With the rise in the number of reported novel coronavirus (COVID-19) disease cases in India, the government is exploring the possibility of allowing private laboratories to ramp up testing.
As of now, the entire testing for coronavirus infection is done by government laboratories under the Indian Council of Medical Research (ICMR). The tests are done by 52 viral research and diagnostic laboratories (VRDL) spread across India. The National Institute of Virology (NIV) at Pune – the apex laboratory – is monitoring VRDLs, marshalling resources and setting standards.
Currently, the government is testing only those people who are sick, came into contact with infected people, and those with a travel history to high-risk countries such as China, South Korea, Italy and Iran.
Despite best efforts, the government labs are only able to do 6,000 tests a day with a waiting period of two days. Health care experts say the capacity is woefully short for a country with a population of 1.3 billion. To date, India has reported 137 cases and three deaths, although those numbers may not reflect reality because of low testing rates.
This is where the 100 odd NABL-accredited commercial diagnostic laboratories can play a big part.
According to executives of private diagnostic firms, allowing private labs would help scale up testing by 10 times the current numbers.
They also say that the waiting time for the patients will come down significantly from the current two days to 12 hours. The improvement in access to testing and better turnaround times will help doctors identify cases at an early stage. They cite the example of South Korea, which is able to contain COVID-19 to large extent by aggressive testing and quarantine measures.
“The government told us to be ready, we are waiting for the licence to go ahead,” said Dr Sushil Shah, Chairman of Metropolis Healthcare. Metropolis is one of India’s largest diagnostic chains with a network of 119 laboratories. A dozen labs are accredited by NABL.
Shah said they have the capability to scale it up to 15,000 tests per day.
It isn’t Metropolis alone, other lab chains such as Suburban Diagnostics, iGenetic Diagnostics and Core Diagnostics have all told Moneycontrol that they are prepared to conduct tests for COVID-19. Calls and messages sent to Om Manchanda, CEO of India’s largest diagnostic chain Dr Lal Pathlabs, remain unanswered.
“NIV is the nodal body in India. They are creating standard operating procedures (SOPs) with ICMR. So we will wait to hear from them on what sort of protocols they want us to follow. They’re only looking at giving it to NABL-accredited private labs that are biosafety level compliant,” said Dr Sanjay Arora, Managing Director of Suburban Diagnostics.
The World Health Organisation advises biosafety level-3 for labs that deal with coronavirus.
The test for COVID-19 will be expensive, the executives say.
The cost of processing a single sample by the government labs is about Rs 6,000. So the cost of the test is estimated to range between Rs 9000 and Rs 11,000. The government is also expected to fix the pricing of the tests to avoid profiteering.
In India, ICMR is prescribing polymerase chain reaction (PCR) test to detect the virus. The PCR test basically works by amplifying the genetic material of the virus. If the novel coronavirus is present in the swab samples of the person, then it gets amplified. The test requires primers, probes, PCR reagents, positive and negative controls, and SOPs. Moreover, transportation and logistics, the infrastructure of the lab like biosafety, and the expertise and experience of lab technicians are key to quality tests and reliable results.
“The PCR test is not that complex and is scalable,” says Zoya Brar, Founder and CEO of Gurgaon-based CORE Diagnostics. “We can reduce the waiting time to four to six hours by increasing throughput,” Brar said.
Meanwhile Roche Diagnostics, Thermofischer Scientific and many others are bringing high throughput machines to India, which will increase the capacity to test significantly.
However, an ICMR official who didn’t want to be named said the biggest concern of the government was safety issues like cross-contamination and test quality.
“Firstly, the disposal of biomedical waste is very important. Secondly, the sample collection method should be proper. One needs to use a proper kit for collection. Otherwise, you’re exposing phlebotomists. Another aspect that worries the government is the lab itself; you need to have a biosafety cabinet where you open these samples and they have to have an extraction process, they have to go through Hepa filters before they’re exposed to the environment,” said Arunima Patel, Founder and MD, iGenetic Diagnostics.
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