Institute claims test kit breakthrough

The test kit, which is specific to the virus’s 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.

A Trivandrum-based research institution under the Union science and technology ministry said on Thursday that it had developed a substitute diagnostic kit for Covid-19 that was less expensive and more accurate than the polymerase chain reaction (PCR) (reverse transcriptase- polymerase chain reaction) test to determine if a person has been infected by the virus.

Scientists at the Thiruvananthapuram-based institute said the testing kit, called Chitra Gene LAMP N, was highly confirmatory for the diagnosis of Covid-19. (Reuters file photo)

Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST) director Dr Asha Kishore said it was the first substitute for the PCR (or RT-PCR) test and it was a path-breaking development at a time the country is struggling with mounting cases of the coronavirus disease.

“Validation of our kit was done by the National Institute of Virology centre in Alappuzha, as directed by the Indian Council of Medical Research {ICMR}. It is cheaper, faster and maintains international standards. Now ICMR can include it in the list of approved tests in the country. Distinction between negative and positive graphs was superior to the standard PCR {test},” she said.

SCTIMST said Dr Anoop Thekkuveettil, a senior scientist of the biomedical technology wing of the Institute and scientist-in -charge of the division of molecular medicine under the department of applied biology, and his team developed the kit in three weeks.

Scientists at the Thiruvananthapuram-based institute said the testing kit, called Chitra Gene LAMP N, was highly confirmatory for the diagnosis of Covid-19 and detected the N gene of Sars- CoV 2, the virus that causes Covid-19, using the reverse transcriptase loop-mediated amplification of viral nucleic acid (RT-LAMP) technique.

This will be one of world’s first few, if not the first, confirmatory diagnostic tests for the N gene of Sars-CoV-2 using the RT-LAMP technique, they said.

The test kit, which is specific to the virus’s 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.

The new kit allows confirmation in one test without the need for a screening test.

Dr. Kishore said in new kit takes 10 minutes for the gene detection test and the sample-to-result time is less than two hours.

At least 30 samples can be tested in a single batch in a single machine and the lower waiting time will allow a large number of samples to be tested each day in a single machine in multiple shifts. The time taken for the traditional PCR or RT-PCR test is between five and six hours, said scientists.

The testing facility can be set up even in the labs of district hospitals with limited facilities and trained technicians. The results can be read from the machine from a change in the fluorescence level.

The new device for LAMP testing costs Rs 2.5 lakh and the test kit for two regions of the N gene( including RNA extraction) will be less than Rs 1,000; an RT-PCR machine costs. Rs 15-40 lakh and the PCR kit test between Rs 1,900 and 2500, scientists said.

The institute said it will waive licence fee to encourage industry to take up its technology for mass production to meet India’s immediate needs.

The Institute said it will invite expressions of interest from companies for transfer of technology to start large-scale production.