FDA issues warning against using certain unauthorised Covid-19 ART kits from SD Biosensor

The US Food and Drug Administration (FDA) issued an advisory warning people not to use the SD Biosensor Inc. Standard Q Covid-19 Ag Home Test on Tuesday (March 1). Antigen rapid test (ART) kits from SD Biosensor are sold in Singapore. On its website, the FDA explained that it is concerned about the risk of false results when using this test. It is also not authorised, cleared, or approved by the FDA for distribution or use in the United States. This unauthorised test may be packaged in a white and magenta box (see image above). The agency added that it has not received reports of injuries, adverse health consequences, or death associated with the use of this test. Those who've used the test kit and suspect an inaccurate result are advised to speak to their healthcare providers, said FDA, an agency within the US Department of Health and Human Services. It said that it is working with SD Biosensor Inc., a global in-vitro diagnostics company, to resolve this safety issue. However, the agency 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 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 Health Sciences Authority (HSA) and that "we should not stop using them". AsiaOne has contacted HSA, the national regulator of health products in Singapore, for comments. This article was first published in Asia One . All contents and images are copyright to their respective owners and sources. Khmer Daily