Medical technology company Hologic has received two new CE marks in Europe for its Aptima HIV-1 Quant Dx assay for early infant diagnosis (EID) and for testing dried blood spots (DBS).
Image: Aptima HIV-1 Quant Dx Assay. Photo: Courtesy of Business Wire.
With the procurement of CE marks, the assay is qualified to use in qualitatively detecting HIV-1 RNA in the diagnosis of HIV-1 infected infants under 18 months old, and in testing an additional sample type (DBS) to monitor viral load and disease progression in HIV-1 infected individuals in European and African countries.
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, is designed to aid in the diagnosis of HIV-1 infection.
The assay is used as a confirmation of HIV-1 infection, and as an aid in the clinical management of patients infected with HIV-1, and can also be used in combination with clinical presentation and other laboratory markers for disease prognosis in HIV-1 infected individuals.
Hologic said that this is the first and only dual-claim assay for both viral load and early infant diagnosis. The dried blood spot claim is a much more stable and easily transportable sample type than liquid blood and is important particularly in the African market.
Hologic Europe south indirect markets vice president João Malagueira said: “With 25 million people infected with HIV in sub-Saharan Africa alone, there continues to be an urgent need for accessible testing, which is crucial for managing care and reducing the spread of this life-threatening infection.
These new product extensions, along with the recent announcement of our Hologic Global Access Initiative, underline Hologic’s commitment to providing accessible testing. They will enable healthcare providers in resource-limited settings to scale up their HIV testing programs to meet the 95-95-95 goals set out by the World Health Organization (WHO).”
On 21December 2017, T”the Aptima HIV-1 Quant Dx assay has received World Health Organization (WHO) prequalification for in vitro diagnostics using plasma samples.
This implies that the assay meets WHO standards of quality, safety, performance and reliability, and allows global health organizations to consider the Aptima HIV-1 Quant Dx assay for public sector procurement in resource-limited settings.
Hologic claims that tThe Aptima HIV-1 Quant Dx assay is processed on its Panther system, an integrated platform that fully automates molecular testing with true sample-to-result automation, adaptable workflow options, and a broad testing menu.
Furthermore, the Panther system offers the highest throughput per square meter of any comparable molecular diagnostic instrument – up to 320 results in 8 hours in less than one square meter of space.