Hepatitis E Virus
Overview
Clinical

Epidemiology

Hepatitis E is an inflammation of the livercaused by infection with the Hepatitis E Virus(HEV).
The virus is transmitted via the fecal-oralroute, principally via contaminated water.

Every year there are an estimated 20 million HEV
infections worldwide, leading to an estimated 3.3
million symptomatic cases of Hepatitis E.
WHOestimates
thathepatitisE
causedapproximately 44 000 deaths in 2015 (accountingfor 3.3% of the mortality due to viral hepatitis)1.

HEV IgG CLIA RUO prototype
Assay SchemeQuantitative detection of antibodies (IgG) to Hepatitis E Virus in human serum
Assay scheme
Indirect Two-step assay (quantitative)

PMPs

SampleConjugate

Magnetic Beads coatedwith Werfen’s
recombinant HEV Ag

Serum/Plasma
with anti-HEV IgGs

mAb a-hu-IgG-isoluminol

Dose-response in HEV IgG RUO prototype
Calibrator
Sample

U/mL*

RLU’s

S0
S1
S2
S3
S4
S50
0.26
0.42
0.83
6.57
11.77

485
25,11039,08077,160401,288
577,319*Concentration of the calibrator samples obtained with areference method
Figure 1. Calibration curve for an indirect HEV IgG CLIA RUOAssay Range
S5/S0
1,190
prototype. Recombinant HEV Ag was used for coating PMPs on CLIA
RUO assay and aIgG labeled with Iso-luminol was used as a detector. A Table 1. Numerical results dose-response calibration curve.
pool of POS samples diluted in NEG serum at different concentrations
Signal-to-noise and assay range performance evaluation.
was used as a calibrator sample set.
1 Hepatitis E. WHO Factsheet July 2023. Accessed September 2023 . https://www.who.int/news-room/fact-sheets/detail/hepatitis-e

Method Comparison of HEV IgG RUO prototype vs reference assay
HEV IgG CLIA RUOPrototype
Ref MethodPOSNEGTotal

REACT25025NR01515Total

251540Figure 2. Method comparison for performance evaluation –HEV IgG sample from patient Testing. Quantitative correlation ofHEV IgG concentration obtained in HEV IgG CLIA RUO prototype of40 native individual native serum samples compared to theconcentration determined with the reference method. referencemethod:• NR=non reactive for HEV IgG• REACT= reactive for HEV IgG
For Werfen HEV IgG RUO CLIA prototype:• NEG = negative for HEV IgG• POS = Positive for HEV IgG

Cross-reactivity with HEV IgG RUO prototype
Sample ID
Cross-reactant
disease type

HEV IgG Reference CLIA

HEV IgG CLIA RUO Prototype

Samplenº

IU/mL

StatusCalculated concentration(U/mL)

StatusSample 1<<0.100

NR

0.00

NEG

Sample 2<<0.100

NR

0.01

NEG

Sample 1<<0.100

NR

0.01

NEG

Sample 2<<0.100

NR

0.00

NEG

Sample 1<<0.100

NR

0.01

NEG

Sample 2<<0.100NR0.04

NEG

Sample 1<<0.100

NR

0.01

NEG

Sample 2<<0.100

NR

0.01

NEG

Sample 1<<0.100

NR

0.01

NEG

Sample 2<<0.100

NR

0.01

NEG

Hepatitis C (HCV)

Sample 1<<0.100

NR

0.01

NEG

HEV IgM

Sample 1<<0.100

NR

0.02

NEG

Parvovirus B19

EBV VCA IgG

CMV IgG

Hepatitis B (aHBc)

Hepatitis B (HBsAg)

Table 2. Cross-reactant sample testing. Different samples from other infectious diseases were tested for cross-reactivity
towards HEV IgG Werfen RUO prototype assay. None of them show any cross-reactivity, accordingly to the results obtained withthe reference method.

Werfen’s Biomaterial offering
Recombinant HEV Ag (ref 3000-7065)
Storage: -70ºC
Source: Escherichia coli
Storage buffer: MES , NaCl pH 9.3
Purification method: Affinity chromatography
Protein concentration:1 mg/mL
Preservative: None
This product is in R&D Stage and is for “Investigation / Research Use Only”. The content within this brochure is provided for informational purposes.
Contact oem@werfen.com for further technical information and product availability
Version 2 Dec 2023