cobas HIV-1/HIV-2 Qualitative test is an in vitro nucleic acid amplification assay for the qualitative detection and differentiation of human immunodeficiency HIV-1 and HIV-2 RNA in human serum and plasma. Credit: Roche.

Roche has received US Food and Drug Administration (FDA) approval for its cobas HIV-1/HIV-2 Qualitative test for use on fully automated cobas 6800/8800 Systems in the US.

The test is an in vitro nucleic acid amplification assay for the qualitative detection and differentiation of human immunodeficiency virus type 1 (HIV-1) and type 2 (HIV-2) RNA in human serum and plasma.

It enables healthcare professionals to diagnose HIV with a single result. It also differentiates HIV-1 and HIV-2, offering appropriate treatment options for patients.

Roche Diagnostics CEO Thomas Schinecker said: “Roche is committed to improving diagnostic technologies in the fight against HIV/AIDS.

“Being able to reliably determine a person’s HIV status and accurately diagnose, which HIV type they may have, is crucial for patients and healthcare providers in preventing further community transmission and selecting an individual’s best treatment options.”

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Studies have found that 50% of new HIV infections are transmitted during the acute period, between three days and three weeks from the time of infection.

Roche’s test uses PCR technology, which reduces the time-to-detection period by one week or more.

Existing serology-based testing methods for HIV/AIDS depends on the ability to detect an antibody or antigen response. The tests often fail to identify an infection if the person is tested before having a detectable antibody or antigen response.

cobas HIV-1/HIV-2 Qualitative test can be used as an additional test to validate the presence of HIV-1 or HIV-2 infection in an individual with specimens reactive for HIV-1 or HIV-2 antibodies or antigens.

It may also be used as an aid in the diagnosis of infection with HIV-1 and / or HIV-2 in paediatric subjects and pregnant women, the company noted.