lab reagent Rapid test HCV Cassette device card Antibody to Hepatitis C Virus

CertificateGMPSFDAISO13485ISO9001:2008Hepatitis 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 over 80% of patients with well-documented non-A, non-B hepatitis.
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 antigens. Compared to the first generation HCV EIAs 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 tests.
HCV-Card Rapid Test(Serum/Plasma) is a rapid test to qualitatively detect the presence of antibody to HCV in serum or plasma specimen. HCV-Card Rapid Test is based on the principle of double antigen sandwich immunoassay for determination of anti-HCV in serum. The recombinant HCV proteins used in the test kit are encoded by the genes for both structural (nucleocapsid) and non-structural proteins.
Principle of the test
The HCV-Card Rapid Test (Serum/Plasma) is a qualitative, membrane based immunoassay for the detection of antibody to HCV in serum or plasma. The membrane is coated with recombinant HCV antigen on the test line region of the card. During testing, the serum or plasma specimen reacts with the recombinant HCV antigen coated colloidal gold. The mixture migrates upward on the membrane chromatographically by capillary action to react with another recombinant HCV antigen on the membrane and generate a colored line. Presence of this colored line indicates a positive result, while its absence indicates a negative result. To serve as a procedural control, a colored line will always appear at the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred.An internal procedure control has been incorporated into the test to ensure proper kit performance and reliability.
The use of a control is recommended to verify proper kit performance. Quality control samples should be tested according to quality control requirements established by the testing laboratory.