Hologic, Inc. launches Aptima® HIV-1 Quant Dx assay in Zambia

HOLOGIC, Inc. has announced the launch of new HIV diagnosis tools in Zambia.

According to a press release yesterday, the Aptima® HIV-1 Quant Dx assay would provide new approaches to making it quicker and easier for laboratories to diagnose and monitor HIV infections in the country.

“The assay – the technical term for a laboratory test – has received two new CE marks. First, certification to use for early infant diagnosis to qualitatively detect HIV-1 RNA as an aid in diagnosing HIV-1 infected infants under 18 months. And second, testing of dried blood spots to monitor viral load and disease progression in HIV-1 infected individuals,” reads the statement. “The Aptima HIV-1 Quant Dx assay is the only test to have both these CE marks. In line with the 95-95-95 goals from UNAIDS, this high performance, accessible and flexible test will help governments and NGOs scale up the fight against a virus that continues to infect over 3,000 people daily in sub- Saharan Africa, with 1.7 million children and adolescents (0-19 years) already infected.”

According to the Hologic, Inc. statement, Zambia has an estimated 72,000 children under the age of 14 living with HIV and an estimated 7,300 children were newly infected with HIV in 2017.

“Early infant diagnosis is essential to improve prevention and treatment interventions, as peak mortality occurs between six weeks to four months of age for children who have acquired HIV infection,” reads the statement.

“The Aptima HIV-1 Quant Dx assay is a highly sensitive test which can use plasma, serum or dried blood spots to get an accurate HIV diagnosis on the fully automated PantherTM system. Thanks to its flexibility and accuracy, this integrated diagnosis solution will help overcome multiple challenges faced by local laboratories. The new DBS sample solution will improve the collection, preservation and transportation of samples from testing centres to laboratories.”

The Aptima HIV-1 Quant Dx assay, according to Hologic, Inc, was awarded World Health Organisation prequalification for in vitro diagnostics using plasma samples on December 21, 2017, which allows global health organisations to consider it for public sector procurement in resource-limited countries.

Following the recent Hologic Global Access Initiative, launched in partnership with the Clinton Health Alliance Initiative (CHAI) and MedAccess, the HIV-1 Quant Dx assay will be available at a price of $12, with no upfront cost or capital expenditure in nearly 50 nations including Kenya, Malawi, Tanzania, Uganda, Zambia and Zimbabwe, according to the statement.

“We designed the Aptima HIV-1 Quant Dx assay and the Panther system keeping in mind the specific needs of viral diagnosis laboratories in Africa, ” said João Malagueira, Hologic’s vice-president, Europe South and Indirect Markets.

“Through this integrated testing solution, we want to partner with local authorities and international organizations to help the fight against HIV in east and southern Africa. With 25 million people infected with HIV in sub-Saharan Africa alone, there continues to be an urgent need for accessible and reliable testing, which is crucial for managing care and reducing the spread of the infectious disease.”

According to Hologic, the PantherTM system is designed to be modular and scalable, accommodating needs of large labs and smaller ones in urban and rural areas, with minimum infrastructure requirements.

He indicated that PantherTM system offered the highest [coverage] per square metre of any comparable molecular diagnostic instrument – up to 320 results in 8 hours in less than 1m2 of space – which could make a big difference in smaller rural labs.

East and Southern Africa is home to the largest number of HIV-infected people in the world, with 19.6 million people living with the virus as at 2017.

According to Hologic, the region, however, has continued to make significant gains towards meeting the 95-95- 95 goals.

“Between 2010 and 2016, new HIV infections among children (aged 0-14) declined by 56 per cent, while new infections among adults declined by 29 per cent,” reads the statement. “Access to accurate testing is the first step in ending the spread of HIV. While more people are becoming aware of their HIV status, several factors continue to impede this progress. Inadequate testing infrastructure and lack of access to laboratories are among them. Use of dried blood spots for testing ensures that patients in areas with no testing facility can still access the services as the samples can be easily transported.”

UNAIDS’ 95-95-95 goal states that by 2030, 95 per cent of people living with HIV will know their status, 95 per cent of people with diagnosed HIV infection will receive sustained antiretroviral therapy, and 95 per cent of people receiving antiretroviral therapy will have viral suppression.

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