By Cheruto Valentine

The World Health Organization (WHO) has granted Abbott Laboratories, an American health care company, prequalification approval (PQ) for the world’s first HIV point-of-care viral load diagnostic test.

WHO prequalification approval confirms that the m-PIMA™ HIV-1/2 VL, as the Abbott test product is called, meets global standards of quality, safety and efficacy.

“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, Abbott’s Vice President of Infectious Disease – Emerging Markets and Rapid Diagnostics.

This test is the most effective method of assessing the response of HIV infected patients to anti-retroviral therapy (ART). The WHO recommends that anyone undergoing ART should receive a viral load test 6 months and 12 months into the therapy; then annually afterwards if the patient is stable on ARTs.

Viral load testing monitors individual response to treatment and gauges the effectiveness of medication. It also tracks the emergence of resistance in HIV-positive people. It is therefore considered the gold standard of care for HIV patients. However, most people living in countries with resource-limited settings do not have access to this required level of healthcare.

According to Abbott, the platform is portable and can therefore be moved easily to extremely remote locations. It measures an individual’s viral load in less than 70 minutes; which increases immediacy of treatment decisions by reducing patients’ follow-up visits. Being that it is a procedure that can be concluded in the presence of the patient, it also minimizes the eventuality of patients not getting their results because they were unable to make follow-up visits.

“The integration of point-of-care viral load solutions in healthcare networks will be instrumental in achieving UNAIDS’ 90-90-90 goals,” said Professor Matilu Mwau, Director at the Center for Infectious and Parasitic Diseases Control Research, Kenya Medical Research Institute (KEMRI) in Busia, Kenya.

The WHO PQ is used by procurement agencies in making purchasing decisions for medicines and/or vaccines. The assessment of products valid for prequalification includes performance evaluation and site visits to manufacturers.

Abbott’s m-PIMA HIV-1/2 VL also received CE marking in December 2018. CE marking is a certification mark that indicates conformity with health, safety and environmental protection standards for products that are manufactured in, or designed to be sold within the European Economic Area.