COVID-19, the novel coronavirus infection, which began in Hubei Province, China in December 2019 transformed to an unprecedented worldwide crisis in great speed. The pandemic caused snap lockdowns, social distancing and an alarming number of loss of human lives across the world – all this, resulted in grave humanitarian and economic loss, globally. In Sri Lanka, the pandemic has claimed over 14,000 lives already. Ever since the first case was detected in early 2020, Sri Lanka experienced several lockdowns and travel restrictions which caused most economic activities in the country to come to a standstill.
Across the world, the outbreak of COVID-19 also spurred widespread scientific research from prevention, cure to detection. LOLC Advanced Technologies collaborated with the Sri Lanka Institute of Nanotechnology (SLINTEC) through Ceylon Nano Diagnostics Pvt Ltd. (CNDL) to introduce the loop-mediated isothermal amplification (LAMP) method for the first time in Sri Lanka to curb the limitations of the standard coronavirus detection method approved by the World Health Organization which is RT-qPCR method. This novel process is similar to the conventional PCR tests, with the exception that the nucleic acid amplification occurs at one temperature. As a result, certain mandatory equipment for PCR such as a thermal cycler is not required. This method of detection being quicker, easier to use, and more cost effective than RT-qPCR tests in terms of diagnosis, has many advantages such as wide pH and temperature ranges that are acceptable, the ability of the assay to accept non-processed samples, and the flexibility of the readout methods, all the while maintaining specificity and sensitivity that is about equal to that of the PCR tests.
Ceylon Nano Diagnostics Pvt Ltd. is a Joint Venture (JV) company established to produce RT-LAMP kits and other research and development initiatives related to the molecular diagnostics field. LOLC Advanced Technologies is the management entity for CNDL on behalf of Browns Pharma Limited’s shareholding of 50% while SLINTEC bears the balance 50% shareholding.
SLINTEC has successfully demonstrated the use of RT-LAMP as a robust method for SARS-CoV-2 detection in clinical specimens in Sri Lanka. Even though, several detection methods are available in the LAMP assay, SLINTEC has developed the RT-LAMP kit with the fluorescence detection which is the most sensitive method that can be performed using RT-PCR machine which is currently used for detection of COVID-19. After demonstrating the proof of concept, the SLINTEC RT-LAMP assay was validated against the existing RT-qPCR test at Sri Jayewardenepura University (SJP), by analyzing RNA extracted from more than 200 patient specimens supplied by SJP. This was followed by analyzing virus samples isolated from positive patients supplied by National Institute of Infectious Diseases (IDH) using RT-qPCR available at SJP. Subsequently, the SLINTEC RT-LAMP kit was validated independently by the National Medicines Regulatory Authority (NMRA) at three different laboratories (Infectious Diseases Hospital, Karapitiya Teaching Hospital and Medical Research Institute) for its performance. Having carried out a GMP compliance audit, the NMRA has also given the green light to manufacture the product at the CNDL production facility. In addition, the Ministry of Health has given their consent to use the LAMP technique in Sri Lanka. After a stringent compliance audit, the manufacturing facility was awarded the GMP Certificate to commence manufacturing and finally the product obtained the NMRA approval for commercial use in the Sri Lankan molecular diagnostics market. Although RT-LAMP is new to Sri Lanka, it is currently being used in several other countries including USA and UK.
Commenting about the collaboration, LOLC Group, Deputy Chairman Ishara Nanayakkara said, “At LOLC, our increasing investments in science, research and technology derives from our passion and thirst for knowledge and scientific innovation which is centered on local value addition. I am pleased to note that this collaboration has done just that and especially at a crucial stage of an evolving pandemic. As a Group, we are committed to continue to work and invest in such value additions whilst providing local scientists and researchers the opportunity and platform to explore and make use of their skills and knowledge”.
LOLC Advanced Technologies (Pvt) Ltd. is the research arm of the LOLC Group. The company provides advanced technological consultation support to companies under the LOLC umbrella in the fields of precision agriculture, process improvements for cinnamon agronomy and value addition, new product development in plant nutrition and agro-chemistry. LOLC Advanced Technologies was set up to explore sustainable business opportunities in the market with augmentation of Science and Technology. It is a wholly-owned subsidiary of LOLC Holdings PLC.
To capitalize on the marketing, distribution, technical and application services in the market, CNDL entered into an agreement with Avon Pharmo Chem (Pvt) Ltd., a long-standing leader in the molecular diagnostics market in Sri Lanka.
Dilip K. Fernando, CEO of Avon Pharmo Chem Pvt Ltd said, “Avon possesses the country’s best application, technical team and marketing processes in serving the biotechnology and molecular diagnostics laboratories. We are confident that the COVID 19 test kit produced in Sri Lanka can be instrumental in resolving the challenges faced by the country right now. As we have already received a better response from the private sector COVID-19 testing laboratories, we are fully engaged in training laboratory staff for adopting the technology faster so that all the laboratories can use the kit soon.”
Commenting, Dr. Naresh Handagama, CEO of SLINTEC said, “The COVID 19 test kit developed by the scientists at SLINTEC according to industry best practices, compliance and protocols, has been commercially launched for the Sri Lankan molecular diagnostics market. This is the first of its kind in our history that a test kit of this kind has been able to successfully pass the hurdles of very stringent GMP and NMRA standards certificates together with a series of other validations and trials in many laboratories. When COVID hit our country, many industry leaders engaged in various activities to support the government’s battle in combating the COVID 19 challenge. But, LOLC looked for sustainable ways of facing this issue by investing in science and technology expertise and infrastructure. When SLINTEC announced their engagement in test kit development, LOLC leveraged the idea that could support for future developments as well. This initiative is of great national importance as we are now able to produce this test kit locally and save the outflow of foreign currency from our country whilst better serving the nation with improved performance”.