Roche launches HIV-1 test in EU

Roche, a Basel, Switzerland-based research-focused healthcare company, announced on Tuesday that the new version of its dual-target HIV-1 qualitative test is now able to be sold for clinical use in the European Union.

The COBAS AmpliPrep/COBAS TaqMan HIV-1 Qualitative Test version 2.0 received CE mark certifications which also allows it to be sold for clinical use in non-EU countries that accept CE marked products. The test works by amplifying and detecting two separate regions of the HIV-1 genome which are not subject to selective drug pressure. Roche said the dual-target design allows for more reliable results in diagnosing HIV-1 infection.

The test works with both plasma and dried blood spot collection cards. DBS cards eliminate the need for refrigeration and significantly reduce the volume of blood to be stored or transported.

Roche said the test makes sample collection and transportation easy, even from the smallest infant in the most remote area.

"The ability to determine the HIV status of an infant as early as six weeks is crucial to determining the appropriate care and support for HIV-positive babies," Paul Brown, the president of Roche Molecular Diagnostics, said. "With this new solution from Roche we are reiterating our commitment to healthcare solutions that make a real difference for patients."

Early diagnosis is critical for children with HIV. If found HIV positive, they can receive necessary medical care before they develop significant illness.