cobas® DPX

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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.

Features and benefits

Features of the cobas® DPX test
 
  • Detects B19V genotypes 1, 2, and 3, and HAV genotypes I, II and III
  • Broad linear dynamic range across 7 logs of concentration for B19V
  • 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—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

 

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.

 

US – Indication for use

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

Package inserts

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

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