FDA Approves Combination HIV-1/HIV-2 Test

The US Food and Drug Administration (FDA) has approved a Roche polymerase chain reaction diagnostic (PCR) which allows both qualitative detection and differentiation for HIV diagnosis.

The HIV-1/HIV-2 Qualitative will be available for use on the existing cobas 6800/8800 Systems.

It is an in vitro nucleic acid amplification test 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.

"The test provides healthcare professionals with a single result to confirm HIV diagnosis and differentiate HIV-1 and HIV-2, an important distinction needed to identify appropriate treatment options," a Roche statement reads.

50% of new HIV infections may be transmitted during what is known as the "acute period," 3 days to 3 weeks from the time of infection, according to data cited in the Roche statement.

This makes rapid diagnosis and connection to correct care essential in the fight against HIV/AIDS.

Regulators may have been motivated to go forward with approval by the fact that predominant serology-based testing methods rely on the ability to detect an antibody or antigen response. As a result, they can fail to identify an infection early on.

If a person is tested prior to having a detectable antibody or antigen response, a false sense of security and thus further HIV transmission is possible.

Roche argues that the sensitivity of PCR technology, which is used with the cobas HIV-1/HIV-2 Qualitative Test, can reduce this time-to-detection period by a week or more.

“Roche is committed to improving diagnostic technologies in the fight against HIV/AIDS,” said Thomas Schinecker, the firm's CEO. “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.”