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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 2.0E
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™ SARS-CoV-2 IgM/IgG Rapid Test
9  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 (Lateral Flow Method)
 SkyQuest_Wondfo_Provisional Authorisation for Covid-19 tests_17072020135 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 Diagnostics Development Hub (DxD)
 Fortitude™ Kit 2.1
 DXD_Provisional Authorisation for Covid-19 tests_05052020444 KB
30 Abbott Laboratories (S) Pte Ltd
 Abbott SARS-CoV-2 IgG – ARCHITECT assay
 Abbott_Provisional Authorisation for Covid-19 tests_05052020444 KB
31 Genomax Technologies Pte Ltd
 Allplex 2019-nCoV Assay
 Genomax_Provisional Authorisation for Covid-19 tests_05052020446 KB
32 BioWalker Pte Ltd
 BioWalker SARS-CoV-2 Assay 2.0
 Biowalker_Provisional Authorisation for Covid-19 tests_05052020441 KB
33 Tanglin Cardiology Pte Ltd
 Liferiver Novel Coronavirus (2019-nCoV) Real Time Multiplex RT-PCR Kit
 Tanglin_Provisional Authorisation for Covid-19 tests_05052020451 KB
34  Roche Diagnostics Asia Pacific Pte Ltd
 Roche Elecsys Anti-SARS-CoV-2
 Roche_Provisional Authorisation for Covid-19 tests_05052020443 KB
35  Becton Dickinson Holding Ptd Ltd
 BD SARS-CoV-2 Reagents for BD MAX™ System
 Becton Dickinson_Provisional Authorisation for Covid-19 tests__06052020450 KB
36 Biomed Diagnostics Pte Ltd
 Liferiver Novel Coronavirus (2019-nCoV) Real Time Multiplex RT-PCR Kit  Biomed_Provisional Authorisation for Covid-19 tests_06052020455 KB
37 Ortho Clinical Diagnostics
 VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack
 Ortho Clinical Diagnostics_Provisional Authorisation for Covid-19 tests_15052020455 KB
38 MP Biomedicals Asia Pacific Pte Ltd
 MP Diagnostics ASSURE® SARS-CoV-2 IgG/IgM Rapid Test
 MP Biomedicals_Provisional Authorisation for Covid-19 tests_09072020134 KB
39 Biomed Diagnostics Pte Ltd
 INNOVITA 2019-nCoV Ab Test (Colloidal Gold)
 Biomed_Innovita_Provisional Authorisation for Covid-19 tests_12052020450 KB
40 Biomed Diagnostics Pte Ltd
 Luminex NxTAG® CoV Extended Panel Assay
 Biomed_Luminex_Provisional Authorisation for Covid-19 tests_12052020443 KB
41 Genscript Biotech (Singapore) Pte Ltd
 SARS-CoV-2 Neutralization Antibody Detection Kit
 Genscript_Provisional Authorisation for Covid-19 tests_12052020447 KB
42 MiRXES Pte Ltd
 MiRXES Fortitude Kit 2.1
 MiRXES_Fortitude 2.1_Provisional Authorisation for Covid-19 tests_12052020440 KB
43 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
44 BioMérieux Singapore Pte Ltd
 BioFire® Respiratory Panel 2.1 (RP2.1)
 BioMérieux_Provisional Authorisation for Covid-19 tests_15052020442 KB
45 SPD Scientific Pte Ltd
 GeneFinder™ COVID-19 Plus RealAmp Kit
 SPD_GeneFinder_Provisional Authorisation for Covid-19 tests_15052020449 KB
46 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
47 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
48 SDT Molecular Pte Ltd
 altona Diagnostics RealStar™ SARS-CoV-2 RT-PCR Kit 1.0
 SDT_Provisional Authorisation for Covid-19 tests_19052020445 KB
49 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
50 AMT Pte Ltd
 AMT RESOLUTE 1.0
 AMT_Provisional Authorisation for Covid-19 tests_22052020433 KB
51 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
52 Ying Assets Management Pte Ltd
 INNOVITA 2019-nCoV Ab Test (Colloidal Gold)
