KFDA Registration No :   14-3034
   CAT No :   RH03
   TEST METHOD :   IRMA
   SAMPLE VOLUME :   10 ul
   INCUBATION TIME :   60'+60'RT
   STD RANGE :   Qualitative

Intended Use

Immunoradiometric assay for qualitative determination Antibody to Hepatitis A Virus IgM (Anti-HAV IgM) in human serum or plasma.

Principle of the Assay

The RIAKEY Anti-HAV IgM IRMA is an two step non-competitive immunoradiometric (IRMA) method. During the first reaction, Anti-HAV IgM in sample combine Antihuman IgM coated in tube. The complex Anti HAV IgM-Anti Human IgM combine HAV Antigen and anti-HAV IgM labelled with 125I in the second reaction. Unbounded material is removed by a washing step. The amount of the complex is directly proportional to the amount of HAV IgM antibody in sample. Concentration is calculated by measuring the amount of radioactivity using gamma counter.

  • 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.
  • Store the unused coated tubes at 2~8ºC in the appropriate bags with silica gel and accurately sealed.
  • If large quantity of assay would be performed at one time, there might be substantial time variation between 60 tubes at one time to minimize time variation. Also, do not exceed 10 minutes for entire pipetting.
  • 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 split, wash carefully with a 3% 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.