WHO information notice for users of malaria IVDs 2025/1

Published on April 7, 2025

In 2024, the World Health Organization (WHO) was informed that various malaria rapid diagnostic tests (RDT) showed faint positive test lines for patients with confirmed malaria infection. Incidents were reported in several countries for various products detecting both Plasmodium falciparum and Plasmodium vivax, and products detecting Plasmodium falciparum and pan species. 

The faint test lines were predominantly observed for patients with low parasitemia (200 parasites/µl). However, some patients with higher parasitemia also generated faint test lines. More recent reports indicated that faint test lines have led to misdiagnosis and therefore delayed appropriate treatment. The manufacturers' investigations have followed internationally recognized practices.     

Read about the risks and actions to be taken in the medical product alert

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