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RIAKEY Anti-HBs IRMA Tube

  BASIC INFORMATION   USE PRECAUTION
   KFDA Registration No :   14-3139
   CAT No :   RH02AN
   TEST METHOD :   IRMA
   SAMPLE VOLUME :   50 ul
   INCUBATION TIME :   90'RT
   STD RANGE :   0-1000 mIU/ml

Intended Use

Immunoradiometric assay for quantitative and/or qualitative determination of Antibody to Hepatitis B Virus surface antigen (Anti-HBs) in human serum or plasma

Introduction

In 1965, Dr. Blumberg who was studying hemophilia, found an antibody in two patients which reacted against an antigen from an Australian Aborigine. Later the antigen was found in patients with serum type hepatitis and was initially designated "Australian Antigen". Subsequent study has shown the Australian Antigen to be the hepatitis B surface antigen (HBsAg, HBs Antigen). Initially there appeared to be three particles associated with hepatitis B infection: a large "complete" particle called the "Dane particle", a small circular 22 nm particle and an oblong 42 nm C particle. Further research identified the Dane particle as the hepatitis B virion and the other two particles as excess surface protein. This former terminology is no longer used and the virus is referred to according to its structure. Subsequent association with hepatitis B virus (HBV) led to the development of sensitive, specific markers of HBV infection. During acute and chronic HBV infection, HBsAg is produced in excess amounts, circulating in blood as both 22 nm spherical and tubular particles. HBsAg can be identified in serum 30~60 days after exposure to HBV and persists for variable periods depending on the resolution of the infection. Antibody to HBsAg (anti-HBs) develops after a resolved infection and is responsible for long-term immunity. Anti-HBc develops in both resolved acute infections and chronic HBV infections and persists indefinitely. Immunoglobulin M (IgM) anti-HBc appears early in infection and persists for greater than or equal to 6 months. It is a reliable marker of acute HBV infection.
** Modes of Transmission: Transmission of HBV occurs via percutaneous or permucosal routes, and infective blood or body fluids can be introduced at birth, through sexual contact or by contaminated needles. Infection can also occur in settings of continuous close personal contact (such as in households or among persons in institutions for the developmentally disables), presumably via inapparent or unnoticed contact of infective secretions with skin lesions or mucosal surfaces.

Principle of the Assay

The RIAKEY Anti-HBs IRMA Tube is an one step non-competitive immunoradiometric assay (IRMA) method (“sandwich”). The method employs two recombinant HBsAg. One antigen is coated on solid phase (coated tube), the other, specific for the Anti-HBs and labeled with Iodine-125, is used as a tracer. Recombinant HBsAg-coated polystyrene tubes serve as solid phase. The tracer antigen and the coated antigen react simultaneously with the Anti-HBs antibody present in the standards, control serum and samples. Unbound material is removed by a washing step. The amount of bound tracer will be directly proportional to the Anti-HBs antibody concentration and the remaining radioactivity bound to the tubes is measured in a gamma scintillation 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.