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WHO Prequalifies Abbott HIV Viral-Load POC Test

NEW YORK (GenomeWeb) – Abbott said today that it has received World Health Organization prequalification approval for its m-Pima HIV-1/2 VL viral load diagnostic test, a portable molecular point-of-care platform for use in resource-limited settings such as in sub-Saharan Africa.

The m-Pima HIV-1/2 VL is a quantitative nucleic acid amplification test for viral load measurement in plasma samples of HIV type 1 groups M/N and O, and HIV-2.

The platform can be deployed in the most remote locations and at the point of care to measure viral load in under 70 minutes, allowing people to receive results during the same visit and enabling immediate treatment decisions, which can reduce the number of people lost to follow-up, the firm said.

Abbott noted that the test's quick turnaround time is particularly valuable in cases of suspected HIV treatment failure and for monitoring the viral load of HIV-positive pregnant women.

"With WHO [prequalification], global funders and ministries of health can now confidently expand access to viral load testing, reaching more people who need the test," Damian Halloran, vice president of infectious disease in emerging markets for Abbott Rapid Diagnostics, said in a statement.

To provide the most effective HIV treatment and care, the WHO recommends that everyone receiving antiretroviral therapy (ART) undergoes a viral load test at six 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. 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, said Abbott, citing UNAIDS, a joint United Nations program on HIV and AIDS.

The m-Pima HIV-1/2 VL viral load test received CE marking in December 2018.

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