Hepatitis C Antibody Rapid Test Kits Suppliers & Bulk Manufacturers

Available Forms: Cassette-based lateral flow immunoassays/Test strip dipsticks

Available Strengths: >98% sensitivity and specificity

Reference Brands: -

Category: Rapid Test Kits

Hepatitis C antibody rapid test kits in cassette and dipstick formats for blood, serum, plasma or oral fluid, for hepatitis programmes, harm-reduction services, hospitals and IVD distributors.

Product Description:

Hepatitis C antibody rapid tests detect antibodies to hepatitis C virus in serum, plasma, fingerstick whole blood or, for some products, oral fluid. Recombinant HCV antigens on a lateral flow membrane capture the antibodies and form a test line. Cassettes with buffer and dropper and dipstick strips are both on offer. These are screening tests: a reactive result shows exposure to the virus at some point, not necessarily current infection.

With highly effective direct-acting antiviral treatment now widely available, WHO calls for broad testing to find people living with hepatitis C, and rapid tests take that to harm-reduction services, prisons, primary care and outreach. A reactive antibody result is followed by an HCV RNA or core antigen test to confirm active infection before treatment. Antibodies remain after successful treatment or spontaneous clearance, so the test is not used to follow up treatment or detect reinfection. Very recent infections can be missed before antibodies form.

Sourcing notes. Donor-funded buyers usually require WHO prequalification of the exact product. In the EU, HCV tests are Class D under the IVD Regulation, which brings notified-body review and batch verification. Ask for the instructions for use with performance data by sample type, independent evaluation results, the ISO 13485 certificate and lot release records. Check that the kit is validated for the sample your sites will collect, since oral fluid and fingerstick blood need their own data. Specify format, tests per kit, included lancets and buffer, shelf life and quantity.