The Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST) here has achieved a breakthrough in developing a cost-effective confirmatory diagnostic test kit for COVID-19 using the RT-LAMP (reverse transcriptase loop-mediated amplification of viral nucleic acid) technique for detection of the ‘N’ Gene of the SARS-CoV-2 virus.
The tests conducted at the NIV, Alappuzha, found Chitra GeneLAMP- N to show 100% accuracy and 100% congruence with test results using RT-PCR.
An official release here said the test kit was awaiting approval by the ICMR for COVID-19 testing in India.
It added that the new gene testing method would allow confirmation in one test without the need for a screening test.
The test kit 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. The technique allows for gene detection in 10 minutes with the sample to result time (from RNA extraction in swab to RT-LAMP detection time) less than 2 hours. As many 30 samples can be tested in a single batch in a single machine.
The testing facility can be easily set up in laboratories of district hospitals with limited facilities and trained laboratory technicians. The device is estimated to cost ₹2.5 lakh and the test kit will be less than ₹1,000 per test for the laboratory. In contrast, an RT-PCR machine costs ₹15 to 40 lakh and the PCR kit ₹1,900 to 2,500 per test.
Anoop Thekkuveettil, senior scientist in biomedical technology, SCTIMST, and his team developed the kit in three weeks. The institute has transferred the technology to a firm based in Kochi and is awaiting manufacturing licence from the Central Drugs Standard Control Organisation.
