HIV-1 assay receives two CE marks, for viral load and early infant diagnosis

Hologic has announced that its Aptima HIV-1 Quant Dx assay has received two new CE marks in Europe – for early infant diagnosis (EID) and for testing dried blood spots (DBS). This means the assay can be used qualitatively to 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 (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 Aptima HIV-1 Quant Dx assay is an in vitro nucleic acid amplification test (NAAT) for the detection and quantitation of HIV type 1 (HIV-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. 


The Aptima HIV-1 Quant Dx assay is processed on Hologic’s Panther system, an integrated platform that fully automates molecular testing with true sample-to-result automation, adaptable workflow options, and a broad testing menu. The Panther system is designed to be modular and scalable, accommodating the needs of large, centralised laboratories as well as smaller, decentralised facilities. The Panther system offers the highest throughput per square metre of any comparable molecular diagnostic instrument – up to 320 results in eight hours in less than one square metre of space.