MyLab starts making RNA extraction kits for crucial Covid-19 test

There is a huge shortage in India of these kits, which are critical in extracting sufficient quantities of RNA for accurate molecular diagnosis

With a growing shortage of RNA extraction kits across the world, Pune's MyLab Discovery Solutions, the first Indian company to get approval for Covid-19 diagnostic kits, has now also come up with its own RNA-extraction kits. India currently imports almost its entire requirement of RNA extraction kits and sources say that it has around 300,000 kits lying with the country. 

The reverse transcription-polymerase chain reaction (RT-PCR) test cannot be conducted without the RNA extraction kit. RNA or ribonucleic acid is the carrier of genetic information of certain viruses. For a successful and accurate PCR test (a molecular diagnosis), it is necessary to extract sufficient quantities of virus RNA. No matter how good an RT-PCR kit is, it would miss the virus unless sufficient quantities have been extracted. 

Meanwhile, with the Indian Council of Medical Research (ICMR) asking states to hold rapid antibody testing before their accuracy could be reaffirmed, the demand for RT PCR testing is only set to rise. 

"We have received the approval from the ICMR for our RNA extraction kit as well last Saturday. We started manufacturing these kits already and can make around 1 -1.5 lakh RNA extraction kits per day by May," said Hasmukh Rawal, the managing director of MyLab. He explained that without the RNA extraction kit the RT-PCR kit is like a car without the wheels. 

The US is targeting 500,000 tests per day and is facing a shortage of RNA extraction kits. Rawal said that they started working on developing the RNA extraction kit and managed to do so within a month or so. 

Why it is important in the Indian context is that the country has around 300,000 RNA extraction kits now. While requisitions have been made for more kits to come, it would take sometime. Having an indigenous kit would help to ramp up testing. Sources suggest that India has around 3 lakh units of RNA extraction kits and at the present rate of testing (about 38,000 per day), this would last for around a week. Some states like Madhya Pradesh have already indicated that stocks of RNA extraction kits are depleting. 

"There are roughly around 300,000 RNA extraction kits in the country now. Orders have been placed for more. But we are almost 99 per cent import dependent for these kits," said an industry source. The person added that when RT-PCR testing picked up, most states only ordered the PCR kits and not the RNA extraction kits along with that. This has further worsened the crisis. 

Sources say that India has placed orders for 3 mn RNA extraction kits but is yet to receive them. 

Reports suggest that Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST) has also developed a novel RNA extraction kit called Chitra Magna. SCTIMST could not be immediately contacted.