ECONOMYNEXT – Sri Lanka Institute of Nanotechnology, a public private partnership for developing advanced technologies said the island’s medical regulator had approved its manufacturing facility to produce a Coronavirus test kit based on RT-LAMP technology which will give quicker results.
The National Medical Regulatory Agency had last year validated the kit as several state hospitals, the agency said.
“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 (good manufacturing practices) requirements,” SLINTEC said in a twitter.com message.
“Manufacturing of trial batches will commence soon, which will then be followed by commercial production of SLINTEC LAMP – our proprietary RT-LAMP.”
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.
— Sri Lanka Institute of Nanotechnology (SLINTEC) (@slintec_lk) May 1, 2021
Reverse transcription loop-mediated isothermal amplification (RT-LAMP) processes usually target specific gene sequences in a single process, rather than two-step process in older PCT tests which slashes the time.
The Chief Medical Officer of Colombo Municipality Ruwan Wijayamuni has said various versions of SAR-Cov-2 variants were present in the country including those with S-drop genes
SLINTEC said its test kit was validated against existing RT-qPCR test at the University of Sri Jayawardenapura using over 300 clinical samples in Aug 2020.
The NMRA had also independently validated by the NMRA by testing them at the Medical Research Institute, the Infections Diseases Hospital and Karapitiya hospital, SLINTEC said.