medical laboratory kit IgM Antibody HEV

CertificateGMPSFDAISO13485ISO9001:2008
ELISA Kit for Antibody to Hepatitis E Virus (HEV)
CatalogNo. NAME PACKAGE SIZE:
BE402A ELISA Kit for Antibody IgM to Hepatitis E Virus (HEV)96 tests/KitThis test is a single use, rapid device intended for qualitative detection of IgG-class antibodies to hepatitis E virus (HEV) in serum, plasma samples. It is intended to be used in clinical laboratories for diagnosis of acute hepatitis E and management of patients related to infection with hepatitis E virus.Hepatitis E virus (HEV) is a non-enveloped; single- stranded RNA virus identified in 1990. Infection with HEV induces acute or sub-clinical liver diseases similar to hepatitis A. HEV infections, endemic and frequently epidemic in developing countries, is seen also in developed countries in a sporadic form with or without a history of traveling to endemic area. The overall case-fatality is 0.5~3%, and much higher (15~25%) among pregnant women. A hypothesis that
HEV infection is a zoonosis was presented in 1995. Then a swine HEV and later an avian HEV were identified and sequenced separately in 1997 and 2001. Since then, HEV infection include anti-HEV, viremia and feces excretion of HEV was seen in a wide variety of animals, i.e., swine, rodents, wild monkeys, deer, cow, goats, dogs and chicken in both the developing and developed countries. A direct testimony was reported that the consumption of uncooked dear meat infected with HEV led to acute hepatitis E in human. And HEV genome sequences can be detected in pork livers available in the supermarkets in Japan.
With the discovery of conformational epitopes in HEV, HEV serology was further explored and understood. The phenomenon of long-lasting and protective antibodies to HEV was observed which greatly enhance the understanding to the diagnosis, epidemiology, zoonosis-related studies and vaccine development.
PRINCIPLE OF THE ASSAY
This test employs chromatographic lateral flow device in a cassette format.Colloidal gold conjugated recombinant antigens (Au-Ag) corresponding to HEV antigens are dry-immobilized at the end of nitrocellulose membrane strip.Anti-human IgG (anti-μ chain) are bond at the Test Zone (T) and goat anti-mouse IgG antibodies are bond at the Control Zone (C). When the sample is added, it migrates by capillary diffusion rehydrating the gold conjugate. If present in sample, HEV IgG antibodies will bind with the gold conjugated antigens forming particles. These particles will continue to migrate along the strip until the Test Zone (T) where they are captured by anti-human IgG (anti-μ chain) generating a visible red line. If there are no HEV IgG antibodies in sample, no red line is formed in the Test Zone (T). The gold conjugate will continue to migrate alone until it is captured in the Control Zone(C) by the goat anti-mouse IgG antibodies aggregating in a red line, which indicates the validity of the test.
COMPONENTS
Forty tests/kit
20 HEV IgM colloidal gold rapid test strips, each placed in white plastic cassette and packed in foil pouch, Instructions for Use, 5mlx1 dilution tubes.
Materials required but not provided: Safety lancet, alcohol Prep-Pad, Disposable Pipette, clock or timer, specimen collection container, centrifuge, biohazard waste container
SPECIMEN COLLECTION
Wash your hands with soap and warm water. Choose a puncture site on the fingertip. Clean the fingertip with Alcohol Prep Pad. Place a Safety Lancet on a selected puncture site. Forcefully press the tip of the Safety Lance against your fingertip. Wipe away the first drop of blood with sterile gauze or cotton. Using Disposable Pipette, collect blood from the puncture site. Alternatively - draw blood following laboratory procedure for obtaining venous blood.