US FDA warns against use of unauthorised Covid-19 antigen tests including SD Biosensor, Flowflex kits

SINGAPORE — The United States Food and Drug Administration (FDA) has warned people against the use of unauthorised versions of certain Covid-19 rapid antigen tests currently being marketed in the country.

The kits named include SD Biosensor Standard Q Covid-19 Ag Home Test and ACON Flowflex Sars-CoV-2 Antigen Rapid Test (Self-Testing). Both brands are currently available in Singapore.

These tests have not been authorised, cleared or approved by the FDA for distribution or use in the United States, the US health agency said in an advisory dated March 1, adding that they may show false results.

The warning was also issued against unauthorised versions of Celltrion USA's DiaTrust Covid-19 Ag Rapid Test.

The authorised versions of the tests can continue to be used, but consumers should compare the packaging to make sure they do not buy unauthorised tests, the FDA said.

There are currently 16 Covid-19 self-test kits approved for use in Singapore under the Pandemic Special Access Route (PSAR). Of these, four are made by SD Biosensor and one by ACON.

CNA has contacted Singapore's Ministry of Health, the Health Sciences Authority, retailers and kit manufacturers for more information.

As of Friday, both the SD Biosensor and ACON Flowflex kits cited by the FDA remain available for sale in Singapore.

The US FDA said it has not received reports of injuries, adverse health consequences or death associated with the use of these unauthorised tests.

All three companies have initiated a recall for all unauthorised tests that were distributed in the United States.

Antigen tests require a nasal or throat swab and can produce results more quickly than molecular tests, which detect genetic material in the virus. However, antigen tests are considered less accurate. CNA