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cobas® DPX

Duplex test for parvovirus B19 and HAV

The cobas® DPX test, for use on the cobas® 6800 and 8800 Systems, is a multi-dye, duplex real-time PCR test for parvovirus B19 (B19V) and HAV. Precise quantitation of B19V DNA and high sensitivity for HAV RNA meet current regulatory requirements for plasma intended for further manufacture.

Features and Benefits

  • Provides complete genotype coverage for B19V (1, 2, 3A, 3B) and HAV (IA, IB, IIA, IIB, IIIA, IIIB)
  • 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 WHO traceable international standard to provide quantitative results for B19V
  • 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® DPX 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® 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.

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.

This test is not intended for use on samples of cord blood.

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

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cobas® 6800/8800 Systems are not available in all markets, including the U.S.