CRP Turbilatex

Description

Code : AGD-CRPT50.

Pack Size : R1-1X40mL R2-1X10mL .

CRP Calibrator -1X1mL

C-Reactive Protein is a non-specific acute phase reactive protein which appears in the blood during an inflammatory process. In patients with inflammatory diseases the concentration of CRP increases and decreases more quickly than the red cells sedimentation rate.

Intended use :

Latex enhanced immuno-turbidimetric test for the quantitative measurement of C-reactive protein in human serum or plasma.

Clinical Significance :

C- Reactive Protein is a non-specific acute phasereactive protein which appears in the blood during an inflammatory process. In patients with inflammatory diseases the concentration of CRP increases and decreases more quickly than the red cells sedimentation rate. CRP lacks diagnostic value when the patients illness is not defined, but it is very useful for following-up inflammatory diseases, as well as for the differential diagnosis in certain cases.

Principle :

The reagent consists of a suspension of latex particles of homogeneous size sensitized with anti-CRP, capable of aggregation in the presence of CRP. This aggregation process produces an increase in the size of the latex particles which in turn produces an increase in the absorbance of the system.

Sample :

Serum and plasma may be used. The isolated serum (plasma) should be tested on the same day. If samples cannot be measured on the same day,freeze it at below -200C. Bring samples to room temperature (15 – 300C ) before use.

Interfering substances:

No interference was observed by Bilirubin (171 µmol/L), Hemoglobin (5g/L), Triglycerides (2.28 mmol/L), RF(210 IU/mL) other drugs and substances may interfere in the test.

Reagents composition:

R1- CRP Buffer:-  Phosphate buffer 100 mM, pH 6.5 sodium azide 0.9 g/l.

R2 – CRP Latex:-  Suspension of Latex particles sensitized with anti-human CRP, sodium azide 0.9 g/l CRP Calibrator:-  Printed on the label of vial

Before using this product, gently invert the CRP Latex Solution R2 bottle to mix it thoroughly, and check that there are no bubbles.

Storage and Shelf Life : Storage temperature: 2-8ºC

Shelf life: (The expiration date is printed on the kit label.)

Procedure : For Semi Automated Analyzer

• Procedure with 1- point calibrationThe samples and reagents should be brought to roomtemperature prior to use.

Reagent       Calibrator(C)        Test (T)

R1                     400µL.                 400µL

R2                    100µL.                   100µL

Calibrator            5µL                        –

Sample               –                               5µL

Calculations : Calculate ∆A (A2-A1). Plot a spline calibration curve using 0 Concentration (saline) and 5 dilutions of CRP Calibrator. Measure concentration of controls, samples.

Linearity: Reagent is linear up to 150mg/L. Dilute the sample appropriately and re-assay if CRPConcentration exceeds 150mg/L.Multiply the result withdilution factor.

Calibration :

1- point calibration : CRP Concentration (mg/L) =

Absorbance of sample/Absorbance of Calibrator     X      Concentration of Calibrator

Multi point calibration:

Calculate ∆A (A2-A1). Plot a spline calibration curve using 0 Concentration (saline) and 5 dilutions of CRP Calibrator. Measure concentration of controls, samples. Calibration :

Quality Control : To ensure adequate quality control, it is recommended that the laboratory should use a normal and abnormal commercial reference control serum. Please note that the quality control material is used to check the function of reagents and the machine together.

Normal Reference Range : 0 -10 mg/L in healthy individuals with no signs of infectionor inflammation.

The kit is for in vitro diagnostic use only. Not for use in humansor animals. The instruction must be followed to obtain accurate results.Do not use the reagents beyond the expiration date.Treat all specimens as infectious. Proper handling and disposalprocedure of specimens and the test, materials should bestrictly followed