cobas® DPX

Duplex test for parvovirus B19 and HAV

Image of cobas® DPX assay for the detection of parvovirus B19 and HAV in donated blood

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 hepatitis A virus (HAV), for use on the cobas® 6800 and 8800 Systems.

Features and benefits

Features of the cobas® DPX test 

 

  • Detects B19V genotypes 1, 2, and 3, and hepatitis A genotypes I, II and III
  • Broad linear dynamic range across 7 logs of concentration for parvovirus B19
  • B19V titer limits adjustable, based on pool size, to appropriately prompt pool deconstruction
  • Utilizes a WHO traceable international standard to provide quantitative results for B19V

 

Count on cobas for convenience and control

 

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

Intended use

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.

 

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.

The cobas® DPX for use on cobas® 6800 and cobas® 8800 Systems 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.

 

This test is not intended for use as an aid in diagnosis for parvovirus B19 or HAV infection.

Registration status

CE-IVD