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COVID-19 Test Kits Authorised for Professional Use

With effect from 1 January 2022, only COVID-19 tests that have received full-fledged registration with HSA or have been authorised under the Pandemic Special Access Route (PSAR) shall be supplied in Singapore.

The COVID-19 tests that have received full-fledged registration with HSA are listed on the Singapore Medical Device Register (SMDR). This register can be accessed online here.

Where there are tests that have not been registered on SMDR as yet, and the Ministry of Health (MOH) determines that there is a clinical need for the use of these tests, MOH designates these tests as “emergency medical devices”. Only these tests would qualify for authorisation under the PSAR. HSA evaluates to determine if these tests meet the essential standards of safety, quality, and efficacy as appropriate prior to granting authorisation under PSAR.

The following COVID-19 diagnostic tests have been authorised for Professional Use by HSA under PSAR. These tests shall only be supplied to healthcare institutions, private hospitals, medical clinics, or clinical laboratories licensed under the PHMC Act (Cap. 248) for use on their patients.

Molecular Tests 

No

Name of PUO test

Name of distributor

Authorisation date

SDT Molecular Pte Ltd

16/11/2021

2

Veredus VereCoV™ OneMix Detection Kit2665 KB

Veredus Laboratories Pte. Ltd.

16/11/2021

3

PerkinElmer® SARS-CoV-2 Real-time RT-PCR Assay1627 KB

PerkinElmer Singapore Pte Ltd

30/11/2021

4

JN Medsys ProTect™ COVID-19 RT-qPCR kit 2.02101 KB

JN Medsys

30/11/2021

5

BioFire® Respiratory Panel 2.1 (RP2.1)1290 KB

bioMérieux Singapore Pte Ltd

30/11/2021

6

BioFire® Respiratory Panel 2.1 plus (RP2.1 plus)1337 KB

bioMérieux Singapore Pte Ltd

30/11/2021

7

Cepheid Xpert® Xpress SARS-CoV-21485 KB

SPD Scientific Pte Ltd

30/11/2021

8

Abbott Alinity m SARS-CoV-2 AMP Kit1188 KB

Abbott Laboratories (Singapore) Pte. Ltd

30/11/2021

9

Veredus VereRT™ COVID-19 PCR Kit865 KB

Veredus Laboratories Pte. Ltd.

30/11/2021

10 MiRXES Fortitude Kit 2.11331 KB
MiRXES Pte Ltd
8/12/2021
11 MiRXES Fortitude Kit 3.03452 KB
MiRXES Pte Ltd
8/12/2021
12 Hologic Aptima SARS-CoV-2 Assay488 KB
All Eights (S) Pte Ltd
9/12/2021
13 Life Technologies TaqPath COVID-19 Combo Kit626 KB
Life Technologies Holdings Pte. Ltd.
16/12/2021
14 Acumen Acu-Corona Duplex1256 KB
Acumen Research Laboratories Pte Ltd
16/12/2021
15 Acumen Acu-Corona 2.01541 KB
Acumen Research Laboratories Pte Ltd
27/12/2021
16 QIAGEN QIAstat-Dx Respiratory SARS-CoV-2 Panel1419 KB
Qiagen Singapore Pte. Ltd.
31/12/2021

 

 

Antigen Tests

No

Name of PUO test

Name of distributor

Authorisation date

1

BD Veritor™ System for Rapid Detection of SARS-CoV- 2 (256082, 256089)1105 KB
Becton Dickinson Holding Ptd Ltd 9/12/2021

2

BD Kit for Rapid Detection of SARS-CoV-2 (256091, 256113, 256114)4556 KB Becton Dickinson Holding Ptd Ltd 9/12/2021

3

SD Biosensor Standard Q COVID-19 Ag3008 KB SPD Scientific Pte Ltd 31/12/2021
4 PHASE Scientific INDICAID® COVID-19 Rapid Antigen Test396 KB
SDT Molecular Pte Ltd
24/01/2022
Transfingo Aviation Solutions Pte Ltd
23/02/2022
PDS International Pte Ltd
4/04/2022
Alliance Pharma Pte Ltd 15/07/2022
5
Abbott Panbio™ COVID-19 Ag Rapid Test Device (Nasal)5924 KB
Abbott Diagnostics Pte Ltd
25/04/2022
6 Abbott Panbio™ COVID-19 Ag Rapid Test Device (Nasopharyngeal)5825 KB
Abbott Diagnostics Pte Ltd
25/04/2022
DCH Auriga
26/05/2022

 

 

Antibody (Serology) Tests

No

Name of PUO test

Name of distributor

Authorisation date

1

GENSCRIPT cPass™ SARS-CoV-2 Neutralization Antibody Detection Kit1005 KB Genscript Biotech (Singapore) Pte. Ltd.

30/11/2021

 

2

bioMérieux VIDAS® SARS-COV-2 IgM312 KB bioMérieux Singapore Pte Ltd

24/12/2021

 

3

Abbott Alinity i SARS-CoV-2 IgM1281 KB Abbott Laboratories (Singapore) Pte Ltd 29/12/2021

4

Restalyst COVID19N-REAAD™ Anti-SARS-CoV-2 Nucleocapsid Protein IgG ELISA460 KB Restalyst Pte Ltd 29/12/2021

5

Beckman Coulter Access SARS-CoV-2 IgG291 KB Beckman Coulter Singapore Pte Ltd 31/12/2021

6

 
Beckman Coulter Access SARS-CoV-2 IgM292 KB
Beckman Coulter Singapore Pte Ltd 31/12/2021
7 Boditech AFIAS COVID-19 Ab508 KB
All Eights (Singapore) Pte Ltd
15/08/2022

 

 

Other Tests

No

Name of PUO test

Name of distributor

Authorisation date

 

 
 

 

For COVID-19 diagnostic tests authorised under PSAR, distributors should prepare to transition to full registration for their tests.

Full Registration Requirements for COVID-19 Tests

For registration submission requirements, please refer to the below guidance documents which can be found here:

  • GN-18 Guidance on Preparation of a Product Registration Submission for In Vitro Diagnostic (IVD) Medical Devices using the ASEAN CSDT” under header Product Registration
  • TR-02 Contents of a Product Registration Submission for In-Vitro Diagnostic Medical Devices using the ASEAN CSDT” under header Technical Reference Documents

The above guidance documents include requirements applicable for all clinical diagnostic tests based on different technologies. Therefore, for each diagnostic test depending on the methodology and intended purpose of the test, the manufacturer should validate their test for the relevant parameters described in the documents that are relevant to their test.

In addition, some of the key validation requirements applicable for full registration of Professional Use COVID-19 tests are summarised in the pdf file below:

Validation Requirements for Product Registration of COVID-19 Diagnostic Tests - Professional Use Only.pdf224 KB

Healthcare professional, Industry member, Medical devices
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