Search
User Profile
Change
Select your user profile

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.

CONTACT US

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

Donor Screening

Roche Blood Safety Solutions

Explore market-leading instruments, assays, IT solutions and automation developed to help screening centers achieve maximum safety and efficiency.

Explore

Donor Screening – Nucleic Acid Testing

Explore our commitment to developing assays, instruments and automation that deliver the highest level of safety and efficiency in donor screening.

Explore
Blood transfusion which will be screened by Roche solutions
lab technician automating workflows with cobas® 8800 system

Donor Screening - Personalized Lab Automation

Simplify operations, reduce manual tasks and increase both efficiency and quality with automation solutions for labs of all sizes.

Explore
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.

Related assays

Image of cobas® DPX assay for the detection of parvovirus B19 and HAV in donated blood
cobas® DPX
Image cobas® MPX assay for the detection of HIV, HCV, and HBV in donated blood
cobas® MPX
Image of cobas® WNV assay for the detection of West Nile Virus in donated blood
cobas® WNV
IVD For in vitro diagnostic use.
MagNA Pure 24 Instrument
MagNA Pure 24 Instrument A fully-automated clinical nucleic acid extraction system that brings you walkaway automation for up to 24 samples. The MagNA Pure 24 System is a fully automated clinical sample extractor. It extracts nucleic acids from various sample types, sample tubes, and volume inputs for multiple downstream applications.The main features of the system are:Scalable purification of 1 to 24 samplesPrimary/secondary tube handlingInventory and sample management via barcodesEfficient order management via host
IVD For in vitro diagnostic use.
MagNA Pure 96 Instrument
MagNA Pure 96 Instrument High-throughput robotic workstation for fully automated purification of nucleic acids from up to 96 samples. Magnetism is the underlying principle of the automated nucleic acid isolation performed by the highthroughput MagNA Pure 96 System. The MagNA Pure 96 Instrument performs automated nucleic acid purification from samples of up to 1000 μl that are pipetted into a 96-well processing cartridge. It comprisesa magnetic glass particles (MGP) based purification process as well as protocols that support isolation of RNA, DNA and tNA from different sample materials. The MagNA Pure 96 System permits automated nucleic acid purification that matches the high standards of speed, accuracy and reliability in PCR/ RT-PCR of the LightCycler® Systems.
IVD For in vitro diagnostic use.
cobas® 6800 System
cobas® 6800 System Embrace the future of molecular testing with proven PCR performance. Learn about the cobas® 6800 System’s broad menu of high-quality assays, including HIV, HPV, CT/NG, Hepatitis, CMV, WNV, respiratory infections, and more!
cobas® SARS-CoV-2
cobas® SARS-CoV-2
Product image for cobas® CT/NG
cobas® CT/NG
cobas® TV/MG box
cobas® ️TV/MG
SARS_Influenza_AB
cobas® SARS-CoV-2 &
Influenza A/B Assay
Product image for cobas® 4800 HPV Amplification/Detection Kit and cobas® HPV Qualitative nucleic acid test for use on the cobas® 6800/8800 Systems
cobas® HPV
Product image for cobas® CMV
cobas® CMV
Product image for COBAS® TaqMan® MTB Test
COBAS® TaqMan® MTB Test
Product image for cobas® HIV-1/HIV-2 Qualitative Test
cobas® HIV-1/HIV-2 Qualitative Test
Product image for cobas® HIV-1 Test
cobas® HIV-1 Test
Product image for cobas® HCV Test
cobas® HCV Test
cobas® HBV Test
cobas® HBV Test
cobas® TaqScreen MPX test, v2.0 rapid testing kit for HIV, HCV and HBV
cobas® TaqScreen MPX Test, v2.0
cobas CV DV
cobas® CHIKV/DENV
IVD For in vitro diagnostic use.
cobas® Liat® System
cobas® Liat® Analyzer Bring accurate and reliable PCR results to the POC, enabling answers patients and clinicians need in 20 minutes or less to support triage and patient management.
IVD For in vitro diagnostic use.
cobas® 5800 System
cobas® 5800 System The cobas® 5800 System makes automation, consolidation, integration and standardization more accessible than ever before.
IVD For in vitro diagnostic use.
LightCycler® PRO System
LightCycler® PRO System LightCycler® PRO integrates innovative technology and Roche manufacturing to deliver accurate real-time PCR results
IVD For in vitro diagnostic use.
digital lightcycler product thumbnail
Digital LightCycler® System Unleash the true power of digital PCR
IVD For in vitro diagnostic use.
cobas omni Utility Channel
cobas omni Utility Channel For use on the cobas® 5800/6800/8800 Systems Consolidate and automate IVD and LDTs on one platform with the cobas omni Utility Channel—maximise laboratory space, minimise capital investment, and decrease operational costs.
IVD For in vitro diagnostic use.
<b>cobas<sup>®</sup> eplex</b> system
cobas® eplex system The cobas eplex system integrates the entire process from order-to-report to better realize the patient and laboratory benefits of rapid, multiplex molecular diagnostics.
IVD For in vitro diagnostic use.
cobas® eplex blood culture identification Fungal Pathogen (BCID-FP) panel
cobas® eplex blood culture identification fungal pathogen (BCID-FP) panel The cobas® eplex blood culture identification (BCID) panels deliver the most comprehensive solution for testing patients suspected of bloodstream infections and sepsis, including patients with COVID-19.
IVD For in vitro diagnostic use.
cobas® eplex blood culture identification Fungal Pathogen panel
cobas® eplex blood culture identification gram-positive (BCID-GP) panel The cobas® eplex blood culture identification (BCID) panels deliver the most comprehensive solution for testing patients suspected of bloodstream infections and sepsis, including patients with COVID-19.
IVD For in vitro diagnostic use.
cobas® eplex blood culture identification Gram-Negative panel
cobas® eplex blood culture identification gram-negative (BCID-GN) panel The cobas® eplex blood culture identification (BCID) panels deliver the most comprehensive solution for testing patients suspected of bloodstream infections and sepsis, including patients with COVID-19.

Related systems

cobas® 6800 System

Transform your testing experience for IVD applications—just 2 simple user interactions per run and up to 8 hours of walk-away time.
More
cobas® 6800 System image

cobas® 8800 System

Unparalleled performance with minimal operator interaction revolutionizes the future of high-throughput applications. 

More
cobas® 8800 System image