Complete daily serological testing

Hepatitis E virus (HEV) is one of the leading causes of acute viral hepatitis worldwide, with a steadily increasing incidence and a particularly significant clinical impact in pregnant women, immunocompromised individuals, and patients with underlying liver disease. Although HEV RNA detection is the reference method for diagnosis, serology remains the most widely used approach for initial screening. Anti-HEV IgM antibodies are indicative of acute infection, whereas Anti-HEV IgG antibodies are markers of past infection. IgG avidity testing helps distinguish recent infections (low avidity) from past infections (high avidity), improving the interpretation of serological results.

Product features

Chemiluminescent immunoassays (CLIA) to detect antibodies against hepatitis E virus and its avidity in human serum or plasma samples.

  • Complete solution as an aid in the diagnosis of hepatitis E: HEV IgM, HEV IgG and HEV IgG avidity.
  • Highly specific IgM immunocapture method.
  • Quantification of IgG antibodies concentration using international units per milliliter (IU/ml) in accordance with the WHO standard. (no aplica a Toxo)
  • First and only commercial avidity test as an aid in the diagnosis of acute hepatitis E infection.
  • Monotest format with ready-to-use reagents.
  • Simple and automated protocol, with fast results.
  • Customizable configuration of samples and reagents according to laboratory needs.
  • Each monotest includes a calibrator and a negative control, enabling individual validation and interpretation of each sample.
  • Use of primary tubes, with no need for manual pipetting.
virclia monotest

Main recomendations for screening

  • In patients with acute hepatitis or acute liver failure.
  • In patients with known or newly diagnosed chronic liver disease who present with decompensation or signs of acute hepatic inflammation.
  • In patients with chronic hepatitis of unknown cause or liver disease of uncertain origin, especially in cases of immunosuppression.
  • In the transplant setting, particularly in organ donors and immunocompromised recipients, where HEV infection may become chronic.

EASL Clinical Practice Guidelines on Hepatitis E Virus Infection. Journal of Hepatology. 2018;68:1256–1271.

WHO. Hepatitis E – Fact sheet. World Health Organization.

ECDC. Hepatitis E – Annual Epidemiological Report. European Centre for Disease Prevention and Control.

PRODUCTS

HEPATITIS E VIRCLIA® IgG MONOTEST

CE0123 IVDR
Indirect chemiluminescent immunoassay (CLIA) to test IgG antibodies against hepatitis E virus in human serum/plasma.

Analytes: Hepatitis E virus

Reference VCM066
Contenido 24 test

HEPATITIS E VIRCLIA® IgM MONOTEST

CE0123 IVDR
Capture chemiluminescent immunoassay (CLIA) to test IgM antibodies against hepatitis E virus in human serum/plasma.

Analytes: Hepatitis E virus

Reference VCM067
Contenido 24 test

HEPATITIS E VIRCLIA® IgG AVIDITY MONOTEST

CE0123 IVDR
Indirect chemiluminescent immunoassay (CLIA) to test avidity of IgG antibodies against hepatitis E virus in human serum/plasma.

Analytes: Hepatitis E virus

Reference VCM093
Contenido 12 test

USED ON

VIRCLIA® LOTUS

virclia_lotus.jpeg

A compact automated CLIA platform for VirClia® infectious disease testing, combining ready-to-use single-test flexibility with continuous random access efficiency.

MORE RESOURCES

Virus/Bacterias
RELATED VIRUSES/BACTERIA

Related germs and organisms categorized for this product line.

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Bibliography
BIBLIOGRAPHY

Scientific bibliography and references related to this product.

Becquart A, Guigon A, Regueme A, Coulon P, Bocket L, Hober D, et al. Comparison of two automated commercial assays for routine detection of anti-hepatitis E Virus IgM antibodies in clinical samples. Vol. 109, Diagnostic Microbiology and Infectious Disease
Dichtl K, Zimmermann J, Koeppel MB, Böhm S, Osterman A. Evaluation of a novel clia monotest assay for the detection of anti-hepatitis e virus-igg and igm: A retrospective comparison with a line blot and an elisa. Pathogens. 2021 Jun 1;10(6).