タイトルまたは説明

INTENDED USE
One-Step anti-HCV Rapid Test is a rapid, one-step, visual test for the qualitative detection of antibodies specific to the Hepatitis C virus i in whole blood,serum or plasma.
It is intended to be used as an aid in the diagnosis of infection with HCV.

.PRINCIPLES OF THE TEST
One-Step Anti-HCV Rapid Test is based on the principle of agglutinating sera on membrane and utilizes the principle of lateral flow immunochromatography, a unique two site, double antigen sandwich immunoassay on a membrane.There are two regions, test region and control region, an the membrane of the test strip.
The test strip consists of: 1) a burgundy colored conjugate pad containing HCV antigen (multiple epitope HCV recombinant peptide) conjugated with colloid gold and and mouse IgG conjugated with colloid gold, 2) a nitrocellulose membrane strip containing a test band (T band) and a control band (C band). The T band is pre-coated with non-conjugated HCV antigen (multiple epitope HCV recombinant peptide), and the C band is pre-coated with goat anti-mouse IgG antibody.
As the test specimen/buffer mixture flows through the membrane assembly of the device, the HCV antigen colloidal gold conjugate complexes with the Anti-HCV in the test specimen and travels on the membrane due to capillary action along with the mouse IgG colloidal gold conjugate. This complex moves further on the membrane to the test region (T) where it is immobilized by HCV antigen coated on the membrane, leading to formation of a pink/purple colored band. The formation of first purple region (T) confirms a positive test result. Absence of this colored band  in the test region (T) indicates a negative test result
The mouse IgG colloidal gold conjugate moves further on the membrane and are subsequently immobilized by the goat anti mouse IgG antibodies coated on the membrane at the control region (C) forming a pink / purple colored band. This control band acts as a procedural control and serves to validate the test results.