HSA Expedites Approval of COVID-19 Diagnostic Tests in Singapore via Provisional Authorisation

The Health Sciences Authority (HSA) is committed to ensuring the rapid availability of diagnostic tests for COVID-19 in Singapore. Since 29 January 2020, HSA has been closely providing regulatory and scientific advice to research institutions as well as local and multi-national companies to ensure the timely availability of good quality performing test kits that are critical during this period of need.

See Table below for more information on the diagnostic tests that we have approved to date via provisional authorisation.

Provisional authorisation

To address the urgent need for timely detection of COVID-19 infection, HSA has set up a provisional authorisation process for tests intended for the detection and/or diagnosis of COVID-19 infection. This has helped expand the number and variety of diagnostic tests available in Singapore.

This provisional authorisation is based on a risk-calibrated review process that considers the design aspects of the test (e.g. primers and probe design, target sequence in the viral RNA) and the supporting validation data122 KB (e.g. Limit of detection, cross reactivity, inclusivity). Periodic reports on specific data on the safety and/or performance of these tests will be required to be submitted to HSA post authorisation to assure the continued performance of these devices. If any safety or performance issues are observed, HSA will require relevant follow up actions at the manufacturer’s end. 

This provisional authorisation has been implemented as an interim measure in response to the current public health need for timely detection of COVID-19 infections. If an applicant wishes to supply this test in the long  term, it must be registered with HSA. You can find more information on product registration here.

If you have any questions regarding this provisional authorisation process, please contact us here.

How to submit an application for Provisional Authorisation to HSA:

Email hsa_md_info@hsa.gov.sg with the subject ‘Provisional Authorisation’ with the following information:

  • A brief description of your test (test design, target biomarker, device technology, description of key functional elements, specifications, composition, accessories)
  • Intended purpose of your test
  • Information for Users (IFU) for the test
  • Summary of analytical validation (e.g. Limit of Detection, inclusivity, cross-reactivity, precision, interfering substances, Hook effect) and clinical data collected for your test where available
  • Summary of any planned or ongoing validation including clinical studies

HSA will get in touch with the applicant within 3 working days.

 

The Table below lists the COVID-19 tests that have received provisional authorisation to date. It will be updated as more tests gets approved: 

No.

Applicant

Name of test

For more information

1

Diagnostics Development Hub (DxD)

 

FORTITUDE KIT 2.0

2

Veredus Laboratories Pte Ltd

 

VereCoV™ Detection Kit

3

AITbiotech Pte Ltd

 

