HEV ANTIBODY IGM

Primary DI

06936791020054

Basic UDI-DI Code

B-06936791020054

Reference

WG0301-20

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Zhongshan Bio-Tech Co., Ltd.

This reagent kit is intended for use of in vitro qualitative test of IgM antibody to HEV in human serum or plasma samples. The test results are for clinical reference only and cannot be used alone as a basis for confirming or excluding cases. Hepatitis E (HE) is an acute viral hepatitis caused by Hepatitis E Virus (HEV), which is a human-animal disease(or zoonosis). HEV, 27-34 nm in size, is a single-stranded and positive-stranded RNA virus without envelope or capsule. HE is mainly transmitted by the fecal-oral route, with an incubation period of 2 to 9 weeks, averaging about 40 d. Most of them are self-limiting, with clinical manifestations similar to those of other acute viral hepatitis. Initial symptoms are nonspecific (e.g., weakness, anorexia, muscle pain, arthralgia, and vomiting), and some patients present with jaundice, pruritus, and darkened urine, accompanied by elevated transaminases, bilirubin, alkaline phosphatase, and γ-glutamyl transferase. The human body is universally susceptible to HEV, and people of all ages can be infected and develop the disease. Populations such as food workers (including livestock farmers and caterers), military personnel, field workers, college students, and workers or business travelers in infected areas are at higher risk of HEV infection due to greater exposure to the pathogen.

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