Hologic assay awarded WHO prequalification

Sept. 15, 2020

Hologic announced that its CE-marked Aptima HIV-1 Quant Dx assay has been awarded World Health Organization (WHO) prequalification for testing of dried blood spot (DBS) samples, according to a company news release.

The WHO prequalification program facilitates access to tests and medications that meet unified standards of quality, safety and efficacy for HIV/AIDS, malaria and tuberculosis, according to the WHO.

Hologic’s Aptima HIV-1 Quant Dx assay can be used with DBS samples to monitor viral load and disease progression among HIV-1 infected individuals and to aid in the diagnosis of HIV-1 infected infants under 18 months.

DBS sampling improves access to HIV diagnostic testing and care, particularly among HIV-infected populations living in remote areas. DBS samples are more stable and easily transportable compared to liquid whole blood or plasma samples. A finger stick or heel prick produces an adequate sample that is dried on a specially designed card. The DBS samples do not require refrigeration and when stored properly can withstand extreme conditions, including excess heat and humidity.

Hologic said the WHO approval is notable for the African market, where DBS is the primary sample type in several countries, and is expected to enable countries to expand their use of the Aptima HIV-1 Quant Dx assay, the leading assay under Hologic’s Global Access Initiative (GAI). The GAI launched in 2018 and offers customers a single, all-inclusive pricing structure with no upfront cost or capital expenditure. Qualified products include molecular assays for HIV, Hepatitis B and C, and human papillomavirus (HPV), as well as the ThinPrep pap test for cervical cancer screening, Hologic said.

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