Malaria rapid diagnostic test ‘not fit for purpose’

 An international study published in the Malaria Journal claims that a widely used test for detecting malaria is delivering too many inaccurate false-negative results and is “not fit for purpose”.

The study authors are calling for the removal of the test—the Abbott-Bioline rapid diagnostic test—from the market in Southeast Asia where it is widely deployed and where around 4 million people a year are affected by malaria, according to the World Health Organization (WHO).

Researchers from the Shoklo Malaria Research Unit (SMRU), part of Oxford University’s MORU Tropical Health Network, found that the test correctly identified only 18 per cent of Plasmodium falciparum and 44 per cent of Plasmodium vivax infections—considerably lower rates than other brands of rapid tests.

Many of the tests only showed a faint line to identify positive cases, even where the patient was showing signs of fever.

However, other studies from Africa have reported better performance of the same test.

“Malaria is a major cause of illness and an important cause of death where we work,” said study co-author Nicholas White, a professor of tropical medicine at Mahidol University, Bangkok and at the University of Oxford’s Centre for Tropical Medicine and Global Health.

“Saying, ‘You don’t have malaria’ to someone with falciparum malaria in a very remote area could be a death sentence,” he told.

Rapid diagnostic tests are the mainstay of malaria control, the study stressed, allowing malaria to be treated near home, quickly and efficiently, even in remote areas where laboratory testing is unavailable.

However, the sensitivity of the Abbott-Bioline test was called into question after researchers working with the SMRU in Southeast Asia reported multiple false negatives. The test is made by Abbott Diagnostics, part of the US multinational company Abbott Laboratories.

“Until recent years we were very satisfied with these rapid malaria tests, then we and others started to notice that they were not working so well,” said White. He stressed that he and his colleagues have diagnosed and treated “hundreds of thousands of patients” over a number of decades.The study was conducted between October 2024 and January 2025, on the Thailand-Myanmar border, where until recent conflict, falciparum malaria was close to elimination.

It compared the performance of the Abbott-Bioline test with another rapid diagnostic test and microscopy tests.

The Abbott-Bioline test, the researchers concluded, “failed to detect microscopically confirmed cases of malaria and is not fit for purpose”.

Source: SciDev.Net.