Imagine being told you don’t have malaria when, in fact, you do—especially in a remote area where access to medical care is already limited. This chilling scenario is at the heart of a recent international study published in the Malaria Journal, which boldly declares that a widely used rapid diagnostic test for malaria is ‘not fit for purpose.’ But here’s where it gets controversial: while the test has been criticized for delivering too many false-negative results in Southeast Asia, other studies from Africa report better performance. So, is this a regional issue, a flaw in the test itself, or a matter of interpretation? Let’s dive in.
The study, conducted by researchers from the Shoklo Malaria Research Unit (SMRU) at Oxford University’s MORU Tropical Health Network, found that the Abbott-Bioline rapid diagnostic test correctly identified only 18% of Plasmodium falciparum and 44% of Plasmodium vivax infections—alarmingly low rates compared to other rapid tests. These findings have led the authors to call for the test’s removal from the market in Southeast Asia, where malaria affects around 4 million people annually, according to the World Health Organization (WHO).
And this is the part most people miss: the consequences of a false-negative result can be deadly. As Nicholas White, a professor of tropical medicine, starkly puts it, ‘Saying, ‘You don’t have malaria’ to someone with falciparum malaria in a very remote area could be a death sentence.’ This isn’t just about numbers—it’s about lives at stake.
Rapid diagnostic tests are the backbone of malaria control, enabling quick and efficient treatment even in areas without access to laboratory testing. However, the Abbott-Bioline test’s sensitivity has been called into question after multiple false negatives were reported in Southeast Asia. The test, manufactured by Abbott Diagnostics, a subsidiary of the US-based Abbott Laboratories, has been a trusted tool for years. ‘Until recent years, we were very satisfied with these rapid malaria tests,’ White notes. ‘Then we and others started to notice they weren’t working so well.’
One major issue? Faint lines on the test results, which can be easily misinterpreted or missed altogether, especially in low-light conditions. Imagine trying to read a test strip in a dimly lit forest during the monsoon season—it’s nearly impossible. Yet, Abbott maintains that the tests are ‘performing as intended’ and points to multiple studies citing their accuracy. They’re even exploring ways to intensify the test line for clearer results. But critics argue that faint lines increase the risk of errors, potentially compromising malaria surveillance data.
Here’s where it gets even more contentious: While the WHO has reviewed reports of false negatives and faint lines since August 2024, their response has been criticized as slow. The organization issued a public notice in March 2025 to ensure proper test usage and encourage incident reporting, but some argue this isn’t enough. François Nosten, director of SMRU, warns that thousands of people may be affected by wrong results, particularly in Southeast Asia.
So, what’s the way forward? Abbott is conducting new studies on cross-reactivity, label comprehension, and results interpretation, with findings expected by December. The WHO will then review this evidence against prequalification requirements. But in the meantime, the debate rages on: Is the Abbott-Bioline test truly unfit for purpose, or is this a matter of regional variability and user error?
We want to hear from you: Do you think the Abbott-Bioline test should be removed from the market in Southeast Asia? Or is this an overreaction based on regional findings? Share your thoughts in the comments below—let’s spark a conversation that could shape the future of malaria diagnostics.
