LOLC firm’s RT-LAMP Test Kit for COVID-19 detection
View(s):Across the world, the outbreak of COVID-19 has spurred widespread scientific research from prevention, cure to detection. And in this context, 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 Organisation which is the 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, the company said in a media release.
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.
CNDL is a joint venture 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 Ltd’s shareholding of 50 per cent while SLINTEC bears the balance 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 analysing RNA extracted from more than 200 patient specimens supplied by SJP. This was followed by analysing virus samples isolated from positive patients supplied by the 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 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.
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