Healthcare firm 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 to reduce 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.
Abbott rapid diagnostics, infectious disease – emerging markets vice president Damian Halloran said: “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.
“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.”
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 scientifically 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.
With operations in around 160 countries, the company produces diagnostic products, nutritionals and branded generic medicines.