Hepatitis E

Hepatitis E, which was previously called enterically transmitted non-A non-B hepatitis, is caused by infection with hepatitis E virus (HEV), a RNA virus that is still not classified. The first experimental evidence for the existence of HEV was reported by Balayan, who observed viral particles in size of 27-38nm isolated from the stool of infected individuals. HEV is transmitted through the fecal-oral route, predominately through contaminated water or food supplies. Sporadic outbreaks of hepatitis E have been reported in China and in other developing countries.

Geographic areas where more than 25% of the non-A non-B non-C hepatitis incidents are caused by infection with HEV HEV RT-PCR positive detection in humans HEV RT-PCR positive detection in hogs Geographic areas with severe hepatitis E outbreaks

The disease progression of Hepatitis E is similar to infection with Hepatitis A. However, severe form of hepatitis is easier to develop, especially when the individual is super-infected with another hepatitis viruses. The overall mortality ranges from 0.5% - 4.0% and may reach a rate of 20% among pregnant women during the 3rd trimester of pregnancy.

Introduction to Wantai Hepatitis E Virus Diagnostic Kits

We have cloned and expressed recombinant HEV antigen which has been utilized in the development of HEV detection assays and a novel vaccine: Wantai HEV IgM ELISA is sensitive, specific and a very useful diagnostic reagent for early diagnosis of acute hepatitis E infections. The "capture" method of our test overcomes the low sensitivity of the traditional "indirect" assays. The kit precisely distinguishes current from past infection with the virus Wantai HEV IgG ELISA is suitable for epidemiological studies and as an aid to the clinical diagnosis of hepatitis E Wantai HEV total antibodies ELISA can detect Hepatitis E infection in all animals and can be used as the standard reference method for the comparison of results obtained from different researches and veterinary laboratories Wantai HEV Ag ELISA intended for detection of viral antigens

Extensive Research on Hepatitis E Virus Highly Immunoreactive HEV Antigen

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Hepatitis E Diagnostic Kits: Features and Characteristics HEV-IgM ELISA

Sensitivity and specificity Among study group of 16865 individuals, (including 7113 blood donors), the specificity of Wantai HEV-IgM is 98.8%. In testing of acute hepatitis A, B and C sera, the overall specificity is 95.3%.
98.8% 96.7% 85.4%

Sensitivity and specificity Samples from 50 cases diagnosed positive during the Xinjiang hepatitis E outbreak in 1986 (> 10 years postinfection), were tested with Wantai HEV-IgG ELISA. The detection rate of the test within this study group is 86%.
Reagent Wantai HEV-IgG HEV ELISA 1 HEV ELISA 2 Samples 50 50 50 Pos. 43 18 15 Sens. 86.0% 36.0% 30.0% Positive sera OD MIN 0.532 0.514 0.229 AVER. 1.368 1.018 0.457 MAX 2.327 2.415 1.094
Positive sera average S/CO

HEV-IgG ELISA

9.24 1.98 2.08

Comparison study between Wantai HEV-IgM ELISA and two other commercial tests for detection of HEV.
Reagents Acute Hepatitis E Healthy individuals Overall positive/ negative/ agreement sensitivity specificity tested tested 47/48 35/48 45/48 97.9% 72.9% 93.8% 273/273 264/273 233/273 100% 96.7% 85.3% 97.9% 69.6% 79.1%

Multi-centre sensitivity evaluation study with Wantai HEVIgG ELISA. Demonstrated overall detection rate of >99%.
Testing Centre Wantai HEV-IgG positive 96 120 216 positive rate 97.96% 100.0% 99.08% Reference HEV-IgG positive 90 112 202 positive rate 91.84% 93.33% 92.66% No. tested 98 120 218

Wantai HEV-IgM HEV ELISA 1 HEV ELISA 2

Centre 1 Centre 2 Total

HEV Total Ab ELISA for Animals

Worldwide animal infection establishes HEV in the place of zoonosis. The virus has been isolated from the liver of pigs, which have been sold in supermarkets. Therefore, the correct diagnosis is important for understanding of HEV and its zoonosis-related issues.
Species Hogs Cattle Goats Chicken

Prevalence studies of anti-HEV among animals no. tested 8628 392 370 173 no. positive 7179 25 5 3 positive rate (%) 83.4 6.4 1.35 1.7

HEV VACCINE
Vaccine Characteristics
Recombinant Hepatitis E vaccine based on E. coli expression system Active component: recombinant HEV antigen (E2) which exists mainly as Virus-like Particles (VLPs) that can mimic major neutralized epitopes of the native HEV The ED50 is below 0.25 micrograms (mouse), and the protective efficacy is 83% and 100% against developing of symptom and infection of Hepatitis E respectively in rhesus monkey model

Vaccine Applications
Vaccination of individuals in endemic areas Vaccination of travelers Vaccination of military personnel General population vaccination

The Only Hepatitis E Vaccine in the World that has Entered into Phase-III Clinical Trial
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