CRP Rapid POCT Test Kit High Sensitivity 20T Package By NIR-1000 Dry

【Product name】CRP.pdf

Diagnostic Kit for C-reactive Protein (Immunochromatographic assay)

【Package specification】

25 Tests/kit

【Intended use】

It is used for quantitative detection of C-reactive protein (CRP) in human serum, plasma and whole blood. CRP is mainly used as a non-specific inflammatory index.

【Test principle】

The kit is used the principle of fluorescence immunochromatography. The CRP antigen in the sample first combines with the fluorescent labeled CRP monoclonal antibody conjugate, and then continues to move and combine with another CRP monoclonal antibody fixed on the nitrocellulose membrane to form a double antibody sandwich immune complex at the detection line of nitrocellulose membrane. The quantitative detection results are obtained by NIR-1000 dry fluoroimmunoassay analyser.

【Storage conditions and validity period】

4℃ - 30℃, dry, dark, no freezing, sealed in aluminum foil bag, valid for 18 months. The test card should be returned to room temperature (15-30)℃ before use, and should be used within 15 minutes after unsealing under the environment of temperature (15-30) ℃ and relative humidity (20% - 90%).

The production date, batch number and expiration date are shown in the outer package of the product.

【Applicable instruments】

NIR-1000 dry fluoroimmunoassay analyser produced by WWHS Biotech. Inc.

【Sample requirements】

1. Serum and EDTA•Na2 anticoagulant plasma and whole blood, EDTA•K2 anticoagulant plasma and whole blood, sodium citrate anticoagulant plasma and whole blood can be used.

2. Venous blood was collected according to routine laboratory methods, and hemolysis was avoided as much as possible in the process of treatment.

3. After clinical samples were collected, the detection was completed within 4 hours at room temperature (15-30) ℃.The whole blood sample can be stored for 24 hours at (2-8)℃ without freezing; Serum and plasma samples can be stored for 7 days at 2-8℃;Serum and plasma samples - 20℃ for 30 days.

4. The sample must return to room temperature (15-30)℃ before testing. The frozen samples should be completely thawed, rewarming and mixed evenly before use, and repeated freezing and thawing should be avoided.

5. Do not test samples with severe hemolysis, severe lipidemia and jaundice.

【Reference interval】

252 healthy people aged 19-80 were tested. The upper limit of CRP reference value was 10mg/L at 95th percentile. Reference interval: CRP<10mg/L.

It is suggested that each laboratory should establish its reference range according to the characteristics of local population.

【Interpretation of test results】

1. This reagent is only used for auxiliary detection. If the test results are abnormal, it should be reviewed in time and judged in combination with clinical symptoms.

2. For samples with CRP concentration lower than 0.5mg/L and higher than 200mg/L, the test results were reported as "<0.5mg/L " and ">200mg/L" respectively.

【Limitations of test methods】

1. This kit is only used to detect human serum / plasma / whole blood samples.

2. Due to the limitations of serological methods for antigen and antibody reactions, the results obtained by detection cannot be used as the only basis for clinical diagnosis, but should be evaluated together with all existing clinical and experimental data.

3. The contents of triglyceride, hemoglobin and bilirubin in the samples were not more than 20 mg/ml, 10 mg/ml and 0.4 mg/ml, respectively, and the relative deviation of the test results was not more than 0.5%±10%.

4. When the concentration of C-reactive protein was less than 400 mg/L, there was no hook effect.

5. When the concentration of human anti mouse in the sample is less than 50ng/ml, HAMA effect will not be produced.

6. When the RF concentration in the sample is less than 2000 IU/ml, the relative deviation of the detection results is not more than±10%.

【Note】

1. The kit is only used for in vitro diagnosis.

2. The test card is disposable and cannot be reused.

3. Please check the integrity and validity of the kit package before use, and then open the package. When it is stored at low temperature, it should be restored to room temperature (15-30) ℃ before opening the package for use. The reagents with damaged inner package and beyond the validity period cannot be used.

4. The test card should be taken out from the aluminum foil bag and tested within 15 minutes to avoid being placed in the air for a long time and causing damp.

5. The requirements of specimen collection and storage should be strictly observed. If the specimen is turbid, it should be centrifuged and discarded before use.

6. The kit contains products from animals. The qualified information of animal source and health status cannot guarantee the existence of infectious pathogens. Therefore, it is suggested that these products should be treated as potential infectious substances, and all samples, reagents and potential pollutants should be disinfected and treated according to the relevant local regulations.

7. Hematocrit too high or too low may affect the results of whole blood test, it is recommended to use other detection methods for verification.