1 x 50/1 x 20 mL

CRP 12016041

Intended Use Reagents required but not provided

Agappe CRP Calibrator (Product Code: 11616001)
This reagent is intended for in vitro quantitative determination of C-reactive
protein in human serum. Agappe Protein Control (Product Code: 11614006)
- Latex enhanced immunoturbidimetry
Calibration
- Linear up to 200 mg/L Agappe CRP Calibrator(Product Code:11616001) is recommended for calibration
- Ready to use reagents of the assay.
Preparation of Calibration Curve
Clinical Significance
CRP (C – Reactive Protein) is a cytokine - induced, acute phase protein that Prepare the following calibrator dilution using Normal saline as diluent. Multiply
the concentration of the CRP Calibrator by the corresponding factors stated in the
increases in concentration as a result of inflammation. CRP levels in the body has
table below to obtain the CRP concentration of each dilution.
been used as a marker or indicator of infections and inflammation. The assay of
CRP is more sensitive than the erythrocyte sedimentation rate (ESR) and leukocyte Dilution 1 2 3 4 5 6
count. The CRP levels rise and return to reference ranges more rapidly after the Cali. (µL) - 10 10 20 50 100
disease has subsided. Normal Saline (µL) 100 150 70 60 50 -
Dil. factor 0 0.0625 0.125 0.25 0.5 1.0
Principle
This is a latex enhanced turbidimetricimmuno assay. CRP in the samples binds to Quality Control
specific anti-CRP antibodies, which have been adsorbed to latex particles and It is recommended to use Agappe Protein Control (Product Code: 11614006) to
agglutinates. The agglutination is proportional to the quantity of CRP in the verify the performance of the assay.
sample. The actual concentration is then determined by interpolation from a Each Laboratory has to establish its own internal quality control scheme and
calibration curve prepared from calibrators of known concentrations. procedures for corrective action if controls do not recover within the acceptable
tolerance.
Kit Components
Reagent/ Product Code Description Reference Range
Component 12016041 It is recommended that each laboratory should establish its own reference values.
The following value may be used as guide line.
CRP R1 1 x 50 mL Glycine buffer solution
Serum : 6 mg/L
Results obtained for patient samples are to be correlated with clinical findings of
CRP R2 1 x 20 mL Latex suspension coated with anti-CRP
patient for interpretation and diagnosis.
antibodies. (rabbit polyclonal antibody)
Performance
Risk & Safety
1. Linearity
Material Safety data sheets (MSDS) will be provided on request
The reagent is linear up to 200 mg/L. If the concentration is greater than linearity
Reagent Preparation (200 mg/L), dilute the sample with normal saline and repeat the assay. Multiply
CRP R1 & R2 Reagents are ready to use. the result with dilution factor.
2. Comparison
Reagent Storage and Stability A comparison study has been performed between Agappe reagent and another
The sealed reagents are stable upto the expiry date stated on the label, when stored internationally available reagent yielded a correlation coefficient of r2= 0.9998
at 2-8OC. and a regression equation of y = 1.0676x.
3. Precision
Open Vial Stability
Once opened the reagents are stable up to 30 days if contamination is avoided. Intra Run (Sample) Inter Run (Control)
Sample 1 Sample 2 Level 1 Level 3
On-board Calibration Stability
n 20 20 20 20
Calibration is stable for 20 days.
Mean (mg/L) 4.48 36.69 6.36 43.62
Reagent Deterioration SD 0.06 0.44 0.08 0.72
Turbidity or precipitation in any kit component indicates deterioration and the CV(%) 1.45 1.2 1.27 1.64
component must be discarded. Values outside the recommended acceptable range
for the Agappe Protein Control may also be an indication of reagent instability
and associated results are invalid. Sample should be retested using fresh vial of Accuracy (mg/L)
reagent.
Control Expected Value Measured Value
Precaution Control Level 1 6.04 ±1.34 6.38
To avoid contamination, use clean laboratory wares. Close reagent bottles Control Level 3 43.4 ±8.9 44.18
immediately after use. Avoid direct exposure of reagent to light. Do not blow into
the reagent bottles. 4. Sensitivity
This reagent is only for IVD use and follow the normal precautions required for Lower detection Limit is 1 mg/L
handling all laboratory reagents.
Bibliography
Waste Management
1. Tillett.W.S..et al: Serological reactions in pneumonia with a non protein somatic
Reagents must be disposed off in accordance with local regulations.
fraction of pneumococcus.J.Exp.Med..52,561(1930).
Sample
Fresh Serum. Do not use lipemic or hemolysed sample. 2. ZeigenhagenG,DrahovshyD.KlinisheBedeutungdes C-reaktivenprotein.Med klin
Interferences 1983;78:45-50.
No interference for 3. Rifal.N.Tracy.R.P.Rid ker,P.M.Clinical efficacy of an Automated High sensitivity
Hemoglobin up to 500 mg/dL
C-Reactive protein Assay: Clin chem. 45-12.
Intrafat up to 500 mg/dL
Bilirubin up to 30 mg/dL
Rheumatoid Factor up to 500 IU/mL

Materials provided
CRP R1 & R2 Reagent

SYMBOLS USED ON THE LABELS

IN VITRO DIAGNOSTIC USE SEE PACKAGE INSERT FOR PROCEDURE LOT NUMBER MANUFACTURER’S ADDRESS MANUFACTURING DATE EXPIRY DATE TEMPERATURE LIMIT

AGAPPE DIAGNOSTICS LTD.

Agappe Hills, Dist. Ernakulam, Kerala, India-683 562.
Customer Care No. +91 484 3120002 ISO 9001:2008
customercare@agappe.in | www.agappe.com REV. NO.: ADL/IFU/CRP/BS2/R00 EN ISO 13485:2012