abTES™ COVID-19 qPCR I Kit

4

DSO National Laboratories

Real-Time PCR Assay for the Detection of SARS-CoV-2 Virus

5

Roche Diagnostics Asia Pacific Pte Ltd

Cobas® SARS-CoV-2

Roche_Provisional Authorisation for Covid-19 tests_17042020448 KB
6

JN Medsys Pte Ltd

ProTect™ COVID-19 RT-qPCR Kit

7

Life Technologies Holdings Pte Ltd

TaqPath™ COVID-19 Combo Kit

8

Everest Links Pte Ltd

VivaDiag™ COVID-19 IgM/IgG Rapid Test

Biolidics Limited              

Nanjing Vazyme 2019-nCoV IgG/IgM Detection Kit

also marketed as

Biolidics 2019-nCoV IgG/IgM Detection Kit

Biolidics Limited451 KB
10 Biowalker Pte Ltd Kit for Novel-Coronavirus (2019-nCoV) RNA (Isothermal Amplification-Real Time Fluorescence Assay)
Biowalker Pte Ltd453 KB
11 SPD Scientific Pte Ltd  Cepheid® Xpert® Xpress SARS-CoV-2  SPD Scientific Pte Ltd446 KB
12 MiRXES Pte Ltd MiRXES FORTITUDE KIT 2.0
MiRXES_Provisional Authorisation for Covid-19 tests_17042020439 KB
13 Acumen Research Laboratories
Acu-Corona™ 2.0  Acumen Research Laboratories Pte Ltd442 KB
14 Credo Diagnostics Biomedical Pte Ltd
VitaPCR™ SARS-CoV-2 Assay
Credo Diagnostics Biomedical Pte Ltd443 KB
15 Abbott Laboratories (Singapore) Pte Ltd
Abbott RealTime SARS-CoV-2 assay
Abbott Laboratories (Singapore) Pte Ltd445 KB
16 All Eights (Singapore) Pte Ltd
Seegene AllplexTM 2019-nCoV Assay
All Eights (Singapore) Pte Ltd444 KB
17 SkyQuest Pte Ltd
Wondfo SARS-CoV-2 Antibody Test
SkyQuest Pte Ltd449 KB
18 Camtech Diagnostics Pte Ltd
Camtech COVID-19 IgM/IgG
Camtech Diagnostics Pte Ltd442 KB
19 Acumen Research Laboratories Pte Ltd
Acu-Corona 3.0
Acumen Research Laboratories Pte Ltd - Acu-Corona 3.0444 KB
20 Vela Operations Singapore Pte Ltd
ViroKey SARS-CoV-2 RT-PCR Test  Vela_Provisional Authorisation for Covid-19 tests_17042020441 KB
21 PerkinElmer Singapore Pte Ltd               PerkinElmer® SARS-CoV-2 Real-time RT-PCR Assay
PerkinElmer_Provisional Authorisation for Covid-19 tests_24042020438 KB
22 BioWalker Pte Ltd
BioWalker SARS-CoV-2 Assay
Biowalker_Provisional Authorisation for Covid-19 tests_24042020438 KB
23 Medicell Pharmaceutical (S) Pte Ltd
Sansure Biotech Novel Coronavirus(2019-nCoV) Nucleic Acid Diagnostic Kit
Medicell_Provisional Authorisation for Covid-19 tests_24042020448 KB
24  Grit Overseas Pte Ltd  DiagnoSure COVID-19 IgG/ IgM Rapid Test Cassette
Grit_Provisional Authorisation for Covid-19 tests_24042020445 KB
25 BGI Health (SG) Company Pte Ltd
Real-time fluorescent RT-PCR kit for detecting 2019-nCoV
BGI_Provisional Authorisation for Covid-19 tests_12052020457 KB
26 Veredus Laboratories Pte Ltd
Shanghai LiangRun LionRun Diagnostic Kit for Antibody IgM-IgG of Novel Coronavirus COVID-19  Veredus_Provisional Authorisation for Covid-19 tests_05052020454 KB
27 Bioforge Solutions Pte Ltd
INNOVITA 2019-nCoV Ab Test (Colloidal Gold)
Bioforge_INNOVITA_Provisional Authorisation for Covid-19 tests_05052020451 KB
28 Bioforge Solutions Pte Ltd
Wondfo SARS-CoV-2 Antibody Test (Lateral Flow Method)
Bioforge_Wondfo_Provisional Authorisation for Covid-19 tests_05052020447 KB
29 Grey Solutions Pte Ltd
i-Test COVID -19 IgM/IgG Antibody Rapid Test (Colloidal Gold)
Grey_Provisional Authorisation for Covid-19 tests_05052020448 KB
30 Diagnostics Development Hub (DxD)
Fortitude™ Kit 2.1
DXD_Provisional Authorisation for Covid-19 tests_05052020444 KB
31 Abbott Laboratories (S) Pte Ltd
Abbott SARS-CoV-2 IgG – ARCHITECT assay
Abbott_Provisional Authorisation for Covid-19 tests_05052020444 KB
32 Genomax Technologies Pte Ltd
Allplex 2019-nCoV Assay
Genomax_Provisional Authorisation for Covid-19 tests_05052020446 KB
33 BioWalker Pte Ltd
BioWalker SARS-CoV-2 Assay 2.0
