In a special press release today, 1st of May 2021 the Sri Lanka Institute of Nanotechnology (SLINTEC) announced obtaining the GMP license from NMRA for manufacturing their COVID 19 Rapid Test Kit RT-LAMP.
Since the beginning of COVID 19 spread in Sri Lanka early last year the researchers at SLINTEC started to find effective solutions for practical issues the country would be facing because of this pandemic. Developing a cost effective COVID 19 test kit was one such initiative and a research team from SLINTEC came up with a novel low cost test kit that they named RT-LAMP. This kit uses loop mediated isothermal amplification PCR coupled with reverse transcription (RT-LAMP) as a robust method for SARS-CoV-2 detection in clinical specimens.
In August last year their new test kit was validated against over 300 clinical samples received at the University of Sri Jayawardenapura. And also the kit was independently validated by the NMRA by testing the kit at MRI, IDH and Karapitiya hospital PCR laboratories.
After almost a year of dedicated and intense work, SLINTEC was able to successfully implement a quality management system at our production facility in compliance with NMRA GMP requirements. According to the press release manufacturing of trial batches is to commence commence soon, which will then be followed by commercial production of SLINTEC LAMP – our proprietary RT-LAMP.
Study results have demonstrated that SLINTEC LMAP can readily replace RT-qPCR test as a means for detecting SARS-CoV-2 transcripts within RNA extracted from nasopharyngeal and throat swabs displaying a sensitivity threshold almost equivalent to the gold standard RT-qPCR. Specificity of the RT-LAMP PCR technique is presently being analyzed and the results will be out soon. Switching to RT-LAMP translates into a three-fold decrease in total reagent cost and a potential four-fold increase in pipeline output. With this intervention by SLINTEC, the country is expected to save nearly Rs. 150 million a month on Covid19 testing.
Heartiest Congratulations to Prof.Neelika Malaviga and her team of dedicated Scientists for this great invention at this crucial point in time. I am sure all Sri Lankans should celebrate this occasion in the same spirit they showed when the National Cricket team won the World Cup. My wife and I as old retired teachers living in Canada with our 2 sons and their families have the pleasure to forward this write up by Sisira Kumara of the Sri Lanka Scientist to many other Sri Lankans living here as well as in other countries. “May you, Prof Malavige and the team have many more opportunities to give the world this kind of inventions” – is our sincere and fervent wish. Thank you.
Thank you very much.