Donor Screening Assays

Donor screening1

 

Keeping the Blood Supply Safe

Roche provides state-of-the-art PCR- and real-time PCR-based nucleic acid tests that enable labs worldwide to screen blood and blood products.

Roche systems are designed to improve workflow efficiencies, providing modular and automated solutions for labs of all sizes.

For use on the cobas® 6800/8800 System

  • cobas® MPX
  • cobas® WNV
  • cobas® DPX

cobas® MPX

One test, three results

Detects and discriminates the most critical viral targets in one easy-to-use assay

The cobas® MPX test, for use on the cobas® 6800/8800 Systems, is a multi-dye, real-time PCR multiplex test for HIV, HCV and HBV.

Features and Benefits

  • Real-time detection and identification of HIV, HCV and HBV eliminates both the need for discriminatory testing and the potential for discrepant results
  • Covers five critical viral targets: HIV-1 Group M, HIV-1 Group O, HIV-2, HCV and HBV in a single test
  • Dual-target approach, with amplification of separate regions of HIV-1, and dual probes for HCV, improves coverage of new virus variants
  • Broad screening utility, including donations of whole blood, blood components
  • Highly sensitive HBV detection of occult and low titer HBV infection
  • 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® MPX 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

The cobas® MPX test is a qualitative in vitro test for the direct detection of Human Immunodeficiency Virus Type 1 (HIV1) Group M RNA, HIV-1 Group O RNA, Human Immunodeficiency Virus Type 2 (HIV-2) RNA, Hepatitis C Virus (HCV) RNA, and Hepatitis B Virus (HBV) DNA in human plasma and serum.

cobas® WNV

Highly sensitive test with broad flavivirus coverage

Detects mosquito borne transfusion-transmitted infectious diseases (TTID) to provide extra level of safety.

The cobas® WNV test, for use on the cobas® 6800/8800 Systems, is a real-time PCR test for West Nile virus (WNV).

Features and Benefits

  • Highly sensitive for both WNV lineages 1 and 2
  • Provides broad coverage of other flaviviruses that cause transfusion-transmitted infectious diseases such as:
    • Japanese encephalitis virus (JEV)
    • St. Louis encephalitis virus (SLEV)
    • Murray Valley encephalitis virus (MVEV)
    • Kunjin virus (KUNV)
  • Broad screening utility, including donations of whole blood and blood components
  • 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

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

cobas® DPX

Duplex test for parvovirus B19 and HAV

Precise quantitation of B19V DNA and high sensitivity for HAV RNA

The cobas® DPX Test is a multi-dye, duplex real-time PCR test for parvovirus B19 (B19V) and HAV, for use on the cobas® 6800 and 8800 Systems.

The cobas® DPX Test is an in vitro test for the direct quantitation of parvovirus B19 genotypes 1, 2, and 3 DNA and the direct qualitative detection of Hepatitis A virus (HAV) genotypes I, II, and III RNA in human plasma.

cobas-dpx

Designed to run on the cobas® 6800 and 8800 Systems, the cobas® DPX Test can help manage the B19V burden in plasma pools and identify HAV-contaminated units.

This test is intended for use as an in-process test to quantify parvovirus B19 DNA alone or to simultaneously quantify parvovirus B19 DNA and detect HAV RNA in plasma intended for further manufacture collected from donors of whole blood, blood components, or plasma. Plasma from all donors or manufacturing pools may be tested as individual samples or in pools comprised of aliquots of individual samples.

Features and Benefits

  • Broad linear dynamic range across 7 logs of concentration for B19V
  • B19V titer limits can be adjusted by the user, based on pool size, to appropriately prompt pool deconstruction
  • The cobas® DPX test utilizes a standard that is traceable to the WHO international standard to provide quantitative results for B19V
  • Ready-to-use reagents only require refrigeration—there is no thawing, pouring or mixing of frozen reagents
  • Stabilized real-time PCR reagents do not require calibration
  • cobas® DPX Control Kit provides true external positive controls that have no effect on result calculation
  • Full-process internal control helps ensure result integrity
  • The test simultaneously quantifies B19V DNA and detects HAV RNA in a single test
  • Can be run simultaneously with other assays on the cobas® 6800 and 8800 Systems