The World Health Organization has granted prequalification to Abbot's point-of-care test of HIV viral load.
WHO's action confirms the diagnostic, m-PIMA HIV-1/2 VL, meets its quality, safety and efficacy standards, potentially giving ministries of health and other funders the confidence to buy the test.
Abbott said the diagnostic can expand access to viral load testing in resource-limited settings and, by extension, improve management of HIV.
WHO advises people on antiretroviral therapy (ART) to undergo a viral load twice in the year they start treatment and annually after that. This testing regimen is designed to monitor adherence to ART treatment and minimize failure, but the cost and complexity of viral load testing has stopped healthcare systems in parts of the world from providing widespread access to diagnostics.
Global demand for viral load diagnostics is expected to grow rapidly in coming years resulting in a forecast annual requirement of 28.5 million tests by 2021. While testing capacity is scaling up, observers expect it to continue to fall short of demand.
The m-PIMA HIV-1/2 VL can help to make up the shortfall, Abbott said. The test uses quantitative nucleic acid amplification to measure the viral load of multiple types of HIV virus in plasma samples. Notably, the platform is portable and easy to use, making it suitable for deployment in remote, resource-limited settings such as parts of sub-Saharan Africa, Abbott said.
The test provides results within 70 minutes enabling a healthcare professional to perform the test and make treatment decisions based on the results during the same visit, cutting the risk of lack of follow-up.
Abbott secured a European CE mark for the test in December. The WHO prequalification builds on that clearance and will inform the procurement decision of United Nations agencies and WHO member states.
"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," Damian Halloran, VP of infectious disease, emerging markets, rapid diagnostics at Abbott, said in a statement.