Roche Announces FDA Approval of First cobas® HIV-1/HIV-2 Qualitative Nucleic Acid Test for cobas® 6800/8800 Systems

Source | Jike Yaowen

On September 1, Roche announced that the U.S. FDA has approved its cobas^®HIV-1/HIV-2 Qualitative Assay for the Fully Automated cobas System^®6800/8800 Systems. This reagent provides healthcare professionals with precise results for the diagnosis of HIV and for confirming and differentiating between HIV-1 and HIV-2 infections, delivering critical diagnostic data to clinicians to facilitate subsequent personalized management and targeted therapy.

Studies have shown that half of newly diagnosed HIV-infected individuals may be in the acute phase within 3 days to 3 weeks after infection. Current serology-based detection methods rely on the ability to detect antibody or antigen responses. Therefore, if patients are tested before a detectable antibody or antigen response (which may take several weeks to develop) appears, their infection may not be identified. The PCR technology used with the cobas HIV-1/HIV-2 qualitative test offers higher sensitivity, shortening the "window period" of this test by one week or more. This significant reduction in detection time is crucial for improving personalized healthcare while simultaneously curbing further disease transmission.

cobas HIV-1/HIV-2 Qualitative Assay is an in vitro nucleic acid amplification test used to aid in the diagnosis of HIV-1/HIV-2 infection. Detection of HIV-1 or HIV-2 nucleic acid in individual plasma or serum samples indicates HIV-1 or HIV-2 infection, respectively; detection of HIV-1 or HIV-2 nucleic acid in the absence of HIV-1 or HIV-2 antibodies suggests acute or primary infection. This qualitative assay can also be used to confirm the presence of HIV-1 or HIV-2 infection in samples that have shown reactive results in antigen or antibody tests, and it may further assist in diagnosing HIV-1 and/or HIV-2 infection in pediatric subjects and pregnant women.

The U.S. Centers for Disease Control and Prevention (CDC) estimates that 1.2 million people in the United States were living with HIV in 2018; among them, more than 160,000 were unaware of their HIV status. In the same year, there were 37,968 new HIV infections. Human immunodeficiency virus (HIV) is classified into two types: HIV-1 and HIV-2. Globally, the majority of individuals with HIV are infected with HIV-1, whereas HIV-2 is primarily confined to West Africa or populations originating from West Africa. However, HIV-2 cases have been steadily increasing in the United States in recent years. HIV-1 and HIV-2 share the same modes of transmission, and both can cause acquired immunodeficiency syndrome (AIDS); however, distinguishing between HIV-2 and HIV-1 infection is critical because they require different clinical management.

References:

[1] Roche receives FDA approval for first HIV-1/HIV-2 Qualitative Test on the cobas 6800/8800 Systems in the fight against HIV/AIDS. Retrieved 2020-09-01, from http://www.globenewswire.com/news-release/2020/09/01/2086558/0/en/Roche-receives-FDA-approval-for-first-HIV-1-HIV-2-Qualitative-Test-on-the-cobas-6800-8800-Systems-in-the-fight-against-HIV-AIDS.html

[1] Roche receives FDA approval for first HIV-1/HIV-2 Qualitative Test on the cobas 6800/8800 Systems in the fight against HIV/AIDS. Retrieved 2020-09-01, from http://www.globenewswire.com/news-release/2020/09/01/2086558/0/en/Roche-receives-FDA-approval-for-first-HIV-1-HIV-2-Qualitative-Test-on-the-cobas-6800-8800-Systems-in-the-fight-against-HIV-AIDS.html

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