HEV IgM Rapid Test

Intended Use

HEV IgM Rapid Test (Whole blood/Serum/Plasma) is an in vitro diagnostic rapid immunochormatographic assay for the qualitative detection of specific anti-HEV IgM in human whole blood, serum and plasma specimens. HEV IgM Rapid Test may be used as an aid in the diagnosis of hepatitis E. A reactive result should be confirmed by other supplemental assay(s).

Introduction

Hepatitis E is inflammation of the liver caused by infection with the hepatitis E virus (HEV).1 It is spread by fecally contaminated water within endemic areas or through the consumption of uncooked or undercooked meat.2,3,4 The course of infection has two phases, the prodromal phase and the icteric phase. The infection is self-limited. Whether protective immunoglobulins develop against future re-infection remains unknown. The overall case fatality rate is 4%, although pregnant women and liver transplant recipients may be at substantially higher risk.

HEV infection is usually diagnosed by detecting specific anti-HEV antibodies (IgM and IgG). Analysis of HEV RNA in biologic specimens such as stools, serum, and liver biopsy using NATs is also used for diagnosis.

Anti-HEV IgM appears during acute stage of the infection and is detectable four days after the onset of jaundice and persists for up to five months.5 However, strongly positive reactions are rare after three months.6 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. The anti-HEV IgM assays could be used as first line tools for the routine diagnosis of acute HEV infection, even in immunocompromised patients. 

The HEV IgM Rapid Test is a lateral flow immunoassay for the direct detection of anti-HEV IgM. It will provide a presumptive diagnosis of acute infection of hepatitis E.

Test Procedure

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