CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
March 2018—Hologic announced that its CE-marked Aptima HIV-1 Quant Dx assay has been awarded World Health Organization prequalification for in vitro diagnostics.
The Aptima HIV-1 Quant Dx assay is the first HIV-1 viral load assay with a dual claim for diagnosis and treatment monitoring, the company says. It uses the company’s proprietary real-time transcription-mediated amplification technology and runs on Hologic’s Panther system.
The WHO prequalification means the assay meets WHO standards of quality, safety, performance, and reliability and allows worldwide health organizations to consider the assay for public sector procurement in resource-limited countries.
Hologic, 508-263-2900