 Ying Assets_Provisional Authorisation for Covid-19 tests_22052020443 KB
53 Abbott Laboratories (S) Pte Ltd
 ABBOTT Alinity i SARS-CoV-2 IgG
 Abbott_Alinity_Provisional Authorisation for Covid-19 tests_28052020127 KB
54 Novena Global Healthcare Pte Ltd
 Fosun Novel Coronavirus (2019-nCoV) RT-PCR Detection Kit
 Novena_Fosun_Provisional Authorisation for Covid-19 tests_28052020131 KB
55 COBS Pte Ltd
 BIOSYNEX COVID-19 BSS
 COBS_BIOSYNEX_Provisional Authorisation for Covid-19 tests_28052020127 KB
56 Siemens Healthcare Pte Ltd
 FTD™ SARS-CoV-2
 Siemens_FTD_Provisional Authorisation for Covid-19 tests_28052020131 KB
57 Qiagen Singapore Pte. Ltd 
 QIAstat-Dx® Respiratory SARS-CoV-2 Panel
 Qiagen_QIAstat_Provisional Authorisation for Covid-19 tests_02062020137 KB
58 Euroimmun (South East Asia) Pte. Ltd.
 EUROIMMUN Anti-SARS-CoV-2 ELISA (IgG)
 Euroimmun_Anti-SARS IgG_Provisional Authorisation for Covid-19 tests_02062020127 KB
59 SPD Scientific Pte Ltd
 2019-nCoV IgG/IgM Rapid Test
 SPD Scientific_2019-nCoV_Provisional Authorisation for Covid-19 tests_02062020133 KB
60 Trident Pharm Pte Ltd
 SARS-CoV-2 Antibody Test Strip
 Trident_SARS-CoV-2_Provisional Authorisation for Covid-19 tests_02062020124 KB
61 Sinch Medical Pte Ltd
 2019-nCOV/COVID-19 IgG/IgM Rapid Test Device
 Sinch_2019-nCov_Provisional Authorisation for Covid-19 tests_02062020133 KB
62 Euroimmun (South East Asia) Pte. Ltd.
 EUROIMMUN Anti-SARS-CoV-2 ELISA (IgA)
 Euroimmun_Anti-SARS IgA_Provisional Authorisation for Covid-19 tests_02062020126 KB
63 Transmedic Pte Ltd
 Genrui Novel Coronavirus (2019-nCoV) IgG/IgM Test Kit (Colloidal Gold)
 Transmedic_Genrui_Provisional Authorisation for Covid-19 tests_12062020132 KB
64 Siemens Healthcare Pte Ltd
 Siemens Atellica® IM SARS-CoV-2 Total (COV2T)
 Siemens_Atellica_Provisional Authorisation for Covid-19 tests_02062020129 KB
65 Siemens Healthcare Pte Ltd
 Siemens ADVIA Centaur® SARS-CoV-2 Total (COV2T)
 Siemens_ADVIA_Provisional Authorisation for Covid-19 tests_02062020129 KB
66 Xentific Labs Pte Ltd
 Standard Q COVID-19 Ag Test
 Xentific_Standard Q_Provisional Authorisation for Covid-19 tests_08062020135 KB
67 Veredus Laboratories Pte Ltd
 VereRTCoV™ SARS-CoV-2 Real-Time RT-PCR 2.0
 Veredus_VereRTCoV_Provisional Authorisation for Covid-19 tests_08062020129 KB
68 Ortho Clinical Diagnostics
 VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack
 Ortho Clinical_VITROS_Provisional Authorisation for Covid-19 tests_08062020143 KB
69 Alcotech Pte Ltd
 2019-nCoV IgG/IgM Rapid Test Cassette
 Alcotech_2019-nCoV_Provisional Authorisation for Covid-19 tests_08062020131 KB
70 Unison Collaborative Pte Ltd
 RightSign COVID-19 IgG/IgM Rapid Test Cassette
 Unison_RightSign_Provisional Authorisation for Covid-19 tests_12062020131 KB
71 XIN Pte Ltd
 Fosun Novel Coronavirus (2019-nCoV) RT-PCR Detection Kit
 Xin_Fosun_Provisional Authorisation for Covid-19 tests_19062020130 KB
72 Credo Diagnostics Biomedical Pte Ltd
 VitaPCR™ SARS-CoV-2 Gen 2 Assay  Credo_VitaPCR_Provisional Authorisation for Covid-19 tests_19062020132 KB
73  Biomed Diagnostics Pte Ltd
 Luminex ARIES® SARS-CoV-2 Assay
 Biomed_Luminex Aries_Provisional Authorisation for Covid-19 tests_19062020132 KB
74 TODOS MEDICAL SINGAPORE Pte Ltd
 Kaira 2019-nCoV Detection Kit
 TODOS_Kaira_Provisional Authorisation for Covid-19 tests_25062020129 KB
75 Bio-Rad Laboratories (Singapore) Pte Ltd
 Biorad Platelia SARS-CoV-2 Total Ab
