/50/100/200 Tubes (500 μL/tube) y A quality control test using commercially available controls Sample collector 25/50/100/200/box should be performed as a part of good testing practice. REF Catalog No. PROCEDURE y Store i-CHROMA hsCRP-All in one Test Device at 4°- 30°C in its sealed pouch. If a specimen appears to be complete instructions on use of the Test. Set a Test Device on a dust-free clean place. after preparation of specimen. Remove the serum from reagent onto the paper towel before applying to the cartridge. y It is recommended to avoid using severely hemolyzed ¾ Refer to i-CHROMA Reader Operation Manual for the specimens whenever possible. i-CHROMA hsCRP-All in one For further information. Draw whole blood. completely thawed.8°C. 4. we recommend using Kamiya CRP control. apply it back all the way. it is remotely possible that only collector (10 μL). Take out a tube containing Detection Buffer from refrigerator sealed pouch. If testing cannot be conducted within an hour 12.Boditech Med Inc. empty blood collection capillary y The storage and shipping of Test Kit should be complied as 5. H) y Store the detector buffer in a refrigerator at 2° . The test can be performed with either serum or plasma or whole 8. thoroughly mixed. and to assure the accuracy of patient results. y For serum sample. Instrument will automatically scan the Test immediately after specimen was taken. test device is stable for 18 months (while in the sealed pouch) if stored at 4°-30°C. If necessary. Remove the cap off the top of tube. Apply only two drops onto the sample well of a cartridge. 2. or control with a sample indicated in manual. : INS-CA-CN Thermal Printer STROAGE AND STABILITY i-CHROMA hsCRP Control(L. severely hemolyzed. Lancet (if whole blood) y Once removed from refrigerator. and brought to room temperature prior to testing. y Do not remove the device from the pouch until ready to use. Assemble the capillary and the tube into one. In case of use whole blood. 6. allow a minimum of 10 minutes for the Test Device to reach room temperature while it is in the 3. Make a puncture on the top of the detector tube by inserting an The Test Device should be used immediately once opened. part of Test Kit is affected by stability problems. plasma. y If stored in a refrigerator. wipe out the excess blood outside of the capillary with paper towel or Kimwipes SAMPLE COLLECTION AND PREPARATION 7. i-CHROMA hsCRP-All in one 1. been evaluated. Leave it in Room Temperature 3 mins. to confirm the validity of the ID Chip 1/box assay. Make sure that the Test Device lot # matches with ID Chip #. controls . For plasma 10. Boditech Med Inc. However.

with 10 runs per day results obtained. 20 replicates were tests produce the expected QC results.988 CV<20%.988 and R=0. such that they become no longer recognizable by antibodies. For the inter-assay imprecision. . 10 y Other factors may interfere with i-CHROMA hsCRP-All in one and may cause erroneous results. 10%. be run whenever there is any question concerning the validity of tests were conducted on 10 sequential days. or temperature. the and with 10 replicates at each CRP concentration. These include technical 0 or procedural errors. There was no significant TBA 200FR (mg/l) interference with the CRP measurement. The effectiveness of the test is R=0.9748X-0. test device is ready to use with patient specimens. nor was their any significant assay cross-reactivity with those bio-molecules tested. Analytical Sensitivity: Analytical sensitivity means the lowest concentration of CRP that the test system can detect with 40 y=0. Troponin I. Upon confirmation of the expected results. and non. and 50 y=1. 50%. 25%. This control indicates that the test device was inserted and read properly by i-CHROMA Reader. Sample was assayed in LIMITATIONS OF THE PROCEDURE triplicate in one analytical run at each CRP level. such as Hb. Analytical sensitivity of i-CHROMA hsCRP-All in one was determined by testing 10 times with three lots of i-CHROMA (mg/l) 30 reagents.g. ALT. Linearity: The high pool (~200 mg/L) was diluted with the very low pool (~0. In the investigated with linear regression and correlation of coefficient case of false negative results. as well as additional substances in blood specimens. serums were used for TBA 200FR and BNII ProSpec. the components of serum from individual to antibodies. 100%. The coefficient of linear regression was R=0. For information Imprecision of i-CHROMA hsCRP-All in one about obtaining the controls. CRP (mg/L) Intra-assay Inter-assay Mean S. The test specific adhesion of some components in human blood that results were compared and their compatibilities were have similar epitopes to capture and detector antibodies.997. heparin or citrate) other than EDTA has not been evaluated in i-CHROMA hsCRP-All in 20 one and thus should not be used. 5% and 0%. and serum amyloid P component 0 were added to test specimen with much higher level than their 0 10 20 30 40 50 physiological level in normal blood.989 highly dependent on storage of kits and sample specimens at 40 optimal conditions.Boditech Med Inc. Analytical sensitivity of i-CHROMA hsCRP-All in 20 one system was 0. : INS-CA-CN should be tested to confirm the test procedure. While the y The false positive results include cross-reactions with some whole blood was used for i-CHROMA hsCRP-All in one. If CRP 5. 