Biowalker_Provisional Authorisation for Covid-19 tests_05052020441 KB
34 Tanglin Cardiology Pte Ltd
Liferiver Novel Coronavirus (2019-nCoV) Real Time Multiplex RT-PCR Kit
Tanglin_Provisional Authorisation for Covid-19 tests_05052020451 KB
35  Roche Diagnostics Asia Pacific Pte Ltd
Roche Elecsys Anti-SARS-CoV-2
Roche_Provisional Authorisation for Covid-19 tests_05052020443 KB
36  Becton Dickinson Holding Ptd Ltd
BD SARS-CoV-2 Reagents for BD MAX™ System
Becton Dickinson_Provisional Authorisation for Covid-19 tests__06052020450 KB
37 Biomed Diagnostics Pte Ltd
Liferiver Novel Coronavirus (2019-nCoV) Real Time Multiplex RT-PCR Kit  Biomed_Provisional Authorisation for Covid-19 tests_06052020455 KB
38 Ortho Clinical Diagnostics
VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack
Ortho Clinical Diagnostics_Provisional Authorisation for Covid-19 tests_15052020455 KB
39 MP Biomedicals Asia Pacific Pte Ltd
MP Diagnostics ASSURE® SARS-CoV-2 IgG/IgM Rapid Test
MP Biomedicals_Provisional Authorisation for Covid-19 tests_12052020448 KB 
40 Biomed Diagnostics Pte Ltd
INNOVITA 2019-nCoV Ab Test (Colloidal Gold)
Biomed_Innovita_Provisional Authorisation for Covid-19 tests_12052020450 KB
41 Biomed Diagnostics Pte Ltd
Luminex NxTAG® CoV Extended Panel Assay
Biomed_Luminex_Provisional Authorisation for Covid-19 tests_12052020443 KB
42 Genscript Biotech (Singapore) Pte Ltd
SARS-CoV-2 Neutralization Antibody Detection Kit
Genscript_Provisional Authorisation for Covid-19 tests_12052020447 KB
43 MiRXES Pte Ltd
MiRXES Fortitude Kit 2.1
MiRXES_Fortitude 2.1_Provisional Authorisation for Covid-19 tests_12052020440 KB
44 Trans Sahara Corporation Pte Ltd
Xiamen Boson Rapid 2019-nCOV IgG/IgM Combo Test Card
Trans Sahara_Provisional Authorisation for Covid-19 tests_15052020448 KB
45 BioMérieux Singapore Pte Ltd
BioFire® Respiratory Panel 2.1 (RP2.1)
BioMérieux_Provisional Authorisation for Covid-19 tests_15052020442 KB
46 SPD Scientific Pte Ltd
GeneFinder™ COVID-19 Plus RealAmp Kit
SPD_GeneFinder_Provisional Authorisation for Covid-19 tests_15052020449 KB
47 All Eights (Singapore) Pte Ltd
EDI™ Novel Coronavirus COVID-19 IgG ELISA Kit
All Eights_EDI IgG_Provisional Authorisation for Covid-19 tests_19052020446 KB
48 All Eights (Singapore) Pte Ltd
EDI™ Novel Coronavirus COVID-19 IgM ELISA Kit
All Eights_EDI IgM_Provisional Authorisation for Covid-19 tests_19052020445 KB
49 SDT Molecular Pte Ltd
altona Diagnostics RealStar™ SARS-CoV-2 RT-PCR Kit 1.0
SDT_Provisional Authorisation for Covid-19 tests_19052020445 KB
50 Healthgroup Medical Pte Ltd
HealthGroup Medical V-CODE Sars-CoV-2 (COVID-19) IgG/IgM Rapid Test
Healthgroup_Provisional Authorisation for Covid-19 tests_19052020446 KB
51 AMT Pte Ltd
AMT RESOLUTE 1.0
AMT_Provisional Authorisation for Covid-19 tests_22052020433 KB
52 I-Test Pte Ltd
i-Test COVID -19 IgM/IgG Antibody Rapid Test (Colloidal Gold)
I-Test_Provisional Authorisation for Covid-19 tests_22052020442 KB
53 Ying Assets Management Pte Ltd
INNOVITA 2019-nCoV Ab Test (Colloidal Gold)
Ying Assets_Provisional Authorisation for Covid-19 tests_22052020443 KB
54 Abbott Laboratories (S) Pte Ltd
ABBOTT Alinity i SARS-CoV-2 IgG
Abbott_Alinity_Provisional Authorisation for Covid-19 tests_28052020127 KB
55 Novena Global Healthcare Pte Ltd
Fosun Novel Coronavirus (2019-nCoV) RT-PCR Detection Kit
Novena_Fosun_Provisional Authorisation for Covid-19 tests_28052020131 KB
56 COBS Pte Ltd
BIOSYNEX COVID-19 BSS
COBS_BIOSYNEX_Provisional Authorisation for Covid-19 tests_28052020127 KB
57 Siemens Healthcare Pte Ltd
FTD™ SARS-CoV-2
Siemens_FTD_Provisional Authorisation for Covid-19 tests_28052020131 KB
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