RAPID CRP TEST STRIP
INTENDED USE
The Rapid CRP test strip is an immunochromatography based one step in vitro test. It is designed for semi-quantitative determination of C Reactive Protein (CRP) in human serum or whole blood specimens. The range of CRP concentration in serum can be detected in 10 minutes.
SUMMARY AND EXPLANATION
Produced by hepatocytes, C- reactive protein (CRP) is a non-specific, acute-phase reactant indicating acute injury, bacterial infection, inflammation. Recent studies have found that CRP is also an indicator of myocardial infarction. Elevated levels of CRP are also a good predictor of future cardiac diseases. Although the detection of elevated levels of CRP in the serum is not specific for any particular disease, it is a useful indicator of inflammatory processes. CRP levels rise in serum or plasma within 24 to 48 hours following acute tissue damage, reach a peak during the acute stage (approximately 1000x constitutive level) and decrease with the resolution of inflammation or trauma. The concentration increase of CRP in human serum or plasma may last for several days before decreasing to normal levels. As elevated CRP values are always associated with pathological changes, the CRP assay provides useful information for the diagnosis, therapy and monitoring of inflammatory processes and associated disease. Additionally, measurement of CRP may add to the predictive value of other cardiac markers (myoglobin, creatine-kinase-MB, troponin I and T), which are used to assess the risk of cardiovascular and peripheral vascular disease. As increases in CRP values are non-specific, they should not be interpreted without a complete patient history evaluation, and measurements of CRP should be compared to previous values.
TEST PRINCIPLE
Rapid CRP Test Strip
Rapid CRP test strip is based on the principle of specific immunochemical reaction between antibodies and antigens to analyze particular compounds in human serum specimen. The CRP test assay relies on the competition for binding antibody between CRP-dye conjugate and free CRP which may be present in the specimen being tested. When CRP is present in the specimen, it competes with CRP-dye conjugate for the limited amount of antibody coated on the test band zone. When the amount of CRP is equal or more than the 10 μg/mL, it will prevent the binding of CRP-dye conjugate to the antibody. Therefore, there will be no colored band on the test line zone.
A control line is present in the test window to work as procedural control and as reference. This colored band should always appear on the control line zone if the test device is stored in good condition and the test is performed appropriately.
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