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ABBOTT PARK, Ill., May 2, 2019 /PRNewswire/ -- Abbott (NYSE: ABT ) announced today that m-PIMA™ HIV-1/2 VL , the world's first point-of-care viral load diagnostic test, has received the World Health Organization's Prequalification approval (WHO PQ). The test received CE Mark in December 2018 .
"m-PIMA HIV-1/2 VL is the only truly portable molecular point-of-care test designed specifically for use in resource-limited settings such as in sub-Saharan Africa," said Damian Halloran , vice president, Infectious Disease – Emerging Markets, Rapid Diagnostics, Abbott. "With WHO PQ, global funders and ministries of health can now confidently expand access to viral load testing, reaching more people who need the test, with the most compact and efficient point-of-care HIV diagnostic platform available anywhere in the world today."
To provide the most effective HIV treatment and care, the WHO recommends that everyone receiving antiretroviral therapy (ART) undergoes a viral load test at 6 months and 12 months, and annually thereafter, if the individual is stable on ART. Viral load testing is the gold standard for monitoring ART treatment failure. 1 Unfortunately, very few people 2 in resource-limited settings, such as select countries in sub-Saharan Africa, Asia and Latin America , have access to the necessary level of care.
About WHO Prequalification (PQ) WHO Prequalification (PQ) aims to ensure that diagnostics, medicines, vaccines and immunization-related equipment and devices for high burden diseases meet global standards of quality, safety and efficacy, to optimize use of health resources and improve health outcomes.
For more information, go to https://www.who.int/topics/prequalification/en/ .
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1 Roberts, T., Cohn, J., Bonner, K., & Hargreaves, S. (2016). Scale-up of Routine Viral Load Testing in Resource-Poor Settings: Current and Future Implementation Challenges. Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America, 62(8), 1043-1048. http://doi.org/10.1093/cid/ciw001 2 UNAIDS (2014) 90-90-90 An ambitious target to help end the AIDS epidemic. Available on http://www.unaids.org/sites/default/files/media_asset/90-90-90_en_0.pdf