FDA approves Roche’s HIV-1/HIV-2 test for use in cobas Systems

2 September 2020 (Last Updated September 2nd, 2020 11:48)

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.

FDA approves Roche’s HIV-1/HIV-2 test for use in cobas Systems
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.”

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.