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cobas® WNV

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Directly detect West Nile Virus RNA in human plasma early in the infection lifecycle.

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

Features and benefits

Features of the cobas® WNV Test

  • Detection of both WNV lineages 1 and 2
     

Results in real-time for testing you can trust

  • 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
  • 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
Intended use

Intended use

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 beatingusing plasma or from cadaveric (non-heart beating) donorsusing plasma and serum.

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. For all other donors, samples may only be screened as individual samples.

For donations from cadaveric (non-heart-beating) organ and tissue donors, samples may only be screened as 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.

 

Registration status

US-IVD