Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST) in Trivandrum, Kerala, has made headline news with its development of a low-cost diagnostic test kit capable of confirming Covid-19 in merely 2 hours. Identified as an Institute of National Importance under the Department of Science and Technology (DST), SCTIMST’s breakthrough carries significant implications for India’s battle against the ongoing pandemic.
About the Diagnostic Test Kit
The test kit, funded by the DST and named Chitra GeneLAMP-N, is incredibly specific for the N-gene of SARS-CoV-2, the virus responsible for Covid-19. This specificity allows it to detect two regions of the gene, ensuring that even if one region undergoes mutation during the virus’ spread, the test’s reliability remains uncompromised.
This kit functions as a confirmatory diagnostic test, utilizing reverse transcriptase loop-mediated amplification of viral nucleic acid (RT-LAMP) to identify the N Gene of SARS-COV2. The test results can be discerned by changes in fluorescence, which occurs when a substance emits light after absorbing light or other electromagnetic radiation.
Accuracy and Approval Process
The National Institute of Virology (NIV) in Alappuzha, Kerala, authorized by the Indian Council of Medical Research (ICMR) has confirmed the 100% accuracy of the Chitra GeneLAMP-N by comparing its results with those obtained using Reverse Transcription Polymerase Chain Reaction (RT-PCR). The kit’s developers have informed the ICMR, the approving authority for Covid-19 testing in India, of these promising results. Upon approval, a license from the Central Drugs Standard Control Organisation (CDSCO) will be sought for manufacturing.
Advantages of Chitra GeneLAMP-N
Chitra GeneLAMP-N offers several significant benefits. It allows for 30 samples to be tested simultaneously, thereby enabling a large number of daily tests. Unlike the Polymerase Chain Reaction (PCR) kits currently in use in India, which require an E gene detection for screening and an RdRp gene for confirmation, this test kit provides confirmation in a single test without needing a screening test.
Moreover, Chitra GeneLAMP-N makes confirmatory test results possible in 2 hours, with a detection time of 10 minutes. The total testing time, from RNA extraction in swab to RT-LAMP detection, is less than 2 hours. This makes it a cost-effective solution, priced at under Rs. 1000 per test. Additionally, the test can be set up even in the laboratories of district hospitals with limited facilities and trained laboratory technicians.
Understanding the Key Terms
A gene is a unit of hereditary information that achieves its effects by directing the synthesis of proteins. Genes are composed of Deoxyribonucleic acid (DNA), except in some viruses, which have genes consisting of a closely related compound called Ribonucleic acid (RNA).
Reverse Transcription-based Loop Mediated Isothermal Amplification (RT-LAMP) is a simple quantitative detection method. Here, a DNA copy of the viral RNA is generated by reverse transcriptase. Then, isothermal amplification increases the total amount of DNA. A reverse transcriptase (RT) is an enzyme used to generate complementary DNA (cDNA) from an RNA template, a process termed reverse transcription. Isothermal amplification enables rapid and specific amplification of DNA at constant temperature (60-65 °C).
The development of the Chitra GeneLAMP-N diagnostic test kit by SCTIMST is a significant advancement in India’s Covid-19 testing capabilities. This quick, accurate, and cost-effective method could potentially revolutionize the country’s fight against the ongoing pandemic.
