CE mark sanctions the use of the Cobas TaqMan HIV-1 Test in smaller labs.
Roche received a CE mark for the expanded use of its HIV monitoring test. This allows the Cobas® TaqMan® HIV-1 Test to be used in smaller laboratory settings. It utilizes the High Pure System Viral Nucleic Acid Kit for manual specimen preparation and the Cobas TaqMan 48 Analyzer for automated amplification and detection.
The diagnostic has a dual target approach that reportedly ensures enhanced reliability of test results and more confidence in assessing viral loads. Since Roche introduced this test in 2008, the company says that over 3.2 million tests have been performed for monitoring HIV patients on antiretroviral therapy.
The dual target strategy quantifies HIV-1 subtypes by avoiding the effects of rare mismatches in primer/probe binding sites of a target region. It simultaneously detects and amplifies two separate regions of the HIV-1 genome.