laboratory reagent Hepatitis A virus HAV IgM elisa test kit

ELISA Kit for Antibody IgM to Hepatitis A Virus(HAV)

CatalogNo. NAME PACKAGE SIZE:

BE301A ELISA Kit for Antibody IgM to Hepatitis A Virus (HAV) 96 tests/Kit

This test is a single use, rapid device intended for qualitativedetection of IgM-class antibodies to hepatitis A virus (HAV)in serum, plasma samples. It is intended tobe used in clinical laboratories for diagnosis of acutehepatitis A and management of patients related to infectionwith hepatitis A virus.

Hepatitis A is a self-limited disease and chronic stage or other complications are rare. Infections occur early in life in areas where sanitation is poor and living conditions are crowded. With improved sanitation and hygiene, infections are delayed and consequently the number of persons susceptible to the disease increases. Because the disease is transmitted through the fecal-oral route in dense populated regions, an outbreak can arise from single contaminated source. The cause of hepatitis A is hepatitis A virus (HAV)-non enveloped positive strand RNA virus with a linear single strand genome, encoding for only one known serotype. HAV has four major, structural polypeptides and it localizes exclusively in the cytoplasm of human hepatocytes. The infection with HAV induces strong immunological response and elevated levels first of IgM and then IgG are detectable within a few days after the onset of the symptoms. The presence of anti–HAV IgM is an important serological marker for early detection and observation of the clinical manifestation of the disease. Increasing levels of anti-HAV IgM are detectable about three weeks after exposure with highest titter after four to six weeks later. Within six months after infection IgM concentration declines to non-detectable levels.

This test employs chromatographic lateral flow device in acassette format. Colloidal gold conjugated recombinantantigens (Au-Ag) corresponding to HAV antigens aredry-immobilized at the end of nitrocellulose membrane strip.Anti-human IgM (anti-μ chain) are bond at the Test Zone (T)and goat anti-mouse IgG antibodies are bond at the ControlZone (C). When the sample is added, it migrates by capillarydiffusion rehydrating the gold conjugate. If present in sample,HAV IgM antibodies will bind with the gold conjugatedantigens forming particles. These particles will continue tomigrate along the strip until the Test Zone (T) where they arecaptured by anti-human IgM (anti-μ chain) generating a visible red line. If there are no HAV IgM antibodies in sample,no red line is formed in the Test Zone (T). The gold conjugatewill continue to migrate alone until it is captured in the ControlZone(C) by the goat anti-mouse IgG antibodies aggregating

in a red line, which indicates the validity of the test.

-Serum/plasma samples:

Fresh serum or plasma samples can be used. No special patient preparation required. Care should be taken to ensure blood full clotting and any visible particulate matter in the sample should be removed by centrifugation or filtration. Avoid the use of highly hemolytic, turbid, microorganism contaminated samples or samples stored for over 30days at 2-8°C. Store samples at 2-8°C. Samples not required for assay within 3 days should be stored frozen (-20°C or lower). Avoid sample deterioration by multiple freeze-thaw cycles.

-Plasma: Collect whole blood into a collection tube (containing EDTA, citrate or heparin, respectively) by venipuncture. Separate the plasma by centrifugation.

-Serum: Collect whole blood into a collection tube (containing no anticoagulants) by venipuncture. Allow the blood to clot. Separate by centrifugation.

The original samples cannot be tested directly, must be diluted with sample diluents before testing!

This test can be stored at room temperature (2-30°C, do not freeze!) for 18 months from the date of manufacture (see label on strip pouch). Use immediately after opening.