YumizenCR Clinical-Chemistry Reagents C-Reactive Protein (CRP) Turbidimetric Immunoassay INTENDED USE This reagent is intended for in vitro quantitative determination of C- reactive protein (CRP) inhuman serum. CLINICAL SIGNIFICANCE CC-Reactive Protein (CRP) is an acute phase protein produced by the Iverin response to lftammation, infection and tissue injury, Increased CRP concentrations occur much earler than other acute phase reactants and this rapid resporse to trauma or infection Is the {istingushing feature of CRP. In alton, CRP tevels return to normal Quickly a the end ofan acute ep'sode making CRP useful for both the Aotection of acute episodes as wellasin treatment monitoring PRINCIPLE Latex particles coated with specific rabbit anti-human CRP are Sggiutnated when mixed with samples cortsining CRP. The ‘agglutination causes an absorbance change, dependent upon the CRP Coren of the patient sample that can be quantified by comparison {rom calibrators oFknawn CRP concentrations. KIT COMPONENTS R1(Divent): Tis butter 2. Ro{Latex Reagent): Latex particles costed with specific rabbt anti human CRP 3.Caliocator Lyophilized (Cone. as mentioned on vial label) Reconstitute with + micistlied ‘STORAGE & STABILITY + R1QR2& Calibrator The sealed reagents are stable fr 24 months from manufacture date, wen stored at 2-8°C, + Working Reagent Stable during 30 days at2-8°C. Shake gant the vial btore use, Products ‘must natbe stored at:oom tomperatueforlengerthan 3Dhours during use PRECAUTIONS. 1. Ifthe reagents became turbid or the absorbance of blank reagent is. higher than 1.0000, it means that he reagentis vad and you shoul iscardit. 2, Donat freeze; rozen Latex or Dluent could change the functionality ofthetest. 3. Components from human ongin have been tested and found to be negative for te presence of HBsAg, HCV, and antivody to HIV (14). It isrocommended handle with eauton. CALIBRATION Use GRP Calbrators, The calibration in automated analyzer is stable for 2 weeks, after which @ new curve must be generatee, Re-calisrate When contol results are out of spectied tolerances, when using dlfferentlotofreagentand when theinstrument's adjusted, PREPARATION Working reagent: Swit the latex vial genty before use. Prepare the necessary volume as flow: BmRI-2miR2 CRP Calibrator (Lyophilized): Reconsttute with 1 mlcistiled water Seeiente MATERIAL REQUIRED BUT NOT PROVIDED ‘Thermostatic bath at 37°C. Spectrophotometar or photometer thermostatable at 37°C witha 640+ 2onmiter. Sample Fresh Serum (Do nol use lipaemic or haemolysod sample). Stable for 7 days at 2-81. Samples with presence of fin should be centrfuged betoretesting PROCEDURE + system Parameters Meda “we Pointed Time Reaction ‘Ascenaing Wavelength ‘540820 Blank Distiied water Sample Volume Opt Reagent Volume: O00 aL ROO VL RTS BOO ERA) Delay Time, 10 See Read Time 720 Sec Calbraior lated on the val Normal range Up S mai Linearity ime Ome Unit ma TEST PROCEDURE 1. Bring the working reagent and the photometer (cuvette holder) to arc. 2, Assay conltons Wavelength 540 nm (520-560) Temperature :37°C Cuvettelight path 1m 3. Adjustthe nstumentto zero wit distiled water. 4. Pipette intoacavette \Werking Reagent (a) (4R1:1R2): 1000 Calbratorsor sample (ui): 10 5, Mix and read the absorbance immediatly (1) and after 2 mites (2) ofthe sample addition ‘CALCULATION ‘One point Calibration: CORP (gil) = + Calibrator Concentration ‘QUALITY CONTROL It is recommended to use Quality Controls to verify the performance of the assay. Each Laboralory has to establish its own intemal qualty ‘control scheme and procedures fr corective action if controls do not recover withinthe acceptable tolerance REFERENCE VALUE It is recommended that each laboratory should establish its own reference values. The following value may be used. as. guideline ‘Serum: Normal values up to 8 mg/l. Results obtained for patient Samples are to be correlated with clinical findings of patient for interpretation and diagnosis, batePERFORMANCE 4. Lineaniy limit: Upto 110 mgIL, under tne described assay conditions. IF the concentration is greater than linearity (110 mgiL) dite the sample with normal saline ané repeat the assay. Muliply the resuitwith dation factor. 2. Detection limit: Values less than 2 mg/L give non-reproducile results, 3.Pro-zone effec: Nopro.zone effect was detected upon 1000 mgt 4 Sonsiviy:A42mA mg. 5 Precision Intra Run Inter Run Contral tow [Hien [tow | High a 20 20 20 | 20 Meanime/t) | 52 | 601 | 53 | 605 sD ou [| o9 | 016 | 10 evaom [27% | 15% | 30% [ 17% 6. Accuracy: Results obtained using this reagent (y) wore compared to those obtained using 2 commercial roagant (x) with similar characteristics, 50 samples of diferent concentrations of CRP were ‘assayed. The corelation coefficient (°) was 0.99 and the regression ‘equation was y = 0.968x + 1.197. The results ofthe performance characterises depend the analyzer used INTERFERENCE Blirubin (20 mg/dl), lipemia (10g/L) and rheumatoid factors (300 |UimL) do not interfere. Hemoglobin (> § gil), interferes. Other substances may interfere, NoTES. 1. The reagent systemis erin vito use only 21 The volume of reagents ana sample can be adjusted according to diffrent instruments, While the ratio ofthe reagensample shall be Manufactured By: HORIBA India Private Limited (subsidiary of HORUBA Limited Japan) Plot No,26, Sector-7, I.E, SIDCUL, Haridwar-249403, Uttarakhand, India Toll Free No.: 1800 103 4470 SCRE HORIBA