cobas® HEV

Broad HEV coverage, ready-to-use

Image of cobas® HEV assay for the detection of HEV in donated blood

Detects emerging zoonotic pathogen in donor blood

The cobas® HEV Test is a real-time PCR test for hepatitis E virus (HEV), for use on the cobas® 6800/8800 Systems.

Safeguard blood and plasma products against hepatitis E

HEV is an important cause of acute hepatitis in humans worldwide, both as epidemic and sporadic disease, and many ongoing studies are trying to understand the prevalence of HEV in blood donors.

Preventing transfusion-transmitted infections, like HEV and other emerging pathogens, is a key focus for Roche in their work to keep the blood supply safe.

Woman having her blood drawn

Reliable infectious disease detection with broad genotype coverage

  • cobas® HEV test provides broad coverage of all 4 major HEV genotypes
  • Ready-to-use reagents with no thawing, pouring or mixing required
  • Stabilized real-time PCR reagents do not require calibration
  • Full-process internal control helps ensure result integrity
  • True external positive controls that have no effect on result calculation with cobas® HEV Control Kit

Markedly reduce the risk of transfusion transmission

cobas® HEV was designed to run on the cobas® 6800 and 8800 Systems, simultaneously with other assays if desired. It can help manage the hepatitis E virus in plasma pools and identify HEV-contaminated units while increasing processing efficiency. Parallel processing enables the cobas® 6800 System and cobas® 8800 System to perform up to any 3 tests in the same run with no pre-sorting required, while a dedicated priority lane enables fast and easy handling of high-priority.

Lab technician walking in past a cobas® 6800 system
lab technicians looking at blood screening results from a cobas® 6800 system

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lab technician automating workflows with cobas® 8800 system

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Intended use

Intended use

The cobas® HEV Test is a qualitative in vitro nucleic acid amplification test for the direct detection of Hepatitis E Virus (HEV) genotypes 1-4 RNA in human plasma. The cobas® HEV Test is intended for use as a blood screening or plasma test to detect HEV RNA.

 

This test is intended for use to screen donor samples for HEV RNA in plasma samples from individual human donors, including donors of whole blood, blood components, and other living donors, or to test plasma samples to detect HEV RNA. Plasma from whole blood (recovered plasma), blood components, or collected by apheresis may be used. Plasma from all donors or manufacturing pools may be tested as individual samples or in pools comprised of aliquots of individual specimens.

 

This test is not intended for use on samples of cord blood.

This test is not intended for use as an aid in diagnosis for HEV.

 

cobas® 6800/8800 Systems are not available in all markets.

Registration status

CE-IVD

Package inserts

Access package inserts through your country’s Roche Diagnostics Website.