INTRODUCTION

Enzyme immunoassay with antigens produced by recombinant techniques for the de­tec­­tion of IgG and IgM antibodies against hepatitis E Virus (HEV) in human serum or plasma

Hepatitis E virus (HEV) is one of the most common causes of faecal-orally acquired hepatitis world-wide. Infections usually result from contaminated drinking water. Concerning the distribution of the virus, a distinction is made between regions in which HEV is endemic and those in which infections occur sporadically. In recent years reports of sporadic HEV infections in non-endemic regions without travel-association have been more frequent. Besides the routes of transmission from person-to-person and through contaminated foods or blood products, a zoonotic infection from pigs or other animals to humans is under discussion. Investigations of the distribution of HEV in non-endemic regions suggest that HEV infections can sometimes follow an asymptomatic or subclinical course, especially in industrialised countries.

Acute hepatitis E is a severe illness with a comparable clinical presentation to hepatitis A. Typical signs of hepatitis E include flu-like symptoms, vomiting, diarrhoea, fever, arthralgia and headache usually associated with a rise in liver enzyme values. Cholestatic jaundice that develops during the course of disease can persist for several weeks. HEV infection is usually self-limiting and chronic persistent infections are unknown. HEV infections during pregnancy follow a fulminant course in a high percentage of cases, accompanied by a high mortality rate of approx. 20%. In males and non-pregnant females, the mortality rate is 0.5% - 4.0%.

The recomWell HEV IgG, IgM uses purified recombinant antigens, thus guaranteeing reproducibly high sensitivity and specificity. It is highly suitable as a screening test.

PRODUCT ADVANTAGES

• Recombinant antigens
• High sensitivity and specificity
• Excellent discrimination between negative and positive results
• Separate detection of IgG and IgM antibodies
• Identical procedure for IgG and IgM determination
• Test procedure and reagents identical in all MIKROGEN ELISA - reagents exchangeable
• Easy test procedure; automation possible
• Easy to quantify
• Break-a-part: single sample examination possible
• CE label: The recomWell HEV tests meet the high standard of the EC directive 98/79/EC on in vitro diagnostic medical devices

TESTPRINCIPLE AND PROCEDURE

Indirect sandwich test.
Recombinant antigens are bound to the solid phase.

1^st Incubation
Add patient samples diluted 1:101 (sample: 10 µl of serum or plasma), incubate for 1 h at 37 °C.

Wash 4 times

2^nd Incubation
Add peroxidase conjugated anti-human IgG or IgM antibodies (conjugate), incubate for 30 min at 37 °C.

Wash 4 times

Color reaction
Add ready-to-use TMB solution and incubate for 30 min at room temperature. Stop the substrate reaction with H₃PO₄ and measure the extinction at 450 nm.

EVALUATION

Sensitivity

¹Universitätsklinikum Charité, Berlin

²In-house-test, Max von Pettenkofer-Institut, Munich

Specificity
A diagnostic specificity can not be calculated at present, as no serological “gold standard“ is defined for HEV. Alternatively, the reactivity rate of hepatitis A-B-C positive sera was compared to the seroprevalence in blood donors.

³positive for (each and/or) HBs, HBe antigen, anti HBs IgM, anti HBs, anti HBc, anti HCV, anti HAV IgM, anti HAV IgG antibodies (Universitätsklinikum Charité, Berlin).

STORAGE AND SHELF LIVE

At +2°C - +8°C 12 months from the time of production

COMMERCIAL PRODUCT