Roche announced that the FDA has approved its first HIV-1/HIV-2 qualitative test reagent.

On September 1st Roche announced that the FDA had approved its cobas® HIV-1/HIV-2 test reagents for fully automated cobas®6800/8800 systems.
the reagent provides healthcare professionals with accurate results to diagnose and identify and distinguish HIV-1 and HIV-2 infections, providing clinicians with critical diagnostic data for personalized management and targeted treatment.
that half of new HIV infections may be in the acute phase between 3 and 3 weeks after infection.
current serological-based testing methods depend on the ability to detect antibody or antigen responses.
, patients may not be able to identify infections if they are tested before they develop detectable antibodies or antigen responses that can take weeks to produce.
PCR technology used with cobas HIV-1/HIV-2 qualitative testing is more sensitive, reducing the detection "window period" by one week or more.
this significant reduction in testing time is critical to improving personalized care while curbing further spread of the disease.
cobas HIV-1/HIV-2 qualitative testing reagent is an in-body nucleic acid amplification reagent used to assist in the diagnosis of HIV-1/HIV-2 infection.
HIV-1 or HIV-2 nucleic acids detected in an individual's plasma or serum indicate HIV-1 or HIV-2 infection, HIV-1 or HIV-2 nucleic acids are detected, and HIV-1 or HIV-2 antibodies are not found to indicate acute or primary infection.
This qualitative test reagent can also be used to detect the presence of HIV-1 or HIV-2 infections in confirmed antigen or antibody-detecting reactive samples, and can also be used to assist in the diagnosis of HIV-1 and/or HIV-2 infections in pediatric subjects and pregnant women.
the U.S. Centers for Disease Control and Prevention (CDC) estimates that 1.2 million people in the U.S. were infected with HIV in 2018;
human immunodeficiency virus (HIV) is divided into HIV-1 and HIV-2 two types.
worldwide, the majority of people living with HIV are infected with HIV-1, and HIV-2 is mainly confined to people in or from West Africa.
, HIV-2 has recently increased steadily in the United States.
HIV-1 and HIV-2 have the same transmission pathways, both of which can cause accessible immunodeficiency syndrome (AIDS);
reference: s1. 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 s1. 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.