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).

2        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.

3        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.  

4        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.

5        Singapore’s supplies of test kits under these 2 brands* are not impacted by the US FDA’s advisory.

6        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/consumer-safety/articles/details/covid19_selftests.

4 MARCH 2022

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* The US FDA had issued announcements on the following test kits: "SD Biosensor STANDARD Q COVID-19 Ag Home Tests" and "ACON Flowflex COVID-19 Tests".

Consumer, Healthcare professional, Industry member, Medical devices

HSA Updates

4 Mar 2022