The Aptima HIV-1 Quant Dx Assay. Credit: Business Wire.

Hologic has received two new CE-Marks for its Aptima HIV-1 Quant Dx Assay in early infant diagnosis (EID) and to test dried blood spots (DBS) in Europe.

The assay is an in-vitro nucleic acid amplification test (NAAT) designed to detect and quantitate HIV type 1 (HIV-1) on the company’s Panther system.

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The Aptima HIV-1 Quant Dx Assay has been designed to aid in HIV-1 diagnosis, as a confirmation of the infection, and as an aid in the clinical management of infected patients.

“The assay is an in-vitro nucleic acid amplification test (NAAT) designed to detect and quantitate HIV type 1 (HIV-1) on the company’s Panther system.”

Furthermore, the test can be used along with clinical presentation and other laboratory markers for disease prognosis.

It is said to be the first dual-claim assay for early infant diagnosis as well as viral load.

The clearance allows the use of the assay for qualitative identification of HIV-1 RNA as an aid to diagnose HIV-1 infected infants aged less than 18 months.

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In addition, the assay can be used to analyse an additional sample type (DBS) for monitoring viral load and disease progression in European and African patients infected with HIV-1.

The DBS claim is critical in the African market because it is a more stable and easily transportable, compared to liquid blood, Hologic noted.

Hologic Europe South and 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.”

The Hologic Panther system is a fully automated molecular testing device. It is said to feature high throughput, delivering up to 320 results in eight hours.