LOLC Advanced Technologies launches RT-LAMP Test Kit for COVID-19 Detection for the first time in Sri Lanka

New biotech product launch from Sri LankaDilip Fernando

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

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.

Source: https://island.lk/lolc-advanced-technologies-launches-rt-lamp-test-kit-for-covid-19-detection-for-the-first-time-in-sri-lanka/

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