The US FDA recently made an annoucement about certain Covid-19 ART self-test kits being unauthorised and presenting false results.
MOH and HSA has since released a statement allaying fears about the announcements by the FDA.
Here is their statement
𝐇𝐒𝐀 𝐔𝐩𝐝𝐚𝐭𝐞𝐬 𝐨𝐧 𝐑𝐞𝐜𝐞𝐧𝐭 𝐔𝐒 𝐅𝐃𝐀 𝐀𝐧𝐧𝐨𝐮𝐧𝐜𝐞𝐦𝐞𝐧𝐭𝐬 𝐚𝐛𝐨𝐮𝐭 𝐂𝐞𝐫𝐭𝐚𝐢𝐧 𝐂𝐎𝐕𝐈𝐃-𝟏𝟗 𝐀𝐧𝐭𝐢𝐠𝐞𝐧 𝐑𝐚𝐩𝐢𝐝 𝐒𝐞𝐥𝐟-𝐓𝐞𝐬𝐭 𝐊𝐢𝐭𝐬
The Health Sciences Authority (HSA) has received several enquiries on the recent antigen rapid self-test kit announcements by the United States Food and Drug Administration (US FDA).
In Singapore, only COVID-19 antigen rapid self-test kits that have been authorised by HSA under the Pandemic Special Access Route (PSAR) or full registration can be supplied. HSA has evaluated these test kits to meet the required safety, quality and efficacy standards before granting PSAR authorisation or full registration.
There can be several versions of antigen rapid self-test kits supplied under the same manufacturer’s brand. Companies may seek marketing authorisation of specific versions in different countries. The differences between different versions include labelling and/or packaging.
The US FDA has advised people to stop using some versions of the test kits because they have not been evaluated and authorised by the US FDA. The US FDA’s announcements are not related to any specific quality, safety or accuracy issues.
Singapore’s supplies of test kits under these 2 brands are not impacted by the US FDA’s advisory.
Consumers are advised to purchase their antigen rapid self-test kits from reputable local retailers and pharmacies. The full list of COVID-19 self-test kits HSA has authorised for use in Singapore can be found at https://www.hsa.gov.sg/…/arti…/details/covid19_selftests