RAPID 1-2-3® HEMA EXPRESS® HEPATITIS C (HCV) TEST
INTENDED USE | The RAPID 1-2-3® HEMA EXPRESS® HEPATITIS C (HCV) TEST is a rapid qualitative test for the detection of antibodies specific to hepatitis-C virus in human whole blood, serum or plasma.
Hepatitis-C virus (HCV) is a small, enveloped, and single-stranded RNA virus. It is the major cause of parenterally transmitted non- A, non-B hepatitis. Antibodies to HCV are reported in 80% of non-A, non-B hepatitis patients. Recombinant HCV proteins consisting of the critical regions of the HCV virus including core, NS-3, NS-4 and NS-5, are used in this strip to detect HCV specific antibodies.
PRINCIPLES OF THE TEST
The RAPID 1-2-3® HEMA EXPRESS® HEPATITIS C (HCV) TEST is a lateral flow chromatographic immunoassay. The Test device consists of a test strip (dipstick) core component enclosed within a protective housing. The test strip is laminated to a sample collection pad. The test strip component of the test device contains a conjugate pad pre-coated with protein A gold conjugate, and a membrane (results window) containing a “Test (T) line” and a “Control (C) line”. The T line is striped with recombinant HCV proteins, and the C line is striped with rabbit anti-protein A antibodies.
When an appropriate amount of specimen is collected on the sample pad of the test device, the sample pad is inserted into the diluent pod, and the specimen/diluent mixture migrates by capillary action through the sample pad, into the housing and on to the test strip. The specimen/diluent mixture will first encounter the protein A gold conjugate pad where any specific anti-HCV antibodies as well as other non-specific antibodies present in the specimen will form complexes with the protein A gold conjugate. If the specimen contains no specific anti-HCV antibodies, only the nonspecific antibodies will complex with the protein A gold conjugate. The complexes will migrate further along the test strip next encountering the T line. If specific anti-HCV antibodies are present at a detectable level, the antibodies will bind to the recombinant HCV antigens applied at the test line and the “anti-HCV antibody – protein A gold conjugate” complex will be visibly deposited as a reddish-purple or burgundy line. If no anti-HCV antibodies are present in the specimen, no binding at the T line will occur and the specimen/diluent mixture will continue migrating along the membrane reaching the C line. The protein A gold conjugate will bind to the rabbit anti-protein A antibodies at the C line and will be deposited as a reddish-purple or burgundy line. The presence of both the T and C line indicates a positive result. The presence of only the C line indicates a negative result.