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Hologic Aptima HIV-1 Assay Receives Dual Claim CE Marking

NEW YORK (GenomeWeb) – Hologic said today that it has received two CE marks for its Aptima HIV-1 Quant Dx Assay for use in testing dried blood spots and the early diagnosis of the disease in infants.

Hologic said that as a result of receiving the CE marks, the assay can be used in European and African countries to qualitatively detect HIV type 1 (HIV-1) RNA in infants that are less than 18 months old. Clinicians in those countries can also use the assay in testing dried blood spots to monitor viral load and disease progression in HIV-1 infected patients.

The firm said that the Aptima HIV-1 Quant Dx is the first dual-claim assay used for both viral-load testing and early diagnosis in infants. The claim involving use of dried blood spots — a more stable and easily transportable sample type than liquid blood — is particularly important in the African market, Hologic said.

João Malagueira, Hologic's vice president of Europe South and Indirect Markets, said in a statement that with 25 million people infected with HIV just in sub-Saharan Africa, the need for accessible testing remains urgent in order to manage care and reduce infection.

Hologic noted that the World Health Organization awarded prequalification for the use of its Aptima HIV-1 Quant Dx assay as an in vitro diagnostic using plasma samples in December 2017, which allows global health organizations to consider the assay for public sector procurement in resource-limited settings.

The assay is an in vitro nucleic acid amplification test that runs on Hologic's fully automated Panther system, which provides up to 320 results in 8 hours.