KFDA Registration No :   14-3015
   CAT No :   DEH007
   SAMPLE VOLUME :   10 ul
   INCUBATION TIME :   60'+30'+30'RT
   STD RANGE :   Qualitative

Intended Use

Enzyme-Linked Immunosorbent assay for qualitative determination Antibody to Hepatitis C Virus (Anti-HCV) in human serum or plasma


Because of the absence of serological markers, blood screening test for blood-borne, non-A, non-B hepatitis were not available in the past. It was not until 1989, when Choo et al. cloned cDNA segments of the non-A, non-B hepatitis virus (designated Hepatitis C virus, HCV) from infectious chimpanzee plasma, that this became applicable. Hepatitis C is a disease caused by viral infection, which is primarily a result of blood transfusion or improper needle punctures. According to report studies prior to 1980, the risk of post-transfusion hepatitis was estimated to be 7 to 12%, with approximated 90% of post-transfusion hepatitis being caused by the NANB hepatitis agent. Other reports estimated that 5 to 10% of transfused individuals will develop acute NANB hepatitis, with 40% to 60% progressing to become chronic NANB hepatitis and carriers. Recently, the post-transfusion, NANB hepatitis agent, which also spreads through non-transfusion routes, was definitively named hepatitis C virus based on knowledges obtained with genetic engineering techniques. Since hepatitis C is a significant problem for public health management, screening for hepatitis C, therefore, is urgently needed.

Principle of the Assay

The DIAKEY Anti-HCV IRMA is an two step non-competitive enzyme-linked immunosorbent method. The method employs one the 3rd generation recombinant HCV Antigen (Core, NS3, NS4-2 and NS5). The recombinant antigen is coated on solid phase (coated well) and recombinant protein-A labeled with HRP, is used as a tracer. Antigen-coated polystyrene wells serve as solid phase. The tracer antigen and the coated antigen react simultaneously with the Anti-HCV present in the control or serums.

Handling Precaution

  • Do not use mixed reagents from different lots.
  • Do not use reagents beyond the expiration date.
  • Use distilled water stored in clean container.
  • Use an individual disposable tip for each sample and reagent, to prevent the possible cross-contamination among the samples.
  • Rapidly dispense reagents during the assay, not to let wells dry out.

Use Precaution

  • Wear disposable globes while handling the kit reagents and wash hands thoroughly afterwards.
  • Do not pipette by mouth.
  • Do not smoke, eat or drink in areas where specimens or kit reagents are handle.
  • Handle samples, reagents and loboratory equipments used for assy with extreme care, as they may potentially contain infectious agents.
  • When samples or reagents happen to be spilt, wash carefully with a 1% sodium hypochlorite solution.
  • Dispose of this cleaning liquid and also such used washing cloth or tissue paper with care, as they may also contain infectious agents.
  • Avoid microbial contamination when the reagent vial be eventually opend or the contents be handled.
  • Use only for IN VITRO.