SLINTEC obtains NMRA GMP license to manufacture proprietary RT-LAMP in Sri Lanka
In an effort to increase the diagnostic capacity for COVID-19 virus in the country, SLINTEC rapidly repurposed its staff and facilities in April 2020 to develop cost-effective COVID-19 diagnostic test kits, including RT-LAMP-PCR to detect viral RNA.
SLINTEC RT-LAMP kit was validated against the existing RT-qPCR test at the University of Sri Jayawardenapura using over 300 clinical samples in Aug 2020 (https://bit.ly/3geYbuk). In addition, our product was independently validated by the NMRA by testing them at MRI, IDH and Karapitiya hospital PCR laboratories.
We are pleased to announce that after almost a year of dedicated and intense work, we were able to successfully implement a quality management system at our production facility in compliance with NMRA GMP requirements. Manufacturing of trial batches will commence soon, which will then be followed by commercial production of SLINTEC LAMP – our proprietary RT-LAMP.
Study results demonstrate that SLINTEC LAMP can readily replace RT-qPCR 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. 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.