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COLUMNS
COVID-19 Diagnostic Kits: The Singapore Story
Singapore-based companies and research institutes contribute to the fight against COVID-19 through development of diagnostic test kits for COVID-19 testing.

Singapore prizes itself as one of the leading biomedical sciences and biotechnology hubs in Asia. From start-ups to multinational companies, Singapore has been a choice location for biotechnology and biomedical companies to expand its reach to the Asia Pacific market. With its skilled talent base from local research institutes as well as large pool of biotechnology start-ups, Singapore has shown to emerge as a forerunner in development and manufacturing of biotechnology and biomedical resources needed to fight the COVID-19 pandemic. It was reported in June 2020 the medical technology sector in Singapore saw a 5.9 percent increase attributed to expanding demand for export of medical devices amid the COVID-19 pandemic.1 Number of cases and deaths due to COVID-19 are still on the rise across the world, biotechnology companies in Singapore ramp up efforts to provide effective and accurate diagnostic kits with reduced turnaround times.

The Health Sciences Authority (HSA) in Singapore has been pushing for faster approval of COVID-19 diagnostic tests since 29 January 2020. With its commitment to ensure the availability of diagnostic tests in Singapore, the HSA set up a provisional authorisation process to increase the development and variety of diagnostic tests available in Singapore. It has also been assisting local and multinational companies including research institutions for regulatory and scientific advice. At time this article was written, there have been a total of 96 COVID-19 diagnostic tests approved and received provisional authorisation by the HSA.2 All of which include those developed by research institutes, local biotechnology companies as well as multinational companies.

Here we summarise some of the main types of diagnostic kits which have been provided with provisional authorisation that were developed and commercialised by Singapore biotechnology companies and research institutes.

Fortitude Kit 2.1

Type of Test: Real-time Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) Test

Type of Sample: Nasopharyngeal and oropharyngeal swabs

How it Works: The kit makes use of RT-PCR technology to qualitatively detect presence of SARS-CoV-2 specific RNA from respiratory samples.

Development and Commercialisation: The Fortitude Kit was one of the earliest diagnostic tests deployed in Singapore. It was developed by a team of researchers at the Agency for Science, Technology and Research (A*STAR) in Singapore together with the Department of Laboratory Medicine at Tan Tock Seng Hospital (TTSH). Initial production and development of the kit was supported by the supported by the Diagnostics Development (DxD) Hub, a national initiative led by A*STAR’s commercialisation arm, A*ccelerate. In February 2020, Singapore-based biotechnology company, MiRXES received provisional authorization of the first version of the test (Fortitude Kit 2.0e) from Singapore’s Health Science Authority (HSA) to supply the Fortitude kit. A*STAR granted technology licence under a contract to MiRXES for manufacture and distribution of the Fortitude kit. Later in 8 May 2020, an improved version, the Fortitude Kit 2.1 was granted provisional authorisation by HSA.

iolidics 2019-nCoV IgG/IgM Detection Kit

Type of Test: Antibody Detection Test

Type of Sample: Human serum, plasma, and venous whole blood

How it Works: Qualitative detection of SARS-CoV-2 antibodies, IgG/IgM from human serum, plasma or venous whole blood. The ten-minute detection test was designed to complement other confirmatory tests such as those using RT-PCR technology. Results are meant to be interpreted together with clinical presentation.

Development and Commercialisation: Singapore-based MedTech start-up from the National University of Singapore (NUS), Biolidics Limited has been appointed as an exclusive distributor for this rapid COVID-19 test kit in the United States. Other approvals for use of its test kit has been granted by the European CE marking as well as the Food and Drug Administration in the Philippines.

RESOLUTE 2.0 Assay

Type of Test: Multiplex Real-time RT-PCR Test

Type of Sample: Nasopharyngeal Swabs

How it Works: Direct amplification of SARS-CoV-2 RNA from respiratory samples in Universal Transport Medium without the need for RNA extraction. The test provides qualitative detection of SARS-CoV-2 viral nucleic acid using real-time RT-PCR. Specimens are drawn from individuals who present acute phase signs and symptoms of infection and are suspected of COVID-19.

Development and Commercialisation: RESOLUTE 2.0 was developed by A*STAR and DSO National Laboratories in Singapore (DSO). Advanced MedTech Holdings (AMTH), a global medical technology company headquartered in Singapore has been granted the licence to manufacture and distribute the kit for clinical use. The Rapid Automated Volume Enhancer (RAVE) robotics lab system developed by A*STAR’s Advanced Remanufacturing and Technology Centre (ARTC), the Singapore Institute of Manufacturing Technology (SIMTech) and DxD Hub will also be distributed together with the kit to expedite the testing process.

