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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.

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More complete coverage with a dual-target approach

Normally transmitted via the respiratory route, parvovirus B19 is known to also be transmitted via plasma products and red blood cell transfusion.1,2 Conversely, HAV is rarely a transfusion-related infection, but it can occur. Blood banks often do not test donations for the presence of HAV, and instead relying on donor medical history to eliminate donors with a history of hepatitis.3

 

The cobas® DPX Test addresses this potential gap, providing blood screening centers a reliable option for truly comprehensive donor screening.

Image of a lab technician loading a blood sample onto a tray

Reliable screening across the most common genotypes

 

·        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

 

Bringing convenience and control to donor screening

 

·        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

lab technicians looking at blood screening results from a cobas® 6800 system

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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

Package inserts

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

References:
  1. Blümel J, Burger R, Drosten C, et al. Parvovirus B19 - Revised. Transfus Med Hemother. 2010;37:339-350.
  2. Molenaar-deBacker MW, Lukashov VV, vanBinnendijk RS, Boot HJ, Zaaijer HL. Global co-existence of two evolutionary lineages of parvovirus B19 1a, different in genome-wide synonymous positions. PLoS One. 2012;7:e43206.
  3. Servant A, Laperche S, Lallemand F, et al. Genetic diversity within human erythroviruses: identification of three genotypes. J Virol. 2002;76:9124-9134.

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