Effective January 1, 2022, only HSA-registered or PSAR authorized COVID – 19 test kits will be listed on the Singapore Medical Device Register (SMDR) and are allowed for supply in Singapore. For test kits that are not yet registered but are clinically needed, the Ministry of Health (MoH) categorizes these as “emergency medical devices and Professional Use Only (PUO) kits. PUO products will need further evaluation from HSA.
The following PUO test kits are HSA-authorized under the PSAR. They will be supplied to healthcare institutions, private hospitals, medical clinics, or clinical laboratories that are licensed under the Private Hospitals and Medical Clinics (PHMC) Act:
Molecular Tests
|
PUO Test |
Distributor |
Authorization Date |
|
Altona Diagnostics RealStar SARS-CoV-2 RT-PCR Kit 1.0515 KB |
SDT Molecular Pte Ltd |
16/11/2021 |
|
Veredus VereCoV™ OneMix Detection Kit2665 KB |
Veredus Laboratories Pte. Ltd. |
16/11/2021 |
|
PerkinElmer® SARS-CoV-2 Real-time RT-PCR Assay1301 KB |
PerkinElmer Singapore Pte Ltd |
30/11/2021 |
|
JN Medsys ProTect™ COVID-19 RT-qPCR kit 2.02101 KB |
JN Medsys |
30/11/2021 |
|
BioFire® Respiratory Panel 2.1 (RP2.1)1290 KB |
bioMérieux Singapore Pte Ltd |
30/11/2021 |
|
BioFire® Respiratory Panel 2.1 plus (RP2.1 plus)1337 KB |
bioMérieux Singapore Pte Ltd |
30/11/2021 |
|
Cepheid Xpert® Xpress SARS-CoV-21485 KB |
SPD Scientific Pte Ltd |
30/11/2021 |
| Abbott Alinity m SARS-CoV-2 AMP Kit1188 KB | Abbott Laboratories (Singapore) Pte. Ltd | 30/11/2021 |
| Veredus VereRT™ COVID-19 PCR Kit865 KB | Veredus Laboratories Pte. Ltd. | 30/11/2021 |
| MiRXES Fortitude Kit 2.11339 KB | MiRXES Pte Ltd | 8/12/2021 |
| MiRXES Fortitude Kit 3.02722 KB | MiRXES Pte Ltd | 8/12/2021 |
| Hologic Aptima SARS-CoV-2 Assay488 KB | All Eights (S) Pte Ltd | 9/12/2021 |
| Life Technologies TaqPath COVID-19 Combo Kit626 KB | Life Technologies Holdings Pte. Ltd. | 16/12/2021 |
| Acumen Acu-Corona Duplex1256 KB | Acumen Research Laboratories Pte Ltd | 16/12/2021 |
| Acumen Acu-Corona 2.01541 KB | Acumen Research Laboratories Pte Ltd | 27/12/2021 |
| QIAGEN QIAstat-Dx Respiratory SARS-CoV-2 Panel1419 KB | Qiagen Singapore Pte. Ltd. | 31/12/2021 |
Antigen Tests
|
PUO Test |
Distributor |
Authorization Date |
|
Roche Diagnostics Elecsys SARS-CoV-2 Antigen251 KB |
Roche Diagnostics Asia Pacific Pte Ltd |
30/11/2021 |
|
BD Veritor™ System for Rapid Detection of SARS-CoV- 2 (256082, 256089)1105 KB |
Becton Dickinson Holding Ptd Ltd |
9/12/2021 |
|
BD Kit for Rapid Detection of SARS-CoV-2 (256091, 256113, 256114)4556 KB |
Becton Dickinson Holding Ptd Ltd |
9/12/2021 |
|
SD Biosensor Standard Q COVID-19 Ag3008 KB |
SPD Scientific Pte Ltd |
31/12/2021 |
|
PHASE Scientific INDICAID® COVID-19 Rapid Antigen Test396 KB |
SDT Molecular Pte Ltd |
24/01/2022 |
Antibody (Serology) Tests
|
PUO Test |
Distributor |
Authorization Date |
|
GENSCRIPT cPass™ SARS-CoV-2 Neutralization Antibody Detection Kit942 KB |
Genscript Biotech (Singapore) Pte. Ltd. |
30/11/2021 |
| bioMérieux VIDAS® SARS-COV-2 IgM312 KB | bioMérieux Singapore Pte Ltd |
24/12/2021 |
| Abbott Alinity i SARS-CoV-2 IgM1281 KB | Abbott Laboratories (Singapore) Pte Ltd | 29/12/2021 |
| Restalyst COVID19N-REAAD™ Anti-SARS-CoV-2 Nucleocapsid Protein IgG ELISA460 KB | Restalyst Pte Ltd | 29/12/2021 |
| Beckman Coulter Access SARS-CoV-2 IgG291 KB | Beckman Coulter Singapore Pte Ltd | 31/12/2021 |
| Beckman Coulter Access SARS-CoV-2 IgM292 KB | Beckman Coulter Singapore Pte Ltd | 31/12/2021 |
Other Tests
|
PUO Test |
Distributor |
Authorization Date |
|
Silver Factory Technology TracieX Breathalyser (Version 2.0.)1355 KB |
Silver Factory Technology Pte Ltd |
18/01/2022 |
References:
COVID-19 Test Kits Authorized for Professional Use