Professionals only: Malaysia's first mpox test kit approved for accurate diagnosis

The Medical Device Authority (MDA) in Malaysia has recently approved the first monkeypox (mpox) test kit, specifically designed for use by healthcare professionals. This approval marks a significant step in the fight against mpox, a disease that has seen a resurgence in recent years. The test kit is a critical tool for accurate diagnosis, but its use is restricted to professionals to ensure reliability and prevent the spread of the virus due to mishandling.

Mpox, also known as monkeypox, is a viral zoonosis with symptoms similar to those seen in the past in smallpox patients, although clinically less severe. The disease is caused by the monkeypox virus, a member of the Orthopoxvirus genus. Accurate and timely diagnosis is crucial for managing and controlling outbreaks. The preferred method for diagnosing mpox is through the detection of viral DNA using polymerase chain reaction (PCR) technology, which is known for its high sensitivity and specificity.

The Role of the MDA in Regulating Test Kits

The MDA plays a pivotal role in ensuring that medical devices, including diagnostic test kits, meet stringent safety and efficacy standards before they are approved for use. The approval process involves a comprehensive evaluation to ensure that the test kits provide accurate and reliable results. The MDA's decision to approve the mpox test kit for professional use only underscores the importance of handling these kits correctly to avoid inaccurate results and potential virus spread.

Why Restrict the Use to Professionals?

The restriction of the mpox test kit to authorized professionals is a precautionary measure to prevent errors in testing and interpretation. Dr. P Muralitharan, the CEO of MDA, emphasized that improper handling of the test kits by untrained individuals could lead to false results, which may inadvertently contribute to the spread of the virus. This professional-only restriction ensures that the test results are reliable and that any positive cases are managed appropriately by healthcare providers.

Comparative Insights: Mpox Testing in the U.S.

In contrast to Malaysia's professional-only approach, the U.S. has seen the approval of at-home mpox test kits under emergency use authorization by the FDA. Labcorp's Mpox PCR Test Home Collection Kit allows patients to collect samples at home, providing convenience and privacy. However, these kits are still ordered by physicians and require samples to be sent to certified laboratories for analysis. This approach highlights a different strategy in making testing accessible while maintaining professional oversight.

Implications for Public Health and Future Outbreaks

The approval of the mpox test kit by the MDA is a proactive measure to enhance the country's diagnostic capabilities and readiness for potential outbreaks. By ensuring that only trained professionals handle the test kits, the MDA aims to maintain high testing standards and prevent the spread of mpox. This strategy is crucial in managing public health risks associated with infectious diseases like mpox.

According to a statement from the MDA, "If the mpox test kit is not handled by professionals, there is a possibility of inaccurate results and may cause the virus to spread among the population". This highlights the agency's commitment to ensuring that diagnostic tools are used correctly to protect public health.

The MDA's approval of the first mpox test kit for professional use is a significant milestone in Malaysia's public health landscape. By restricting the use to authorized professionals, the MDA ensures the accuracy and reliability of test results, which is essential for effective disease management and control. As the world continues to grapple with emerging infectious diseases, such measures are vital in safeguarding public health and preventing widespread outbreaks.