A low-cost diagnostic test kit that can confirm Covid-19 in just two hours has been developed by the Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST). The test kit, funded by the Department of Science and Technology, called Chitra GeneLAMP-N, is highly specific for SARS-CoV-2 N-gene and 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 tests performed at NIV Alappuzha — authorized by ICMR — show that Chitra GeneLAMP- N has 100 per cent accuracy and matches with test results using RT-PCR. This has been intimated to ICMR, the authority to approve it, for Covid-19 testing in India, following which a license needs to be obtained from the Central Drugs Standard Control Organisation (CDSCO), for manufacture,” the DST said.
Current PCR kits in India enable detection of the E-gene for screening and RdRp gene for screening and RdRp gene for confirmation. Chitra GeneLAMP-N gene testing will allow confirmation in one test without the need for a screening test and at much lower costs.
The 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 two hours. A total of 30 samples can be tested in a single batch in a single machine allowing a large number of samples to be tested each day.
Prof Ashutosh Sharma, secretary GST, said that the development of a novel, inexpensive, rapid confirmatory for the diagnosis is a compelling example of how a creative team of clinicians and scientists working together seamlessly can leverage knowledge and infrastructure to make relevant breakthroughs. “…This will have a global impact,” he shared.
According to SCTIMST, the testing facility can be easily set up even in the laboratories of district hospitals with limited facilities a can be easily set up even in the laboratories of district hospitals with limited facilities and trained laboratory technicians. The results can be read from the machine from the change in fluorescence. “The cost of testing with the new device for LAMP testing and the test kit for two regions of N-gene( including RNA extraction) will be less than Rs 1,000/test for the laboratory,” the institute said.