75%.14791 R=0. such that antigen cannot be seen by the antibodies. i-CHROMA (mg/l) 30 y Plasma using anticoagulants (e.26972 degraded other test components. 4. CEA.5 mg/L. AFP. An invalid result    from the internal control causes an error message on i- CHROMA Reader indicating that the test should be repeated. Specificity: Other bio-molecules. Imprecision: For the intra-assay imprecision. Tracebility: Traceable to CAP/BCR/IFCC Reference Preparation for CRM 470. i-CHROMA hsCRP-All in one was comparable well to non-responsiveness of antigen to the antibodies by that certain other methods (R=0. instability of CRP antigen. and to verify the 3. Albumin. Comparability: The CRP concentrations of 150 clinical Test results do not agree with the clinical evaluation.989) 10.50 mg/L) to the following final percentages. additional specimens were quantified independently with i-CHROMA tests should be performed.D CV% Procedure Control y Each i-CHROMA hsCRP Test Device contains internal    control that satisfies routine quality control requirements. contact Boditech Med Incorporate’s Technical Services for assistance. unknown components are masking its epitope. This internal control is performed each time a patient sample is    tested. Control standards are not provided with this test kit.) automatic analyzer. y The results of i-CHROMA hsCRP-All in one should be evaluated with all clinical and laboratory data available. 0 10 20 30 40 50 BN II ProSpec (mg/l) PERFORMANCE CHARACTERISTICS 50 1. Document No.D CV% Mean S.05727X+0. hsCRP-All in one and TBA 200FR (Toshiba Inc.) and BNII ProSpec (Dade Behring Inc. resulting in degradation with time and. the most common factors are: (R). QC specimens should also tested at each control sample. CK-MB. 10 2.

Boditech Med Inc. 4.boditech.co. Chem. 111:1805-1812.kr 99:237-242. Ridker PM. +82-33-243-1400 3. 2. et al. Rifai N and Ridker PM. 7. Document No. Harris PC. Lab. Sund M. Claus DR. Chem. Korea function. Moon JD. Date of last revision: August. 8. High-Sensitivity C-Reactive Protein: A novel and Promising Marker of Coronary Heart Disease. Chuncheon-si. predicts future risk of coronary heart F. Soyanggang-ro. 296:242-245. Volanakis JE.56.38:189-197.kr Boditech Med Incorporated Office Address: 43. Liuzzo G. Park SY. Clin. Frohlich M. Scand J Clin Lan Invest 1972. Proposed Cardiovascular Risk Assessment Algorithm Using High-Sensitivity C-reactive protein and Lipid i-CHROMATM is registered trademarks of Boditech Med Screening. Ridker PM.co. J Clin. Clin Chem 1999.29:407-411 Boditech Med Inc. Gewurz H. T. Invest 2003. C-reactive protein and other markers of inflammation in the prediction of cardiovascular disease in women. Biasucci LM. Elevated levels of C. Circulation 1999. Pepys MB and Hirschfield GM. 99:855-860. Gang-won-do. 2015 reactive protein at discharge in patients with unstable angina predict recurrent instability. and Rifai N. structure. Revision No: 16 6. 11. C-reactive protein: a critical update. J. quantitative whole blood immunochromatographic platform for point-of-care testing. and 200-957. Devine DV. Hennekens CH. 47(3): 403-411. RAMP(TM): A rapid. The concentration of C-reactive protein in sera from healthy indivisuals. Does inflammation cut to the heart of the matter? Science 2002. et al. Brooks DE. Clin Chim Acta 2005. 356:172-177. a sensitive marker of inflammation.’s i–CHROMA Reader Technical Services at Tel: +82-33-243-1400 E-mail: support@boditech. 45:1676-1678. 5. et al. Rifai N. express and implied warranties (including implied warranties of merchantability and fitness) are conditional upon observance of Boditech Med Inc. Grillo RL. Mol Immunol 2001. Koenig W. Osmond AP. Evaluation of fluorescence hs- CRP immunoassay for point-of –care testing. Dongnae-myeon. Clin. 10. Human C-reactive protein: expression. 2001. Buring JE. Radioimmunoassay of human C-reactive protein and levels in normal sera. +82-33-243-9373 disease in initially healthy middle-aged men. N Engl J Med 2000:342(12): 836- 843. Geodudanji 1-gil. Taubes G. 2001. 17. Korea . Chuncheon-si. Clin Med 1976. Circulation 1999. For Technical Assistance call Boditech Med Inc. Oh SW. 47:28-30. Incorporated. products.87:120-128 12. Kindmark CO. C-reactive protein. published directions with respect to the use of Boditech Med Inc. et al. www. #3-2A. 9. : INS-CA-CN REFERENCES Manufacture Address: 1. Gang-won-do.