Hologic Aptima HIV-1 Quant Dx Assay receives 2 CE Marks
Hologic announced that its Aptima HIV-1 Quant Dx Assay has received two new CE marks in Europe - for early infant diagnosis, or EID, and for testing dried blood spots, or DBS. This means the assay can be used to qualitatively detect HIV-1 RNA as an aid in the diagnosis of HIV-1 infected infants under 18 months old, and to test an additional sample type, or DBS, to monitor viral load and disease progression in HIV-1 infected individuals in European and African countries. It is the first and only dual-claim assay for both viral load and early infant diagnosis. The dried blood spot claim is particularly important in the African market as it is a much more stable and easily transportable sample type than liquid blood. The Aptima HIV-1 Quant Dx assay is an in vitro nucleic acid amplification test, or NAAT, for the detection and quantitation of HIV type 1 on the fully automated Panther system. It is intended as an aid in the diagnosis of HIV-1 infection, as a confirmation of HIV-1 infection, and as an aid in the clinical management of patients infected with HIV-1. The Aptima HIV-1 Quant Dx assay may also be used in conjunction with clinical presentation and other laboratory markers for disease prognosis in HIV-1 infected individuals.