Study finds Abbott-Bioline malaria test gives many false negatives ^{CEFR B1}

Rapid diagnostic tests are an important tool to treat malaria quickly and close to home, particularly in remote areas without laboratory services. The Shoklo Malaria Research Unit (SMRU), part of Oxford University's MORU Tropical Health Network, carried out a study on the Thailand–Myanmar border between October 2024 and January 2025. The team compared the Abbott-Bioline rapid test with another rapid test and with microscopy.

SMRU reported that Abbott-Bioline correctly identified only 18 per cent of Plasmodium falciparum infections and 44 per cent of Plasmodium vivax infections that microscopy had confirmed. The researchers said many positive samples produced only a faint line on the device, even when patients had fever. The study authors wrote that the test "failed to detect microscopically confirmed cases of malaria and is not fit for purpose" and called for its removal from the market in Southeast Asia. SMRU director François Nosten said thousands of people may be affected by wrong results, and co-author Nicholas White warned a false negative for falciparum malaria in a remote area could be a death sentence.

Responses varied. Abbott Diagnostics said a company review found the tests were "performing as intended" and that a WHO-qualified lab confirmed its findings. Other studies gave a mixed picture, and some research from Africa reported better performance. WHO has reviewed reports of false negatives and faint lines since August 2024, issued a public notice on 31 March 2025 and carried out a site inspection that did not find cause to delist the product. The manufacturer said new studies are under way, with results expected by December; WHO will review the new evidence against prequalification requirements.