On March 31, 2025, the World Health Organization (WHO) issued an advisory regarding performance concerns with certain malaria rapid diagnostic test kits (RDTs). WHO has received multiple reports indicating faint positive test lines observed in patients confirmed to have malaria, potentially affecting test reliability across several countries using these kits.
In this regard, the Medical Device Authority (MDA) advises all establishments to give serious attention to this matter by carrying out their respective post-market responsibilities, including ensuring the performance and safety of these test kits. In addition, users are advised to handle malaria test kits according to the recommendations stipulated in the WHO notification.
For detailed information and specific recommendations, refer to the official WHO notification available here: WHO Information Notice for Users of Malaria IVDs (2025)
Effective Date: Immediately, as per WHO’s notification dated March 31, 2025.
Implications to Clients
Establishments must verify the reliability of malaria RDTs in use and ensure staff are trained to correctly interpret results to avoid misdiagnosis.
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