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.