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cobas® WNV

Highly sensitive detection of West Nile Virus in human plasma

Image of cobas® WNV assay for the detection of West Nile Virus in donated blood

Detect West Nile Virus RNA in human plasma for an extra level of safety all-year long

The cobas® WNV Test is a Nucleic Acid Test (NAT) using real-time polymerase chain reaction (PCR) technology to detect West Nile virus (WNV) for use on the cobas® 6800/8800 Systems.

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Ensure global WNV coverage to reduce the risk of transfusion transmission

Bringing high sensitivity for both WNV lineages, cobas® WNV ensures all regions are covered globally. The test also provides broad coverage of additional flaviviruses that are mosquito-borne: JEV, SLEV, MVEV, and KUNV, (now known to be a subtype of WNV), that can cause transfusion-transmitted infections. Detecting flaviviruses that other market tests cannot provides additional protection against potential threats to the blood supply.

Lab technician organizing blood samples.

Screen donated blood with the world’s leading nucleic acid amplification technology

Test a variety of genetic material

 

  • Detection of both WNV lineages 1 and 2
  • Broad screening utility: whole blood, blood components, and cadaveric* (non-heart beating) organs and tissues
    *CE-IVD only, please review Instructions for Use for full details

 

Results in real-time for testing you can trust

 

  • 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
  • cobas® WNV Control Kit provides true external positive controls that have no effect on result calculation
  • Can be run simultaneously with other assays on the cobas® 6800/8800 Systems

Markedly reduce the risk of transfusion transmission

Designed to run on the cobas® 6800/8800 Systems, the cobas® WNV Test allows donor screening laboratories to maximize blood safety, with full process internal and external positive controls, while reducing hands-on time with full automation at every step.

Lab technician experiencing the true walk away automation offered by 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.

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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.

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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.

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Intended use

Intended use

The cobas® WNV test is a qualitative in vitro test for the direct detection of West Nile Virus (WNV) RNA in human plasma.

This test is intended for use to screen donor samples for WNV RNA in plasma samples from individual human donors, including donors of whole blood and blood components, as well as other living donors. This test is also intended for use to screen organ and tissue donors when donor samples are obtained while the donor’s heart is still beating and in testing of cadaveric (non-heart beating) donors.
This test is not intended for use on samples of cord blood.

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 may be tested in pools comprised of aliquots of individual samples. For donations from cadaveric (non-heart beating) organ and tissue donors, samples may only be screened as individual sample. This test is not intended for use as an aid in diagnosis of WNV infection.

cobas® WNV for use on cobas® 6800 and cobas® 8800 Systems is a qualitative in vitro nucleic acid screening test for the direct detection of West Nile virus (WNV) RNA in human plasma.

This test is intended for use to screen donor samples for WNV RNA in plasma samples from individual human donors, including donors of whole blood and blood components, as well as other living donors. This test is also intended for use to screen organ and tissue donors when donor samples are obtained while the donor’s heart is still beating.

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 in pools comprised of not more than six individual samples.

This test is not intended for use as an aid in diagnosis of WNV infection.
This test is not intended for use on samples of cord blood.
This test is not intended for use on cadaveric blood specimens.

Registration status

CE-IVD, US-IVD

Package inserts

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

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