Rapid diagnostic tests are vital for giving quick treatment and for care in remote areas without laboratory services. The World Health Organization estimates that around 4 million people a year are affected by malaria in Southeast Asia, where the Abbott-Bioline test is widely used. Researchers from the Shoklo Malaria Research Unit (SMRU), part of Oxford University’s MORU Tropical Health Network, studied the test on the Thailand–Myanmar border between October 2024 and January 2025 and compared it with another rapid test and with microscopy.
The SMRU team found 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. Many positive cases produced only a faint line on the device, even when patients had fever. The authors concluded 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 may be affected by wrong results, and co-author Nicholas White warned that telling someone with falciparum malaria they do not have the disease in a remote area could be a death sentence.
Responses from manufacturers and other researchers were mixed. Abbott Diagnostics said a company review found the tests were "performing as intended" and that a WHO-qualified laboratory confirmed the company findings. Some studies in Africa reported better performance, while a study cited by Sunday Atobatele covering Nigeria, Uganda and Benin found that Abbott’s Bioline and the First Response test showed higher rates of results changing over time; faint lines, he said, increase the risk of misinterpretation and misrecording and highlight the need for training, supervision and validation.
WHO told SciDev.Net it has reviewed reports of false negatives and faint lines since August 2024, issued a public notice on 31 March 2025 and a technical note to advisers. WHO worked with Abbott Diagnostics Korea and carried out a site inspection that did not find cause to delist the product. The manufacturer said new studies on cross-reactivity, label comprehension and results interpretation are under way, with results expected by December; WHO will review that evidence and assess it against prequalification requirements.
- cross-reactivity
- label comprehension
- results interpretation
Difficult words
- rapid diagnostic test — device for quick illness detection outside laboratoriesRapid diagnostic tests
- microscopy — examination of samples using a microscope
- false negative — test result that wrongly shows no diseasefalse negatives
- cross-reactivity — reaction causing a test to react to similar substances
- prequalification — official approval before a product is accepted
- faint line — very weak visible signal on a test devicefaint lines
- delist — remove from an official list or market
Tip: hover, focus or tap highlighted words in the article to see quick definitions while you read or listen.
Discussion questions
- How might faint or changing test lines increase the risk of wrong diagnosis in remote health settings? Give reasons or examples.
- If studies find different performance in Africa and Southeast Asia, what factors could explain those differences?
- What steps should health authorities and manufacturers take when a commonly used diagnostic test shows poor results in some studies?
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