Roche's first HIV-1/HIV-2 qualitative test reagent was approved by the FDA.

Roche announces that the FDA has approved its cobas? HIV-1/HIV-2 qualitative test reagents for fully automatic cobas? 6800/8800 system.
the reagent will provide healthcare professionals with accurate results to diagnose and identify hiv-1 and HIV-2 infections, providing clinicians with critical diagnostic data for personalized management and targeted treatment.
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.
2018, 1.2 million people in the United States were infected with HIV.
, more than 160,000 people are unaware of their HIV status.
, the number of people infected with HIV-2 has steadily increased in the United States.
that HIV-1 and HIV-2 have the same transmission pathways, both of which can cause accessible immunodeficiency syndrome (AIDS).
but the two are not treated in the same way, which means it is important to distinguish between HIV-2 infection and HIV-1 infection, so that doctors can treat the disease.
studies have shown that half of new HIV infections may be acute three days to three weeks after infection, but serological-based testing still relies on the ability to detect antibodies or antigen responses.
means that patients may not be able to identify infections if they are tested before they have detectable antibodies or antigen responses that can take weeks to produce.
the cobas HIV-1/HIV-2 qualitative test, when used with PCR technology, will be more sensitive and can quickly identify infections, allowing treatment based on the type of HIV infection.
noted that cobas HIV-1/HIV-2 qualitative testing reagents can shorten the "window period" of the test by a week or more.
, 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.
when HIV-1 or HIV-2 nucleic acids are detected in an individual's plasma or serum, HIV-1 or HIV-2 infections are detected, respectively, and acute or primary infections are prompted when HIV-1 or HIV-2 nucleic acids are detected and NO HIV-1 or HIV-2 antibodies are found.
Currently, the qualitative test reagent can also be used to detect HIV-1 or HIV-2 infections in samples that confirm antigen or antibody detection, in addition to assisting in the diagnosis of HIV-1, HIV-2 infections in pediatric subjects and pregnant women.
2014, Roche Diagnostics also introduced cobas HIV-1 test kits for cobas 6800/8800 systems in all markets that recognize CE marking, with a dynamic range of 20 to 10 to 7cp/ml, which is currently the lowest of all HIV load tests listed in China, effectively preventing leakage and misdiagnosis.
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