Ensuring Accuracy given different brands of Antigen Rapid Test Kits

NOTICE PAPER NO. 799
NOTICE OF QUESTION FOR ORAL ANSWER
FOR THE SITTING OF PARLIAMENT ON 1 NOVEMBER 2021

Name and Constituency of Member of Parliament
Mr Sharael Taha
MP for Pasir Ris-Punggol GRC

Question No. 2030

To ask the Minister for Health given the latest protocol on increased testing for COVID-19 using self-procured 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 antigen rapid test (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.

Written Answer

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.