cobas® TaqScreen DPX Test

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Real-time discrimination of B19V and HAV in one assay

Increasing the safety of human plasma and plasma products

 

The cobas® TaqScreen DPX Test a real-time polymerase chain reaction (PCR) assay that detects parvovirus B19 (B19V) and hepatitis A virus (HAV) in human plasma.

Features and benefits

  • Simultaneously quantifies B19V DNA and detects HAV RNA in real-time
  • Detects B19V genotypes 1, 2 and 3 and HAV genotypes I, II, III
  • Available as a B19V DNA-only quantitative assay or a dual/result B19V DNA titer and a HAV RNA reactive/non-reactive
  • Ready-to-use reagents that do not require freezing

Markedly reduce the risk of transfusion transmission

Designed to run on the cobas s 201 system, the cobas® TaqScreen DPX Test can help manage the B19V burden in plasma pools and identify HAV-contaminated units while increasing processing efficiency.

Intended use

Intended use

The cobas® TaqScreen DPX Test, for use on the cobas s 201 system, is an in vitro nucleic acid amplification 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.

The cobas® TaqScreen DPX 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 hepatitis A virus RNA in plasma intended for further manufacture. Plasma from whole blood (recovered plasma) or collected by apheresis (source plasma) may be used. Plasma from all donors or manufacturing pools may be tested as individual specimens or in pools comprised of aliquots of individual specimens.

This test is not intended for use on samples of cord blood.
This test is not intended for use as an aid in diagnosis.

The cobas® TaqScreen DPX Test, for use on the cobas s 201 system, is an in vitro nucleic acid amplification test for the direct quantitation of human parvovirus B19 (B19V) DNA (genotypes 1, 2, and 3) and the direct qualitative detection of hepatitis A virus (HAV) RNA (genotypes I, II, and III) in human plasma.

*This test is not an FDA-licensed product. It is available to US laboratories with appropriate FDA authorization.

Registration status

CE-IVD

Package inserts

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

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cobas s 201 system

Discover efficiency, reliability and modular automation in the first multi-dye, nucleic acid amplification technology for blood and plasma.

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