cobas® HEV

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Broad HEV coverage, ready-to-use

Detects emerging zoonotic pathogen

 

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 (CE-IVD)

 

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.

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