If you have SD Biosensor and Flowflex antigen rapid test (ART) kits, they are still safe and fit for use in Singapore.
This comes after the US Food and Drug Administration (FDA) issued a warning on 1 March to stop using the kits as they haven’t been approved in the US.
Here’s what happened.
HSA Approved Test Kits Though US’ FDA Did Not
The FDA said that the test kits were not authorised, cleared or approved for distribution and use in the US. They also brought up concerns of false results and have recalled the test kits, although it has not received any reports linked to the products.
Singapore’s Health Sciences Authority (HSA) said that it has received inquiries on whether Singapore’s supplies of the two test kits were affected by the FDA’s advisory.
The two test kits are the SD Biosensor Standard Q Covid-19 Ag Home Test and Acon Laboratories Flowflex Sars-CoV-2 Antigen Rapid Test (Self-Testing) kits. They are both sold in Singapore.
The HSA said that they have evaluated these kits to meet the required safety, quality and efficacy standards, before granting them Pandemic Special Access Route Authorisation or full registration.
So no, our supplies of test kits are not impacted by the FDA’s advisory. If you were going to throw them out, feel free to continue using them.
And if you tested positive using these kits and were hoping the kits were defective…it’s time to start isolating yourself.
Why Did Singapore Approve The Kits, But The US Didn’t?
HSA explained that there can be many versions of ART kits supplied under the same brand. This can vary in how the products are packaged and labelled.
Additionally, the FDA’s warnings were not related to any specific quality, safety or accuracy issues. Instead, the kits were recalled due to illegal exports, which didn’t pass through FDA’s checks.
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A spokesman for Alcotech, which is the local distributor of Flowflex ART kits, said that European traders illegally exported 200,000 European-approved kits to the US.
When it is illegally exported, the kits do not go through the correct medical device supply chain. This makes it difficult for the FDA to ensure that the kits are safe for use.
That’s the main reason why the FDA had recalled that batch of test kits from the US markets. However, the Singapore HSA-approved version is legally imported and had gone through HSA’s checks. There is thus no need to worry about the news of FDA’s recall.
Consumers should buy ART kits from reputable local retailers and pharmacies, so that they know the kits they use are approved. There are 16 COVID-19 ART kits approved for use in Singapore.
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Featured Image: SD Biosensor and Acon Labs
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