Researchers question reliability of Abbott's rapid malaria tests

The World Health Organization (WHO) has sent an internal memo about potential problems with a major company's malaria tests after scientists reported issues with test sensitivity and warned it could delay patients' access to critical treatment. Abbott's Bioline rapid diagnostic tests (RDTs) for malaria are used by health workers around the world, particularly in remote areas where lab techniques such as microscopy and DNA detection aren't available. Investigations at several institutions in Southeast Asia suggest at least some of these RDTs fail to detect infections or show faint test lines for some positive cases. Daniel Ngamije Madandi, director of WHO's Global Malaria Programme (GMP), issued the memo to WHO's six regional offices on 30 April. It lists 11 "affected" lots from two Abbott RDTs--Pf/Pv and Pf/Pan--that were associated with "faint lines and false negative results" in reports from "multiple research groups." The memo follows a public notice by WHO in March that warned of reports of faint lines in malaria RDTs without mentioning particular brands or products.