25.7 C
Singapore
Thursday, December 1, 2022
Ads

MOH RESPONDS TO U.S FDA’S ANNOUNCEMENT ABOUT ART KITS

The US FDA recently made an annoucement about certain Covid-19 ART self-test kits being unauthorised and presenting false results.

Advertisements

MOH and HSA has since released a statement allaying fears about the announcements by the FDA.

Here is their statement

๐‡๐’๐€ ๐”๐ฉ๐๐š๐ญ๐ž๐ฌ ๐จ๐ง ๐‘๐ž๐œ๐ž๐ง๐ญ ๐”๐’ ๐…๐ƒ๐€ ๐€๐ง๐ง๐จ๐ฎ๐ง๐œ๐ž๐ฆ๐ž๐ง๐ญ๐ฌ ๐š๐›๐จ๐ฎ๐ญ ๐‚๐ž๐ซ๐ญ๐š๐ข๐ง ๐‚๐Ž๐•๐ˆ๐ƒ-๐Ÿ๐Ÿ— ๐€๐ง๐ญ๐ข๐ ๐ž๐ง ๐‘๐š๐ฉ๐ข๐ ๐’๐ž๐ฅ๐Ÿ-๐“๐ž๐ฌ๐ญ ๐Š๐ข๐ญ๐ฌ

The Health Sciences Authority (HSA) has received several enquiries on the recent antigen rapid self-test kit announcements by the United States Food and Drug Administration (US FDA).

In Singapore, only COVID-19 antigen rapid self-test kits that have been authorised by HSA under the Pandemic Special Access Route (PSAR) or full registration can be supplied. HSA has evaluated these test kits to meet the required safety, quality and efficacy standards before granting PSAR authorisation or full registration.

Advertisements

There can be several versions of antigen rapid self-test kits supplied under the same manufacturerโ€™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 FDAโ€™s announcements are not related to any specific quality, safety or accuracy issues.

Singaporeโ€™s supplies of test kits under these 2 brands are not impacted by the US FDAโ€™s advisory.

Consumers are advised to purchase their antigen rapid self-test  kits from reputable local retailers and pharmacies. The full list of COVID-19 self-test kits HSA has authorised for use in Singapore can be found at https://www.hsa.gov.sg/…/arti…/details/covid19_selftests

- Advertisement -
- Advertisement -
Latest News

PRITAM SINGH “STORMS OFF” DURING MP’S SPEECH, BUT THINGS ARE NOT WHAT IT SEEMS

A video emerged online by TikTok page @gongsimisg, showing WP boss and Leader of the Opposition Pritam Singh appearing...
- Advertisement -