C-reactive protein rapid test kits
NOVA Test ® One Step C-Reactive Protein (CRP) Test kit is intended to be used as an aid in evaluating the risk of myocardial infarction (heart attack) and early detection of coronary cardiac diseases.
Intended Use
NOVA Test ® One Step C-Reactive Protein (CRP) Test kit is a rapid and convenient immunochromatographic assay kit for the qualitative detection of CRP in human serum or plasma samples at the cut-off value of 3 μg/ml. It is intended for professional use as an aid in evaluating the risk of myocardial infarction (heart attack) and early detection of coronary cardiac diseases. This CRP rapid test kit provides only a preliminary result. Clinical expertise and professional judgment should be sought to further evaluate the results of the test.
Although the C-reactive protein rapid test kit demonstrates superior accuracy in detecting C-reactive protein, a low incidence of false results can occur. Therefore, other clinically available tests are required in case of questionable results. As with all diagnostic tests, a definitive clinical diagnosis should not be based on the results of a single test, but should only be made by the physician after all clinical and laboratory findings have been evaluated.
Trueness of CRP as indicator of inflammation
C-reactive protein (CRP) is a sensitive, nonspecific systemic marker that is produced in the liver and released into blood circulation in response to inflammation. The increased CRP level is not specific to any one disease, but has been linked to a number of diseases including serious infections of bacteria, virus, fungi and parasites, lupus, rheumatoid arthritis and other acute and chronic inflammatory diseases.
It is well established that inflammation is a significant indicator of coronary heart disease and the C-reactive protein test, though not condition specific, can be used as an aid in evaluating the risk of myocardial infarction (heart attack) and early detection of coronary cardiac diseases. During an inflammatory process, the CRP level rises dramatically. CRP concentration can rise from a basal level of 1 to 3 µg/ml to 500 µg/ml within hours of inflammation onset. Monitoring the elevation of C-reactive protein level is thus widely used as an indicator of inflammatory diseases.
Quality control of CRP test kit
As an immunochromatographic rapid test kit, the NOVA test ® C-reactive protein test device contains an internal quality control, it is the control band (C line), where a pink colored band should always appear, indicating that enough specimen has been added, and the reagents of the CRP test kit has not deteriorated. If no visible band appear at the control region, the test is invalid. The testing process should be repeated with with a new test device. In this way, it is assured that if the test kit failed to give correct testing result, the performer of the C-reacting protein test should know it.
Meanwhile, a good laboratory practice recommends the daily use of an outside control to ensure proper testing device performance. Quality control samples should be tested according to the standard quality control requirements established by of the respective clinical laboratory.
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