Malaysia: MDA Issues Advisory on Malaria Test Kit

The World Health Organization (WHO) released a notification regarding the performance of certain malaria diagnostic test kits, which has raised concerns across the healthcare system globally. Recently, the WHO received reports from several countries indicating some malaria test kits have shown faint positive test lines in patients who were confirmed to have malaria. This discrepancy could potentially affect diagnosis accuracy and treatment decisions, posing a significant risk in malaria-endemic regions.

In response to this issue, the Medical Device Authority (MDA) urged all healthcare establishments and MedTech stakeholders to take this matter seriously. The MDA emphasized the importance of post-market surveillance to ensure the performance and safety of these malaria test kits.

All involved parties are reminded to:

• Closely monitor the test kits in use

• Report any irregularities or performance concerns

• Follow WHO’s usage recommendations, according to instructions, updates, or guidelines provided

  
  

Malaria remains a global health priority, and reliable diagnostics are a cornerstone of effective control and treatment strategies. This situation highlights the critical role of quality assurance, regulatory oversight, and collaboration between health authorities, manufacturers, and users in ensuring patient safety.

All MedTech developers, manufacturers, distributors, diagnostic providers, and healthcare professionals are kindly reminded to uphold the highest standards in product safety and performance.

Stay informed with ARQon for further regulatory updates and healthcare advisories.

Source: Medical Device Authority (MDA)