Ensuring Accuracy Given Different Brands of Antigen Rapid Test Kits
Ministry of HealthSpeakers
Summary
This question concerns the regulation of quality and pricing for various brands of antigen rapid test (ART) kits sold in the local market. Mr Sharael Taha asked how the accuracy of these kits is ensured and how the Ministry prevents manufacturers from profiteering. Minister for Health Ong Ye Kung explained that all legal kits must be authorized by the Health Sciences Authority under the Pandemic Special Access Route following stringent analytical and clinical validations. He highlighted that the Ministry of Health monitors the ongoing performance of these kits and encourages market competition to ensure a diversified supply. The Minister concluded that prices are closely monitored and there have been no reports of businesses profiteering from the sale of ART kits.
Transcript
93 Mr Sharael Taha asked the Minister for Health given the latest protocol on increased testing for COVID-19 using self-procured antigen rapid test (ART) kits and that many different brands of ART test kits are now sold online and offline (a) how does the Ministry ensure that the quality and accuracy of ART kits are maintained among the different brands sold; and (b) how does the Ministry ensure that the manufacturers are transferring the benefits from the economies of scale to the consumer and not overly profiteering from the sale of ART kits.
Mr Ong Ye Kung: All self-test ART kits currently available legally in the local market have to be authorised by the Health Sciences Authority (HSA) under the Pandemic Special Access Route (PSAR). MOH and HSA have put together a robust process to ensure that the self-test ART kits introduced into our local market meet and maintain stringent quality standards.
MOH conducts analytical and clinical validations of the test kits, supported by our healthcare institutions and the Diagnostics Development Hub. Only tests that meet our stringent validation requirements are authorised under PSAR by HSA.
After tests have been authorised and are in use, MOH continues to monitor the performance of these ART kits. HSA also ensures that only ARTs authorised by HSA are being sold for self-testing purposes.
To ensure adequate market competition and diversification of supply, MOH continues to evaluate ART kits and to bring those of good quality into the local market. We also keep a close watch on prices, but to date, we have not observed nor received reports of businesses profiteering from the sale of ART kits.