The US Food and Drug Administration (US FDA) warned against the use of unauthorised versions of two brands of antigen rapid test (ART) kits.
The two brands are SD Biosensor Standard Q Covid-19 Ag Home Test and ACON Flowflex SARS-CoV-2 ART (Self-Testing), which are retailed in Singapore as well.
In an advisory issued on Mar. 1, the US FDA said it is concerned about “the risk of false results when using this unauthorised test”.
Test kits supplied in Singapore meet safety, quality and efficacy standards
In response, Singapore’s Health Sciences Authority (HSA) said only Covid-19 ART kits that have been authorised by HSA under the Pandemic Special Access Route (PSAR) or full registration can be supplied.
HSA assured that these two brands can be used and the supplies of these test kits are not impacted by the US FDA’s advisory.
HSA added that they have evaluated these test kits meet the required safety, quality and efficacy standards before granting PSAR authorisation or full registration.
In response to CNA, Flowflex clarified that the test kits sold in Singapore are not the same as the ones retailed in Europe and the U.S.
Users can identify the version sold in Singapore by the label on the box which indicates the distributor as Alcotech.
Why US FDA issued such an advisory?
HSA explained that there can be several versions of ART 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.
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, HSA added.
Consumers are advised to purchase their antigen rapid self-test kits from reputable local retailers and pharmacies.
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