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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

 

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.

*DPX has been submitted to the FDA as a Master File and will not have a regulatory classification; it will not be cleared, licensed or approved by the FDA.

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