The first ever point-of-care test for HIV viral load has been pre-approved by the World Health Organisation (WHO).
m-PIMA, the world's first point-of-care viral load diagnostic test, has received Prequalification approval (WHO PQ). This follows the CE Marking which it received in December 2018. It was developed by Abott.
"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.
The use of m-Pima is expected to ease the hassle of viral load testing especially in areas where it would take long to access testing equipment.
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Halloran said, "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. Unfortunately, very few people in resource-limited settings, such as select countries in sub-Saharan Africa, Asia and Latin America, have access to the necessary level of care.
The platform is portable so it can be brought into the most remote locations. It’s easy to use, deployable at the point of care and designed to measure viral load in under 70 minutes, while the patient is still present.
This allows people to receive results during the same visit and enables immediate treatment decisions, thereby reducing the number of people lost to follow-up.
The test’s quick turnaround time is particularly valuable for monitoring the viral load of HIV-positive pregnant women and in cases of suspected HIV treatment failure.
The m-PIMA HIV-1/2 VL is part of Abbott’s comprehensive portfolio of diagnostic solutions for HIV screening, monitoring and viral load management.
From the core lab to the point of care, Abbott provides critical tools to help healthcare providers make informed treatment decisions for people living with HIV.
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 the use of health resources and improve health outcomes.