Coronavirus (COVID-19): DESCRIBING IT as an “important breakthrough”, doctors at Kerala's Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST) said Thursday that they have developed a diagnostic kit that halves the time currently taken to detect COVID-19. SCTIMST director Dr Asha Kishore told The Indian Express that the kit, which reduces the confirmation time from the current 4-5 hours to two hours, was originally being developed for the detection of DNA of Mycobacterium TB over the past two years and was scheduled for clinical trials in March. Kishore said the new tool, called Chitra GeneLAMP-N, is more effective because it detects two transcripts of the N-gene of SARS COV2, or COVID-19. The Institute is now awaiting certification validation from the Indian Council of Medical Research (ICMR), and a go-ahead from the Central Drugs Standard Control Organisation (CDSCO) for manufacturing the kits. “This is the most important breakthrough that the Institute has made in any field in the past few decades,” Kishore said. Based in Thiruvananthapuram, the SCTIMST functions under the Ministry of Earth Sciences. When contacted, Dr Raman R Gangakhedkar, Head of the Epidemiology and Communicable Diseases Division of ICMR, described the development as “a big thing for us and the country”. “But the ICMR first has to validate it to see the accuracy and the sensitivity of the test. This validation should take around two weeks, maybe even less. Once that is done, if the Institute has an industry partner who can produce in bulk, they can start rolling it out,” he said. Kishore said the kit detects the N Gene of SARS COV2 using a method called reverse transcriptase loop-mediated amplification of viral nucleic acid (RT-LAMP). She said tests conducted at the National Institute of Virology (NIV) lab in Alappuzha showed “100 per cent accuracy and 100 per cent congruence with results using RT-PCR”, which is the tool that is currently used in India. PCR kits enable detection of the E gene in the first screening. If this stage shows a positive result, a second screening of the RdRp gene is carried out for confirmation. According to Kishore, Chitra GeneLAMP-N reduces the testing from a two-step process to one step. She said that once the RNA is extracted through a throat swab and amplified, the new test can detect COVID-19 in 10 minutes, while the PCR test takes one-and-a-half hours. “Moreover, 30 samples can be tested in a single batch in a single machine and the significantly lower waiting time will allow large number of samples to be tested each day in a single machine in multiple shifts,” she said. “One of the big advantages of this kit is that you don’t need Bio Safety Level 2 or 3 labs for testing. Any lab and even district hospitals can carry them out. They are also far cheaper with the device costing Rs 2.5 lakh as opposed to the RT PCR machines, which can cost between Rs 15-40 lakh, and a PCR kit between Rs 1,900-2,500 per test,” Kishore said. “We had already transferred the technology to Agape Diagnostics Ltd in Ernakulam, a leading company in vitro-diagnostics, and they are waiting for permission to start rolling these kits out,’’ she said. Kishore said the kit follows the guidelines of the Center for Disease Control (CDC) in the US, which has recommended the detection of two regions of N-gene for confirmation of COVID-19 by any gene amplification technology. Don't miss these articles on Coronavirus from the Explained section: ‣ How coronavirus attacks, step by step ‣ Mask or no mask? Why the guidance has been shifting ‣ Besides a face cover, should I wear gloves when I go outdoors? ‣ How the Agra, Bhilwara and Pathanamthitta Covid-19 containment models differ ‣ Can coronavirus damage your brain?
