[UPDATE March 5] SD Biosensor's head of IVD business department Inchul Chung said in a statement on Friday (March 4) that FDA's advisory "is not a warning of our performance or customer safety, but of the illegal importation of Standard Q Covid-19 tests to the US market".
He added: "Standard Q Covid-19 Ag Test has been certified with an excellent performance by CE (Europe), Health Canada (Canada), TGA (Australia) and many other authorities in the rest of the world."
The US Food and Drug Administration (FDA) had on Tuesday (March 1) issued an advisory warning people not to use the SD Biosensor Inc. Standard Q Covid-19 Ag Home Test.
On its website, the FDA explained that it is concerned about the risk of false results when using this test. It advised those who have used the test kit and suspect an inaccurate result to speak to their healthcare providers.
This has gotten some Singaporeans understandably concerned as Antigen Rapid Test (ART) kits from SD Biosensor are sold here.
But the Health Sciences Authority (HSA) in a statement issued on Friday reassured that Singapore's supplies of test kits are not impacted by the US FDA's advisory against the two brands SD Biosensor and Flowflex.
FDA said that it has not received reports of injuries, adverse health consequences, or death associated with the use of the affected SD Biosensor kits. It also said these kits are not authorised, cleared, or approved by the FDA for distribution or use in the US.
This unauthorised test may be packaged in a white and magenta box.
The agency said that it is working with SD Biosensor Inc., a global in-vitro diagnostics company, to resolve this safety issue.
However, FDA added that a separate product, the SD Biosensor Covid-19 At-Home Test, was authorised by the FDA on Dec 24, 2021 and it is "not the subject of this safety communication". This authorised test is distributed by Roche and can still be used.
SD Biosensor, Inc. has initiated a recall for all unauthorised SD Biosensor Standard Q Covid-19 Ag Home Tests that were distributed in the US.
Professor Paul Tambyah, president of the Asia-Pacific Society of Clinical Microbiology and Infection, told AsiaOne earlier on Friday that "as far as we know, this [FDA advisory] does not apply to the kits distributed in Singapore which fall under the US FDA’s Emergency Use Authorisation (EUA)".
He added that supplies in Singapore have been authorised by the HSA and that "we should not stop using them".
In its statement, HSA said that only self-test kits that have been authorised by them 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," it said.
The agency explained that there can be several versions of antigen rapid self-test kits supplied under the same manufacturer's brand, and companies and the differences between different versions include labelling and/or packaging.
It said that 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," added the agency.
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 here.
*This article was updated on March 5, 9am.