Moves to prevent unapproved Antigen Rapid Test Kits from being sold to public

NOTICE PAPER NO. 784
NOTICE OF QUESTION FOR ORAL ANSWER
FOR THE SITTING OF PARLIAMENT ON 1 NOVEMBER 2021

Name and Constituency of Member of Parliament
Ms Ng Ling Ling
MP for Ang Mo Kio GRC

Question No. 1220

To ask the Minister for Health (a) how did the SG Diagnostics Antigen Rapid Test kits become available in the market when they are meant for professional use in a professional healthcare setting; (b) how many of such kits have been purchased by the public before the recall notice; and (c) how will processes be further tightened to avoid unapproved test kits from being sold in the market.

Written Answer

The Health Sciences Authority (HSA) is currently investigating the unauthorised distribution and supply of SG Diagnostics’ Antigen Rapid Test kits, which are meant for use by healthcare professionals only in a healthcare setting. Appropriate enforcement action will be taken against the responsible parties.

Based on the sales and distribution records by the company, approximately 1,800,000 pieces had been sold by the company from January to September 2021, which includes distribution to professional users and the general public. The number of test kits sold only to the general public is not yet known.

HSA has required SG Diagnostics to issue print advertisements in all four languages to communicate to consumers that its test is not licensed for consumer use and has not been validated for this use, and that all kits purchased should be returned to the company. HSA has also published a list of all COVID-19 tests that have been authorised for self-testing purposes on the HSA website. HSA will continue to work to communicate this list of authorised ART self-test kits and also step up its surveillance of these test kits sold in the market.