Abbott secures WHO prequalification approval for HIV point-of-care test

Abbott has secured World Health Organization’s prequalification approval (WHO PQ) for its m-PIMA HIV-1/2 VL point-of-care viral load diagnostic test. The company received CE mark approval for m-PIMA HIV-1/2 VL point-of-care test in December 2018. The m-PIMA HIV-1/2 VL is a quantitative nucleic acid amplification test for viral load measurement of HIV type-1 groups M/N and O, and HIV-2 in plasma samples. As the platform is portable, it can be used even at remote locations.

Abbott has designed the HIV point-of-care test for the measurement of viral load in under 70 minutes, while the patient is still present. It helps people to receive results during the same visit and enables immediate treatment decisions, allowing reducing the number of people lost to follow-up.

The quick turnaround time of the test is more useful for monitoring the viral load of HIV-positive pregnant women, as well as in cases of suspected HIV treatment failure. The m-PIMA HIV-1/2 VL is part of the firm’s comprehensive portfolio of diagnostic solutions for HIV screening, monitoring and viral load management. 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.

WHO PQ aims to assure that diagnostics, medicines, vaccines, and immunization-related equipment and devices for risk diseases meet global standards of quality, safety, and efficacy. The prequalification process includes a transparent and scientific evaluation, comprising of dossier review, consistency testing or performance evaluation, and site visits to manufacturers. Abbott provides a range of critical tools to help healthcare providers make informed treatment decisions to treat patients with HIV.