A Brief Note on First Made in India COVID19 Test Kit

Covid-19 diagnostics tests should use the real-time reverse transcription-polymerase chain reaction, commonly known as RT-PCR. The test looks for viral RNA in human samples. The process of amplifying a few copies of DNA to make millions of copies is known as a polymerase chain reaction. In addition to human samples, the test requires primers, probes, nucleotides, buffer solution, enzymes, and cofactors. 

The primary distinction between tests performed in a research laboratory and those performed in a diagnostic lab is that the latter’s results are utilised for clinical decision-making. As a result, diagnostic laboratories must be certified and follow the proper standard operating procedures, maintain sample flow directionality, and ensure that lab workers are adequately educated. 

Let us look at one development made by India in terms of the RT-PCR testing- The first covid-19 kit in India. 

Testing Kit in India

As India tackles the Coronavirus (Covid-19) outbreak, officials are most concerned about the inadequate testing facilities and pricey testing kits. To address this issue, the Pune founded molecular diagnostics corporation Mylab Discovery Solutions Private Ltd, which provides services to or specialises in molecular diagnostic equipments, created the first covid-19 kit in India– manufactured in the country for the Covid-19 pandemic in history of six weeks. 

The kit, known as the MyLab Pathodetect Covid19 of Qualitative PCR test, is the main or first to obtain commercial authorization from the Indian FDA or Central Drugs Standard Organisation furthermore known as CDSCO. Furthermore, MyLab is the single firm in India to have accomplished 100 percent sensitivity and 100 percent particularity in the ICMR review. 

The first covid-19 kit in India manufacturer, Pune based MyLab has numerous years of mastery and expertise in producing RT-PCR kits and now makes ID-NAT kits in screening for hospitals and blood banks, HBV, HCV kits, and Quantitative HIV at a facility certified by the Indian FDA or CDSCO and complying with MDR 2017 rule for manufacturing medical devices of the Classes D and C, the most strict and regulated items by the administration. Aside from that, MyLab has got permission from the DCGI which stands for ‘Drugs Controller General of India’ to produce the Covid-19 Qualitative kit at the similar capability. At the Research centre or hub of the Indian Council of Medical Research and Studies, the MyLab Covid-19 kit was assessed. 

The testing agency has worked hard to provide chopping perimeter or cutting edge technology in the country at a more cheap and reasonable cost. Because this test is founded on susceptible PCR technology, straight early-stage disorder may be specified with excellent accuracy, as demonstrated by the ICMR testing. The ICMR sampled, CDSCO ratified equipment also allows for speedier detection. 

It is estimated and will be a big milestone for India if test kits are sourced locally, as My Lab’s testing kit will cost approximately one-fourth of the present procurement cost. Furthermore, the kit identifies and screens the infection in 2.5 hours, as opposed to the 7+ hours required by the existing techniques. This indicates the kit to perform twice as many reactions on a single piece of equipment in the same amount of time. This is one of the advantages of the molecular diagnostic kits has developed. 

Brains behind the Patho detect

In the fight against the coronavirus pandemic, India has been chastised for its poor track record of testing individuals. This changed, owing to the efforts and trials of the virologist- Minal Bhosale, who provided a functional test kit only hours before giving birth to her daughter. 

The country has been chastised for not conducting enough tests. It had one of the lowest rates, with only 6.8 testing per million people. Initially, the testing was conducted for people who have visited high-risk nations, had come in touch with an infected person, or were medical personnel treating coronavirus patients. It was then stated that everybody hospitalised in the hospital with significant respiratory distress should be checked as well. However, if the infection circle expands daily, the numbers are projected to sky-rocket. 

Therefore, India has increased testing. Initially, only state laboratories were permitted to do the testing, but the authority has since been granted to numerous private labs as well. The increased testing has resulted to be extremely beneficial, but experts believe that the health system has big flaws that must be filled immediately to deal with the rising threat of the virus. 

Conclusion

As India ranked worst in terms of tests performed per million people. The figure was reduced to 6.8. Nations such as Singapore and South Korea were able to keep the rising numbers of infections under control by conducting more testing. So distant, the Government of India has acquired millions of tests from Germany to ease testing for Corona-virus patients all over the country. However, the reliance had proven problematic, as supply was becoming constrained owing to the grounded planes. This may alter with the approval of the manufactured in India Kits. Hence, the first Covid test kit in India was very helpful.