SD Biosensor, Flowflex antigen rapid test kits safe for use here: HSA

The Health Sciences Authority (HSA) has said SD Biosensor and Flowflex antigen rapid test (ART) kits linked to a recall in the United States are safe and fit for use in Singapore.

Its statement yesterday comes after the US Food and Drug Administration (FDA) issued a warning on Tuesday for people to stop using some versions of the test kits because they have not been approved in the US.

HSA said it received several inquiries on the US advisory, which related to the SD Biosensor's Standard Q Covid-19 Ag Home Test and Acon Laboratories' Flowflex Sars-CoV-2 Antigen Rapid Test (Self-Testing) kits. It said: "Singapore's supplies of test kits under these two brands are not impacted by the FDA's advisory."

The kits that are sold here meet the required safety, quality and efficacy standards set before they were approved here, it said.

In separate notices on both test kits, the FDA said on Tuesday that the kits were not approved for use in the US and that it was concerned about the risk of false results when using the unauthorised test kits. The FDA said the distributors have initiated a recall for all unauthorised kits in the US.

HSA said there can be many versions of ART kits supplied under the same manufacturer's brand, which can vary in how the products are packaged and labelled.

"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," HSA said.

"The FDA's announcements are not related to any specific quality, safety or accuracy issues."

In a statement yesterday, Mr Inchul Chung, a business head at SD Biosensor, said: "The post on the US FDA website is a warning of the illegal importation of Standard Q-branded Covid-19 tests to the US market."

A spokesman for SPD Scientific, SD Biosensor's local distributor, said: "There is no recall for SD Biosensor test kits in Singapore.

"We have not been informed by SD Biosensor on quality or accuracy issues."

A spokesman for Alcotech, the local distributor of Flowflex ART kits, said the kits in Singapore were not affected by the recall.

"A group of rogue traders in Europe illegally exported around 200,000 European-approved tests to the US. When this happens, the ART kits do not go through the correct medical device supply chain, which makes it difficult for the FDA to ensure accountability."

The FDA then issues a recall of this specific batch of test kits from the US market in order to protect its consumers, he said.

"The Singapore HSA-approved version differs from both the US and Europe versions and is not affected by this recall."

There are currently 16 Covid-19 self-test kits approved for use in Singapore.