HCV Rapid Test Cassette
Product background
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 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.
The HCV Rapid Test Cassette (Whole Blood/Serum/Plasma) is a rapid test to qualitatively detect the presence of antibody to HCV in a whole blood, serum or plasma specimen. The test utilizes colloid gold conjugate and recombinant HCV proteins to selectively detect antibody to HCV in whole blood, serum or plasma. The recombinant HCV proteins used in the test kit are encoded by the genes for both structural (nucleocapsid) and non-structural proteins.
Intended use
The HCV Rapid Test Cassette (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of antibody to Hepatitis C Virus in whole blood, serum or plasma.
Operation steps and result interpretation
(Please refer to the illustration above)
POSITIVE: * Two distinct colored lines appear. One color line should be in the control region (C) and another color line should be in the test region (T).
*NOTE:The intensity of the color in the test line region (T) will vary depending on the concentration of HCV antibodies present in the specimen. Therefore, any shade of red in the test region should be considered positive.
NEGATIVE: One color line appears in the control region (C). No apparent red or pink line appears in the test region (T).
INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test cassette. If the problem persists,discontinue using the test kit immediately and contact your local distributor.