COVID-19 antigen rapid tests (ART) self-test kits authorised for use in Singapore

Consumer, Healthcare professional, Industry member, Medical devices, Medical devices
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The Health Sciences Authority (HSA) is committed to ensuring the availability of COVID-19 antigen rapid test (ART) self-test kits that meet the required safety, efficacy and quality standards, for individuals to administer on their own. Only ARTs that the Ministry of Health (MOH) has determined to have a clinical need will qualify for HSA’s evaluation under the Pandemic Special Access Route (PSAR). HSA will then evaluate the ARTs based on accrued data from the companies to determine if they meet the appropriate standards of safety, quality and efficacy, before granting PSAR authorisation.

To ensure the continued good performance of these tests after PSAR authorisation, companies are required to collect the relevant accuracy and safety data and monitor the use of the tests. HSA will also require additional data from ongoing clinical studies to be submitted post-approval for HSA to ensure the continued safety and efficacy of these PSAR-authorised tests. If any safety or performance issues are observed, HSA will require the company to take the relevant follow-up actions.

Consumers are advised to only purchase and use tests that have been authorised by HSA. As these tests are meant to be used by consumers, no doctor’s prescription is required for their purchase. These tests will be widely available through designated local retail pharmacies from 16 June 2021 and will be made available at more retail locations progressively. Consumers can refer to MOH’s guidelines on COVID-19 self-testing to ensure the correct use and appropriate follow-up actions based on the results of the self-testing. 

The following ARTs have been authorised by HSA under PSAR:

This list is updated as at 12 August 2021.

Name of antigen rapid self-test

Name of distributor

Authorisation date

Abbott PanBioTM COVID-19 Antigen Self-Test

Unison Collaborative Pte Ltd

31 May 2021

Quidel QuickVue At-Home OTC COVID-19 Test

Quantum Technologies Global Pte Ltd

2 June 2021

SD Biosensor SARS-CoV-2 Antigen Self-Test Nasal

Roche Diagnostics Asia Pacific Pte Ltd

9 June 2021

SD Biosensor Standard Q COVID-19 Ag Home Test

SPD Scientific Pte Ltd

9 June 2021

BD Veritor At-Home COVID-19 Test Becton Dickinson Holdings Pte Ltd
15 June 2021
BD Kit for Rapid Detection of SARS-CoV-2
Becton Dickinson Holdings Pte Ltd
12 August 2021

 

 

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