FDA Pre-Market Approval for the BioPlex 2200 HIV Ag-Ab Assay
The BioPlex 2200 HIV Ag-Ab assay from Bio-Rad Laboratories offers early detection of HIV by detecting HIV antigens (proteins that are part of the HIV virus) and HIV antibodies (proteins that are produced by the body to fight the HIV infection).
In addition to the early detection offered by other tests, the 5th generation BioPlex HIV Ag-Ab assay provides more information by specifically identifying which individual HIV-1 or HIV-2 marker is positive. This additional information indicates if the patient was recently infected. Early treatment of these patients and outreach to those they may have infected reduces the risk of further transmission.
With the FDA pre-market approval, the BioPlex 2200 HIV Ag-Ab assay is approved for organ donor screening and helps in the diagnosis of infection in pediatric subjects as young as two years old and pregnant women
Date Published: August 17, 2015
Source article link: Bio-Rad Laboratories
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