INTENDED USE

The HCV Hepatitis C Virus Rapid Test Dipstick (Whole Blood/Serum/Plasma) is a single use, visually read, rapid chromatographic immunoassay for the qualitative detection of antibodies to Hepatitis C Virus in human venous and capillary whole blood, serum or plasma. The test is intended to be used as an aid in the diagnosis of individuals at risk of Hepatitis C infection.
The test provides preliminary results. Negative or positive results do not preclude Hepatitis C infection and may need to be confirmed using other methods according to current guidelines.
The HCV Hepatitis C Virus Rapid Test Dipstick (Whole Blood/Serum/Plasma) is not automated and is intended for professional use in a laboratory or near patient environment. This test Dipstick is not intended for self-testing or testing in infants younger than 18 months of age and must not be used for blood donation screening.

SUMMARY

Hepatitis C Virus (HCV) is a small, enveloped, positive-sense, single-stranded RNA Virus. HCV is now known to be the major cause of parenterally transmitted non-A, non-B hepatitis. Antibody to HCV is found in most patients with well-documented non-A, non-B hepatitis1.
Conventional methods fail to isolate the virus in cell culture or visualize it by electron microscope. Cloning the viral genome has made it possible to develop serologic assays that use recombinant antigens2. Compared to the first generation HCV EIA using single recombinant antigen, multiple antigens using recombinant protein and/or synthetic peptides have been added in new serologic tests to avoid nonspecific cross-reactivity and to increase the sensitivity of the HCV antibody tests3.
The HCV Hepatitis C Virus Rapid Test Dipstick (Whole blood/Serum/Plasma) is a rapid test to qualitatively detect the presence of antibody to HCV in a serum or plasma or whole blood specimen. The test utilizes a combination of recombinant HCV antigen coated particles and recombinant HCV proteins to selectively detect antibody to HCV in serum or plasma or whole blood. The recombinant HCV antigens used in the test kit are encoded by the genes for both structural (nucleocapsid) and non-structural proteins.

PRINCIPLE

The HCV Hepatitis C Virus Rapid Test Dipstick (Whole blood/Serum/Plasma) is a qualitative, membrane based immunoassay for the detection of antibody to HCV in serum or plasma or whole blood. The membrane is coated with recombinant HCV antigen on the test line region of the Dipstick. During testing, the serum or plasma or whole blood specimen reacts with the recombinant HCV antigen coated particles. The mixture migrates upward on the membrane by capillary action to react with recombinant HCV antigen on the membrane and generates a colored line. Presence of this colored line indicates a reactive result, while its absence indicates a non-reactive result. To serve as a procedural control, a colored line will always appear in the control line region. If the control line does not appear, the test result is invalid.