Mindray Antibody to Hepatitis C Virus (Anti-HCV) CLIA Reagent Kit

Mindray Antibody to Hepatitis C Virus (Anti-HCV) CLIA Reagent Kit is a chemiluminescence immunoassay designed for the qualitative determination of antibodies to Hepatitis C Virus in human serum or plasma using compatible Mindray CL-series immunoassay analyzers. Mindray includes Anti-HCV in its infectious-disease CLIA assay portfolio. The assay uses recombinant HCV antigens to capture antibodies present in the patient sample. Detection of Anti-HCV is used as an aid in identifying individuals who may have been exposed to or infected with Hepatitis C Virus. A reactive antibody result indicates exposure to HCV but should be followed by appropriate confirmatory or nucleic-acid testing according to the laboratory's testing algorithm. Mindray states that its Anti-HCV assay can detect both IgG and IgM antibodies and uses specially designed recombinant antigen sequences to improve antibody binding. The assay received EU IVDR Class D certification in 2023. Key Features - Qualitative detection of Antibody to Hepatitis C Virus - Commonly identified as Anti-HCV - Detects antibodies associated with HCV infection - Uses chemiluminescence immunoassay technology - Two-step sandwich immunoassay principle - Detects both IgG and IgM Anti-HCV antibodies - Suitable for human serum or plasma - Compatible with Mindray CL-series CLIA analyzers - Sample volume approximately 20 µL per test - Available in 2 × 50 tests and 2 × 100 tests - Liquid, ready-to-use reagent system - Onboard stability up to 28 days at 2–8°C - Intended for hepatitis C screening and diagnostic support - IVDR Class D certified assay