The new virus SARS-CoV-2 causes coronavirus disease 2019 (COVID-19), currently classified as a pandemic. The symptoms of COVID-19 are strikingly like other respiratory diseases and some patients can be asymptomatic too, so tracking the novel coronavirus is a difficult task. Since the novel coronavirus has no vaccine or cure till this time, there is a drastic need for rapid, specific, and sensitive SARS-CoV-2 detection technology to control the spread and contain the virus.
A current method for SARS-CoV-2 diagnosis is RT-PCR test, which detects the presence of viral nucleic acids in nasopharyngeal swab samples. But it has some shortcomings like it requires complex equipment, needs extensive training for potential users, and gives rise to a small number of false negative results, which will increase the conditions to spread the virus in the community much faster. Further, the test needs 6 hours for completion and turnaround time is about 10 hours, so that results could be obtained only by next day. In remote places the turnaround time increases to days depending on the distance the samples need to travel and waiting time for testing in a lab with Real Time PCR technology.
The new reverse transcription loop-mediated isothermal amplification (RT-LAMP) is a one-step nucleic acid amplification method to multiply specific sequences of RNA. This is a one-step nucleic acid amplification method to multiply specific sequences of RNA of the coronavirus. Here the RNA is first made into cDNA (copy DNA) by the usual reverse transcription. Then the DNA is amplified by the LAMP technique. Although the LAMP technique is used in western countries for the past 5 years or more, the technique is new to the Indian IVD industry.
RT LAMP technology is a type of isothermal reaction. It has many advantages over Real Time PCR technology during this pandemic. Since it is based on nucleic acid (RNA/DNA) amplification in one temperature (Isothermal), expensive thermal cycler or a real time PCR machines are not required. When compared to some PCR technology-based kits, the assay is so fast that results can be obtained in 30 minutes and positive samples amplify in as early as 10 minutes. This means that COVID-19 testing centers can report with accuracy in less turnover time.
RT LAMP technology can achieve the benefit of RT-PCR (sensitivity and specificity) and antigen testing kit (low turnaround time). This technology does not have laborious preparation as in the case of RT-PCR. It is cost effective and does not need complex expensive equipment. Assays can be performed with minimum skill and minimum infrastructure.
Agappe is proud to announce the first Indian company to commercially launch the RT-LAMP based assay the LUME Screen-nCOV and the RT-LAMP analyzer, Mispa LUME to the market. The assay is designed considering the Indian conditions and we believe that with this confirmatory, accurate, rapid, low-cost, and user-friendly molecular diagnostic method, our country can fight the COVID-19 pandemic at a better pace.
The author is Technical Director, Agappe Diagnostics Limited