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

  • The CE-IVD version is an in-process test which simultaneously quantifies B19V DNA and detects HAV RNA
  • The test has a limit of detection of 11.5 IU/mL and a linear range from 75–3E8 IU/mL for B19V DNA
  • The test has a limit of detection of 1.1 IU/mL for HAV RNA
  • This test is not an FDA-licensed product. It is available to US laboratories with appropriate FDA authorization

Features and Benefits

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

Intended Use

(CE-IVD, Rev. 1.0)
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.

(US – Indication of 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 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.