S’pore’s ART Kits Are Safe For Use & Not Affected By US FDA’s Warning: HSA

Only ART Kits Authorised By HSA Can Be Supplied In S’pore

As Covid-19 spreads across Singapore, it’s become a daily routine for many to test themselves with Antigen Rapid Test (ART) kits.

The most commonly used one in Singapore is by SD Biosensor Standard Q, with Flowflex also available.

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However, Singaporeans were concerned when the United States (US) Food and Drug Administration (FDA) warned against using these 2 ART kits.

The Health Sciences Authority (HSA) has quickly assured that these 2 brands are safe for use in Singapore and not affected by the FDA’s warning.

All ART kits in Singapore authorised by HSA

In a press release on Friday (4 Mar), the HSA acknowledged the FDA warnings about the 2 ART kit brands.

As they’ve received several enquiries as a result, the HSA said all ART kits supplied in Singapore have been authorised by them.

To be granted authorisation under the Pandemic Special Access Route (PSAR) or full registration, they have to be evaluated by HSA.

The evaluation ensures that they meet “the required safety, quality and efficacy standards”.

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‘Not authorised’ by the FDA

Why then, did the FDA warn against using the 2 brands?

The advisories against SD Biosensor and Flowflex, issued on Tuesday (1 Mar), said they were “not authorised, cleared, or approved by the FDA for distribution or use in the United States”.

The agency also added,

The FDA is concerned about the risk of false results when using this unauthorized test.

However, they hadn’t received any reports of injuries, adverse health consequences, or death suffered by those who used the tests.

Advisories not related to safety or accuracy issues: HSA

Singapore’s HSA explained that the FDA had issued the advisory because some versions of the ART kits had not been evaluated and authorised.

This doesn’t mean that there’s any danger of inaccurate results, with HSA emphasising that that the warnings “are not related to any specific quality, safety or accuracy issues”.

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Furthermore, a manufacturer may supply many versions of ART kits under their brand.

Thus, the company may apply for authorisation of only specific versions in a certain country, which may be different for other countries.

These versions may vary in how they’re labelled and/or packaged, the HSA said.

Singapore’s ART kits not affected by FDA advsiory

Hence, Singapore’s supplies of ART kits under SD Biosensor and FlowFlex are “not impacted by the US FDA’s advisory”.

Users will be safe as long as we buy our ART kits from reputable local retailers and pharmacies.

So far, 16 brands of ART kits have been authorised in Singapore. Check out the full list here.

FDA warning was for US market

An SD Biosensor spokesman told The Straits Times (ST) that the FDA’s warning was more to do with the illegal importation of their ART kits to the US.

SD Biosensor’s local distributor also added that there’s no recall for SD Biosensor ART kits in Singapore.

Flowflex’s distributor also told ST that their ART kits in Singapore aren’t affected by any recall, as our version differs from the US and Europe versions.

Singapore’s version is distributed by Alcotech, and the company’s name and address is clearly visible on the side of the box.

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Alcotech’s spokesman added that the FDA’s recall was to protect US consumers from the 200,000 illegally exported kits from Europe, as they haven’t gone through the correct supply chain.

Safe & accurate ART kits are essential

ART kits have undoubtedly become an important tool of our fight against Covid-19.

Thus, it’s essential that they’re safe and accurate for use, and it’s good that the HSA has cleared up our worries over them.

Let’s hope that the Covid-19 nightmare will end sooner rather than later so we won’t have to use them so often.

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Featured image adapted from Mohd Yazed on Facebook and NTUC FairPrice on Facebook.