cobas® HEV

Hepatitis E testing for donor screening

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

Broad HEV coverage, ready-to-use

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.

Features and benefits
  • Provides broad coverage of all 4 major HEV genotypes
  • Ready-to-use reagents—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.

Intended use

Intended use

The cobas® HEV test for use on cobas® 6800 and cobas® 8800 Systems is a qualitative in vitro nucleic acid amplification test for the direct detection of hepatitis E virus (HEV) RNA (genotypes 1-4) in human plasma.

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 (red cells, platelets, and plasma), and other living donors. Plasma from all donors may be screened as individual samples. For donations of whole blood and blood components, plasma samples may be tested individually or plasma may be tested in pools comprised of aliquots of individual samples.

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.

Registration status

CE-IVD