Intended use

It is intended for screening and as an aid in the diagnosis of IgM antibodies to Hepatitis E Virus RNA (genotypes 1&4) in human serum or plasma.

Diagnostic Principle

1.  Microwell strips are pre-coated with anti-human IgM (μ chain) monoclonal antibody;

2.  Samples of blood serum or plasma are diluted and dripped to Microwell strip;

3.  When Hepatitis E Virus antibody is detected in samples, it will form a specific binding between anti-human IgM (μ chain) monoclonal antibody and HEV antibody;

4.  React with the added Hepatitis E virus antigen enzyme conjugate, different results will present different colors through enzyme substrate. The presence or absence of antibodies to hepatitis E virus is determined by the ratio of the OD of each sample on Microplate Reader.  

Storage

It should be stored at 2-8℃, kept from light. After opening the box, the unused reagents are stable if stored between 2-8℃ with desiccant and should be used up within one week. It’s stable if it’s transported in room temperature within a consecutive 5 days.