ASSURE® SARS-CoV-2 IgG/IgM Rapid Test

Type of Test: In vitro immunochromatographic test

Type of Sample: Human plasma, serum, finger pricked whole blood or whole blood with anti-coagulants

How it Works: Detects antibodies IgG and IgM from the samples, which are produced by the human body when infected by SARS-CoV-2. The rapid antibody test kit will assist in determining whether an individual has been previously exposed to the virus. It will also help to identify asymptomatic individuals or those with only mild symptoms. Results are confirmed with clinical presentation and supplemented testing such as RT-PCR.

Development and Commercialisation: The kit was developed by MP Biomedicals Asia Pacific Pte Ltd in collaboration with A*STAR in Singapore. Utilising proprietary synthetic SARS-CoV-2 proteins, MP Biomedicals developed the product based on its lateral flow platform. The Diagnostics Development (DxD) Hub, a national platform hosted by A*STAR's commercialisation arm, A*ccelerate, co-developed the validation protocols and quality controls. It was then evaluated by the Department of Laboratory Medicine at National University Hospital (NUH), Singapore, and demonstrated promising results when tested on both whole blood and serum.

SARS-CoV-2 Surrogate Virus Neutralization Test

Type of Test: Blocking assay for qualitative detection of neutralizing antibodies against SARS-CoV-2

Type of Sample: Human blood

How it Works: The test detects functional neutralizing antibodies produced by the human body during infection by SARS-CoV-2. These antibodies are able to block the binding of the coronavirus spike protein to the host receptor, angiotensin-converting enzyme 2 (ACE2), mimicking the virus-host interaction.

Development and Commercialisation: SARS-CoV-2 Surrogate Virus Neutralization test (sVNT) was developed by scientists from Duke-NUS Medical School, in close collaboration with National Centre for Infectious Diseases (NCID), Agency for Science, Technology and Research (A*STAR)’s Institute of Molecular and Cell Biology (IMCB) Singapore, and GenScript Biotech Corporation. The sVNT kit is commercialised by GenScript and offered worldwide under the brand cPass™ for research use only. It has filed for Emergency Use Authorisation with the US Food and Drug Administration and this filing is currently under review.

ProTect COVID-19 RT-qPCR Kit 2.0

Type of Test: RT-qPCR test

Type of Sample: Nasopharyngeal swabs

How it Works: Qualitative detection of RNA from SARS-CoV-2 virus present in the patient’s sample. The kit RT-PCR technology to identify RNA of the novel coronavirus by targeting multiple locations on the genetic material.

Development and Commercialisation: The ProTect COVID-19 RT-qPCR kit was developed by Singapore biotechnology firm, JN Medsys. Provisional authorisation for the kit was granted by the HSA in Singapore on 7 July 2020. It has also since been awarded with approval by the Food and Drug Administration (FDA) of the Philippines and currently seeking approval from the United States FDA.

VereCoV™ Detection Kit

Type of Test: Multiples RT-PCR/ Microarray-based in vitro diagnostic test

Type of Sample: Respiratory swab or throat aspirate

How it Works: This kit utilizes a fast PCR-microarray-based diagnostic test together with a multiplex system to qualitatively detect specified genes of SARS-CoV-2. The test provides a Lab-on-Chip option for diagnostic testing and targets three genes; ORF1ab, Spike (S), and Nucleocapsid (N).

Development and Commercialisation: This detection kit is a portable Lab-on-Chip platform designed and developed by Singapore biotechnology company, Veredus Laboratories Pte Ltd. In early March 2020, the Singaporean government implemented the use of rapid COVID-19 test kits for screening nasal swab samples at Singapore’s checkpoints. Collaborating with the Home Team Science and Technology Agency (HTX), Veredus Laboratories developed a new COVID-19 test kit for this purpose.

This article is meant to provide a summary of the main types of COVID-19 diagnostic test kits developed in Singapore. For accurate information on the proper-use of each kit please refer to the HSA website or contact the company directly.

References:

  • Amala Balakrishner, (July 24, 2020) Singapore's factory output falls for the second consecutive month in June, The Edge. Retrieved from: https://www.theedgesingapore.com/capital/singapore-economy/singapores-factory-output-falls-second-consecutive-month-june

  • HSA Expedites Approval of COVID-19 Diagnostic Tests in Singapore via Provisional Authorisation, (n.d). Retrieved from: https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-19-diagnostic-tests-in-singapore-via-provisional-authorisation

 

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