The Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST), here has developed a diagnostic test kit (Chitra GeneLAMP-N) which is highly confirmatory for the diagnosis of COVID-19 and detects the N Gene of SARS-CoV-2 using reverse transcriptase loop-mediated amplification of viral nucleic acid (RT-LAMP).
SCTIMST is an Institute of national importance, under the Department of Science and Technology.
Incidentally, this new kit is billed as one of the first few confirmatory diagnostic test for N gene of SARS-CoV-2 using the RT-LAMP technique.
According to the institute, this test kit which is highly specific for SARS-CoV-2 N-gene can detect two regions of the gene which will ensure that the test does not fail even if one region of the viral gene undergoes mutation during its current spread.
NIV-Alappuzha was authorized by the Indian Council of Medical Research (ICMR) to validate the tests and the tests performed at NIV Alappuzha found Chitra GeneLAMP-N to show cent per cent accuracy and congruence, which has now been intimated to ICMR.
The next step is approval of Chitra GeneLAMP-N by ICMR for COVID-19 testing in India and the license for manufacturing the kit.
According to SCTIMST, using Chitra Gene LAMP-N, the gene detection time is 10 minutes and the sample to result time (from RNA extraction in swab to RT LAMP detection time) will be less than 2 hours.
At least 30 samples can be tested in a single batch in a single machine and the significantly lower machine waiting time will allow large number of samples to be tested each day in a single machine in multiple shifts.
The testing facility can be easily set up even in the laboratories of district hospitals with limited facilities and trained laboratory technicians.
The institute has also developed the specific RNA extraction kits along with GeneLAMP-N test kits and the testing device. The research and development of Chitra GeneLAMP-N was fully funded by Department of Science and Technology, Govt of India.
Anoop Thekkuveettil, a senior scientist of the Biomedical Technology wing of SCTIMST in charge of the division of molecular medicine under the Department of Applied Biology led the team that developed the kit..