 Biorad_Platelia_Provisional Authorisation for Covid-19 tests_25062020128 KB 
76 All Eights (Singapore) Pte Ltd
 Hologic Aptima® SARS-CoV-2 assay
 All Eights_Hologic_Provisional Authorisation for Covid-19 tests_25062020128 KB
77 Beckman Coulter Singapore Pte Ltd
 ACCESS SARS-CoV-2 IgG
 Beckman Coulter_Access_Provisional Authorisation for Covid-19 tests_03072020128 KB
78 Accelerate Technologies Pte Ltd (DxD Hub)
 Accelerate Technologies Resolute 2.0 assay
 Accelerate Technologies_Resolute_Provisional Authorisation for Covid-19 tests_25062020133 KB
79 ZMC Technologies (Singapore) Pte Ltd

 

Novel Coronavirus (2019-nCoV) IgG/IgM Antibody Test Kit (Colloidal Gold)

 ZMC_nCoV_Provisional Authorisation for Covid-19 tests updated_09072020136 KB
80 Unison Collaborative Pte Ltd
 Panbio™ COVID-19 IgG/IgM Rapid Test Device
 Unison_Panbio_Provisional Authorisation for Covid-19 tests_25062020137 KB
81 All Eights (Singapore) Pte Ltd
 genesig® Real-Time PCR Coronavirus COVID-19
 All Eights_genesig_Provisional Authorisation for Covid-19 tests_25062020132 KB
82 Andaman Medical Pte Ltd
 Seegene Allplex™ SARS-CoV-2 Assay
 Andaman_Seegene_Provisional Authorisation for Covid-19 tests_25062020128 KB
83 RAS Pharma and Biochem Pte Ltd
 RAS Rapid Test - 2019-nCov IgG/IgM Rapid Test
 RAS Pharma_RAS Rapid_Provisional Authorisation for Covid-19 tests_25062020133 KB
84 Cell ID Pte Ltd
 Smart COVID-19 IgM-IgG Rapid Diagnostic Test
 Cell ID_Smart_Provisional Authorisation for Covid-19 tests_03072020132 KB
85 DSO National Laboratories
 RESOLUTE 1.0 LITE
 DSO_Resolute 1.0 LITE_Provisional Authorisation for Covid-19 tests_03072020129 KB
86 Restalyst Pte Ltd
 RAPIT COVID-19 IgM/IgG Test Kit
 Restalyst_Rapit_Provisional Authorisation for Covid-19 tests_03072020131 KB
87 EMERGO by UL 
 AccuraDTect SARS-CoV-2 RT-qPCR Kit
 Emergo_AccuraDTect_Provisional Authorisation for Covid-19 tests_03072020128 KB
88 Vela Operations Singapore Pte Ltd
 ViroKey™ SARS-CoV-2 RT-PCR Test v2.0
 Vela_ViroKey_Provisional Authorisation for Covid-19 tests_03072020130 KB
89 Biotrilance Pte Ltd
 Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Kit (PCR-Fluorescence Probing)
 Biotrilance_Novel_Provisional Authorisation for Covid-19 tests_09072020134 KB
90 Genomax Technologies Pte Ltd
 Hangzhou Lysun 2019-nCoV IgG/IgM Rapid Test Device
 Genomax_Hangzhou Lysun_Provisional Authorisation for Covid-19 tests_09072020133 KB
91 JN Medsys Pte Ltd
 ProTect COVID-19 RT-qPCR Kit 2.0
 JN Medsys_ProTect_Provisional Authorisation for Covid-19 tests_09072020129 KB
92 AMT Pte Ltd
 AMT Resolute 2.0 assay
 AMT_Resolute 2.0_Provisional Authorisation for Covid-19 tests_09072020125 KB
93 Alcotech Pte Ltd
 FaStep COVID-19 Antigen Rapid Test Device (Nasopharyngeal/ Oropharyngeal Swab)
 Alcotech_FaStep_Provisional Authorisation for Covid-19 tests_09072020132 KB
94 Siemens Healthcare Pte Ltd
 Siemens Atellica® IM SARS-CoV-2 IgG (COV2G)
 Siemens_Atellica_Provisional Authorisation for Covid-19 tests_17072020132 KB
95 Siemens Healthcare Pte Ltd
 Siemens ADVIA Centaur® SARS-CoV-2 IgG (COV2G)
 Siemens_ADVIA Centaur_Provisional Authorisation for Covid-19 tests_17072020132 KB
96 Hi-Beau Group
 SAVANT™ New Coronavirus (SARS-CoV-2) N Protein Detection Kit (Fluorescence Immunochromatography)
 Hi-Beau Group_SAVANT_Provisional Authorisation for Covid-19 tests_17072020138 KB
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