SINGAPORE – The first antigen rapid test (ART) kits for Covid-19 to be developed and manufactured in Singapore have been approved for retail sale by the Health Sciences Authority (HSA) under the Pandemic Special Access Route.
Local diagnostics and reagents company Cellbae, which developed the self-test kit, said it decided to establish research and manufacturing in Singapore to better serve people here and in the region after the major supply chain disruption caused by the pandemic.
Called TEP@RT, the ART kit targets the nucleocapsid antigen of the Sars-CoV-2 virus.
Cellbae research and lab director Soh Jun Hui said as most of the mutations, such as the Delta and Omicron variants, occur on the spike antigen, detecting the nucleocapsid antigen is crucial for a self-test kit to remain highly accurate.
He said the pair of capture and detector antibodies have been optimised so that the virus can be detected with high sensitivity even after it mutates.
A highly sensitive ART would allow even a low viral load to be detected.
Research for the self-test kit started at end-2021.
Dr Nadjad Abdul Rahim, Cellbae’s operations and product development director, said that for now, the company can produce 10,000 kits a day, which can be scaled up to 100,000 kits a day.
All manufacturing is done at its Science Park facility in Pasir Panjang.
Dr Nadjad added that Cellbae makes critical reagents, such as enzymes, oligonucleotides and nanoprobes, for diagnostics and research applications.
Dr Soh and Dr Nadjad worked on their PhDs under the supervision of Professor Jackie Y. Ying, co-founder of Cellbae. She also heads the NanoBio Lab at the Agency for Science, Technology and Research.
The company said the price of the ART kit will be competitive, and it is in talks with a retailer.
Other local ART kit manufacturers such as Camtech Diagnostics and SG Diagnostics have not been able to get HSA approval for retail sale.
Cellbae chief executive Muhammad Tani Tabiin said: “Our next products are RT-PCR assays for poultry tests and rapid test kits for food pathogens and meat speciation, which are very important for food safety and security.
“We are also working on rapid test kits for various infectious diseases as well as diabetes.”
Meanwhile, it is developing rapid test kits for avian influenza, mycoplasma gallisepticum, mycoplasma synoviae and Salmonella enteritidis, which are significant diseases in poultry production and food safety.
Cellbae is also developing rapid test kits for E. coli strain O157:H7 and Salmonella enteritidis which are more sensitive than currently available test kits and faster than RT-PCR assays.
In addition, the company is creating glucose tests for the community screening of diabetes. The simple and affordable rapid test kits, which do not require fasting, will enable early diagnosis of diabetes at scale.
Also in the works are rapid test kits to detect mosquito-borne diseases dengue, chikungunya and zika, as well as sexually transmitted diseases.