CDIA™ Hepatitis E Virus IgM Test Kit - Creative Diagnostics

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Infectious Disease Tests | Hepatitis E Virus |

CDIATM Hepatitis E Virus IgM Test Kit (DTS773)

* For research use only, not for use in diagnostic procedures.

Intended Use

This test is a single use, rapid device intended for qualitative detection of IgM-class antibodies to hepatitis E virus (HEV) in serum, plasma or whole blood 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.
  • Serum, whole blood, plasma
  • Kit

Product Introduction

General Description
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 casefatality 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, zoonosisrelated studies and vaccine development.
Principle Of The Test
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 IgM (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 IgM 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 IgM (anti-μ chain) generating a visible red line. If there are no HEV IgM 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.

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