Sell HCV Double antigens sandwich method rapid test

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INTENDED USE
THE RAPID ANTI-HCV TEST IS A COLLOIDAL GOLD ENHANCED, RAPID IMMUNOCHROMATOGRAPHIC ASSAY FOR THE QUALITATIVE DETECTION OF ANTIBODIES TO HEPATITIS C VIRUS (HCV) IN HUMAN SERUM OR PLASMA. THIS TEST IS A SCREENING TEST AND ALL POSITIVES MUST BE CONFIRMED USING AN ALTERNATE TEST SUCH AS WESTERN BLOT. THE TEST IS INTENDED FOR HEALTHCARE PROFESSIONAL USE ONLY.
SUMMARY
The general method of detecting infection with HCV is to observe the presence of antibodies to the virus by an EIA method followed by confirmation with Western Blot. The Rapid Anti-HCV Test is a simple, visual qualitative test that detects antibodies in human serum or plasma. The test is based on immunochromatography and can give a result within 15 minutes.
PRINCIPLE OF THE PROCEDURE
The assay starts with a sample applied to the sample well and add provided sample diluent immediately. The HCV antigen -colloidal gold conjugate embedded in the sample pad reacts with the HCV antibody present in serum or plasma sample forming conjugate/HCV antibody complex. As the mixture is allowed to migrate along the test strip, the conjugate/HCV antibody complex is captured by a antibody-binding protein A immobilized on a membrane forming a colored test band in the test region. A negative sample does not produce a test line due to the absence of colloidal gold conjugate/HCV antibody complex. The antigens used in the test are recombinant proteins corresponding to highly immunoreactive regions of HCV. A colored control band in the control region appears at the end of test procedure regardless of test result. This control band is the result of colloidal gold conjugate binding to an anti-HCV antibody immobilized on the membrane. The control line indicates that the colloidal gold conjugate is functional. The absence of the control band indicates that the test is invalid.
REAGENTS AND MATERIALS SUPPLIED
 Test cards/ test strips individually foil pouched with a desiccant.
 Sample Diluent
 Package Insert
MATERIALS REQUIRED BUT NOT PROVIDED
 Positive and negative controls
 Pipette to transfer 105l sample