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cobas^® TaqScreen DPX Test

Duplex test for parvovirus B19 and HAV

Real-time discrimination of B19V and HAV in one assay

The cobas® TaqScreen DPX Test incorporates multiple dyes, which allows for the simultaneous detection of donor blood infected with the parvovirus B19 (B19V) and the hepatitis A virus (HAV) in one test. The use of real-time polymerase chain reaction (PCR) technology enables the direct quantitation of B19V and the direct qualitative detection of HAV, which aids in the identification of infected plasma specimens and in keeping the blood supply safe.

Lab technician performing working on a Roche system

Rapidly detect HAV and parvovirus b19 with one antigen test kit

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 titre and a HAV RNA reactive/non-reactive
Ready-to-use reagents that do not require freezing

Reduce the risk of transfusion transmission, even for asymptomatic infections

Relying on donor medical history to screen for the presence of “slapped cheek” (B19V) and HAV infections can be problematic as the infections are often asymptomatic. The cobas® TaqScreen DPX Test, designed to run on the cobas s 201 system, can help manage the B19V burden in plasma pools and identify HAV-contaminated units while increasing processing efficiency. The cobas® TaqScreen DPX Test, incorporates multiple dyes, which allows for the simultaneous detection of donor blood infected with the parvovirus B19 and the HAV in one test procedure.

Intended use

CE-IVD

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–IVD

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.