INTENDED USE

The CRP Rapid Test Device (Whole Blood/Serum/Plasma) is used for semi-quantitative determination and monitoring of CRP concentrations in whole blood/serum/plasma specimens.

SUMMARY

C-­reactive Protein (CRP) in patient’s sera has been found in association with acute infections, necrotic  conditions  and  a  variety  of  inflammatory  disorders.  There  is  a  strong  correlation  between serum levels of CRP and the onset of the inflammatory process. Monitoring the levels of CRP in patient’s sera indicates the effectiveness of treatment and the assessment of patient recovery. It is used in particular to differentiate bacterial infections from virus infections.

PRINCIPLE

The CRP Rapid Test Device (Whole Blood/Serum/Plasma) detects C-reactive Protein through visual interpretation of color development on the internal strip. Anti-CRP antibodies are immobilized on the test region of the membrane. During testing, the specimen reacts with anti-CRP antibodies conjugated to colored particles and precoated on the sample pad of the test. The mixture then migrates through the membrane by capillary action, and interacts with reagents on the membrane. If the intensity of the test band is weaker than reference band (R), it indicates that the CRP level in the specimen is between 10~30 mg/L. If the intensity of the test band (T) is stronger than the reference band (R), it indicates that the CRP level is above 30 mg/L. The appearance of control line serves as a procedural control, indicating that the proper volume of specimen has been added and membrane wicking has occurred.