HAV IgM Rapid Test Cassette (Serum/Plasma)

Primary DI

D-GCHAV(IgM)-302BaVF

Basic UDI-DI Code

B-GCHAV(IgM)-302BaVF

Reference

GCHAV(IgM)-302Ba

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Zhejiang Orient Gene Biotech Co., Ltd

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.

Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).