INTRODUCTION

Strip immunoassay with recombinant antigens for the detection of IgG or 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 in developing countries world-wide, usually resulting from contaminated drinking water. In recent years reports of sporadic HEV infections in industrialised countries without travel-association have been more frequent, often with a subclinical or asymptomatic course. Almost all of these so-called autochthonous cases of hepatitis E are associated with genotype 3 of HEV which shows a high sequence-homology to genotype 3 isolates from pigs. The possibility of a zoonotic infection from pigs or other animals to humans seems to play a role as well as the transmission from person-to-person through contaminated foods or blood products.

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. In endemic regions in a high percentage of cases HEV infections during pregnancy follow a fulminant course, accompanied by a high mortality rate of approx. 20%. In males and non-pregnant females the mortality rate is 0.5% - 4.0%.

The recomLine HEV IgG/IgM uses purified recombinant antigens, thus guaranteeing reproducibly high sensitivity and specificity. The selection of homologous proteins from two different genotypes (genotype 1 and genotype 3) provides a high sensitivity also in non-endemic areas with a high percentage of autochthonous cases of hepatitis E.

PRODUCT ADVANTAGES

• Recombinant antigens
  • High sensitivity and specifity
  • Easy and clear interpretation due to easy to read bands
  • Homologous antigens of two different genotypes: genotype 1 and genotype 3
  • Detection of all four HEV-genotypes
• Easy test procedure; automation possible
• Easy and objective evaluation and documentation by recomScan software
• Test procedure and reagents identical in all MIKROGEN strip tests -  reagents exchangeable
• Separate detection of IgG- and IgM-antibodies – conjugate control on each strip
• Safe evaluation due to strip specific cutoff control
• CE label: The recomLine HEV test meet the high standard of EC directive 98/79/EC on in vitro diagnostic medical devices
• Application for confirmation as well as for screening

TESTPRINCIPLE AND PROCEDURE

1^st Incubation
A test strip loaded with HEV antigens is incubated with diluted serum or plasma in a dish for 1 hour.

wash 3 times

2^nd Incubation
Peroxidase conjugated anti-human antibodies (IgG or IgM specific) are added. Incubate for 45 minutes.

wash 3 times

Color reaction
8 ± 2 minutes after addition of the coloring solution, insoluble colored bands develop at the sites on the test strips occupied by antibodies.

RECOMBINANT HEV ANTIGENS

*ORF = open reading frame

EVALUATION

Sensitivity

¹Charité, University Hospital, Berlin, Germany
²IINSTAND e.V., Düsseldorf, Germany,  no evaluation of IgM

Specificity

³Positive for (and/ or in each case) HBs-, HBe-antigen, HBs-IgM-, anti-HBs-, anti-HBc-, anti-HCV, HAV-IgM-, HAV-IgG-antibodies (Charité, University Hospital, Berlin, Gemany)
⁴In 2 comparative assays (ELISA) negative samples of blood donors (BRK, Bavarian Red Cross, Germany).

STORAGE AND SHELF LIVE

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

COMMERCIAL PRODUCT