SINGAPORE: Singapore's supplies of COVID-19 antigen rapid self-test (ART) kits under two brands - SD Biosensor and Flowflex - are not affected by the US health authorities' advisory on the products, said the Health Sciences Authority (HSA).
The US Food and Drug Administration had earlier warned against the use of unauthorised versions of SD Biosensor Standard Q COVID-19 Ag Home Test and ACON Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing), saying they may produce false results.
HSA said on Friday (Mar 4) that there can be several versions of antigen rapid self-test 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," it explained.
"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.
"Singapore’s supplies of test kits under these two brands are not impacted by the US FDA’s advisory."
In Singapore, only ART kits that have been authorised by HSA under the Pandemic Special Access Route (PSAR) or received full registration can be supplied, said the agency.
"HSA has evaluated these test kits to meet the required safety, quality and efficacy standards before granting PSAR authorisation or full registration," it added.
HSA also advised consumers to purchase their ART kits from reputable local retailers and pharmacies.
Responding to CNA's queries, Flowflex said its ART kits approved by HSA in Singapore were not affected as they differ from the versions sold in the US and Europe.
The US advisory addresses illegal imports from Europe to the US, said Flowflex. "Product quality or safety has not been the reason for this recall," it added.
No recalls were issued to the Flowflex test kits in Singapore, it said.
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The US Food and Drug Administration had earlier warned against the use of unauthorised versions of SD Biosensor Standard Q COVID-19 Ag Home Test and ACON Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing), saying they may produce false results.
HSA said on Friday (Mar 4) that there can be several versions of antigen rapid self-test 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," it explained.
"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.
"Singapore’s supplies of test kits under these two brands are not impacted by the US FDA’s advisory."
In Singapore, only ART kits that have been authorised by HSA under the Pandemic Special Access Route (PSAR) or received full registration can be supplied, said the agency.
"HSA has evaluated these test kits to meet the required safety, quality and efficacy standards before granting PSAR authorisation or full registration," it added.
HSA also advised consumers to purchase their ART kits from reputable local retailers and pharmacies.
FLOWFLEX KITS NOT AFFECTED
Responding to CNA's queries, Flowflex said its ART kits approved by HSA in Singapore were not affected as they differ from the versions sold in the US and Europe.
The US advisory addresses illegal imports from Europe to the US, said Flowflex. "Product quality or safety has not been the reason for this recall," it added.
No recalls were issued to the Flowflex test kits in Singapore, it said.
Continue reading...