Uses of Chitra GeneLAMP-N Test Kit

Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum, a Department of Science and Technology (DST) Institute of National Importance, has developed a low-cost diagnostic test kit that may confirm COVID19 in two hours. The confirmatory diagnostic test, which uses reverse transcriptase loop-mediated amplification of viral nucleic acid (RT-LAMP) to detect the N Gene of SARS-COV2, will be one of the first of its kind in the world. The Chitra GeneLAMP-N test kit, which was supported by the DST, is extremely specific for the SARS-CoV-2 N-gene and can identify two sections of the gene, ensuring that the test will not fail even if one region of the viral gene undergoes mutation during its present development.

Sree Chitra Tirunal Institute for Medical Sciences and Technology

Established by the Government of Kerala as an advanced centre for medical specialities, the Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum, was elevated to the status of an Institute of National importance under DST, Government of India, by an Act of Parliament in the year 1980. The institute was mandated with the primary objective of research and development in biomedical technology and the development of postgraduate training programs in advanced medical specialties. This uniquely poised Institute serves as a tertiary referral centre and has a dedicated team of clinicians, scientists and engineers devoted to high-quality biomedical research and developing technologies in health care with an emphasis on cardiovascular and neurological diseases.

The Biomedical Technology Wing has been instrumental in establishing a medical device industry base in India by successfully developing and commercialising technologies for several devices and implants.  Some of the commercialised technologies include blood bags, membrane oxygenators, hydrocephalus shunts, artificial heart valves, dental materials, hydroxyapatite based materials, drug-releasing intrauterine devices and implants.

Advantages

• In a single batch, a total of 30 samples can be evaluated in a single machine, allowing for a high number of samples to be tested each day.
• In India, current PCR kits allow for the identification of the E gene for screening and the RdRp gene for confirmation. Chitra GeneLAMP-N gene testing will allow confirmation in a single test, eliminating the requirement for a screening test and lowering expenses (less than Rs. 1000 per test).
• Chitra GeneLAMP-N enables Covid-19 confirmatory tests to be completed in about two hours.
• The detection time is 10 minutes, and the sample to result in time is less than 2 hours (from RNA extraction in swab to RT-LAMP detection time).
• Even at the laboratories of district hospitals with minimal facilities and skilled laboratory staff, the testing facility can be quickly set up.

In a single batch, 30 samples can be evaluated.

“A single machine can test thirty samples in a single batch, and the greatly reduced machine waiting time will allow a huge number of samples to be examined each day in a single machine across numerous shifts.” The testing facility can be built up quickly, even in district hospital laboratories,” Asha explained. The machine’s output can be read by noticing the change in fluorescence.

SCTIMST created the RNA extraction kits, as well as the GeneLAMP-N test kits and the testing apparatus. The Department of Science and Technology financed the entire research and development of Chitra GeneLAMP-N.

Awaiting approval from the ICMR.

Chitra GeneLAMP-N is now awaiting approval from the Indian Council of Medical Research (ICMR) for Covid-19 testing. The kit was developed in under three weeks by a team led by senior scientist Anoop Thekkuveettil.

Chitra Gene Lamp Test Kit

“ICMR had authorised the National Institute of Virology (NIV), Alappuzha, to validate the tests and the CDSCO had provided a licence for the same. The test at NIV found that Chitra GeneLAMP-N showed 100 per cent accuracy and congruence with the RT-PCR results,” said SCTIMST director Asha Kishore.
The kit detects the N Gene of SARS-CoV-2 using reverse transcriptase loop-mediated amplification of viral nucleic acid.  “Using Chitra GeneLAMP-N, gene detection can be done in 10 minutes and the sample-to-result time,” said Asha. 

Conclusion:

The detection time is 10 minutes, and the sample result in time is less than 2 hours (from RNA extraction in swab to RT-LAMP detection time). In a single batch, a total of 30 samples can be evaluated in a single machine, allowing for a high number of samples to be tested each day.

Sree Chitra hospital neurology appointment development of an innovative, inexpensive, rapid confirmatory test for the diagnosis of COVID 19 in record time is a remarkable illustration of how a collaborative team of doctors and scientists can harness knowledge and infrastructure to produce significant breakthroughs. The creation of a Technology Research Center at SCTIMST and four other DST institutions.