Mylabs is India’s first local manufacturer of the gold standard RT-PCR tests for Covid-19, and Serum Institute has helped it increase its capacity.(REUTERS)
Mylabs is India’s first local manufacturer of the gold standard RT-PCR tests for Covid-19, and Serum Institute has helped it increase its capacity.(REUTERS)

Walk-ins may be key step as India looks to step up testing

According to experts in public health, industry and regulations, the country has the capacity to carry out a million tests a day but will need administrative will from across the states.
Hindustan Times, New Delhi | By Sanchita Sharma, New Delhi
UPDATED ON JUL 08, 2020 05:53 AM IST

The civic agency in Mumbai allowed on Tuesday people to get tested for Covid-19 without needing a doctor’s prescription, making it the first city in the country to allow walk-in tests – a step experts say is crucial to adequately scale up a process that alone could hold the key to beating back the outbreak.

India has till now carried out a little over 10 million tests but will need to ramp up this process significantly by setting a bar as high as 50 million tests by August 15, which would give authorities a far more adequate insight into how the virus may have spread in a population of over 1.3 billion people so that each of the infected can then be traced and isolated.

According to experts in public health, industry and regulations, the country has the capacity to carry out a million tests a day but will need administrative will from across the states. “We are not testing enough. We (India) have enough tests – we can make two million tests per week just in Mylabs and now there are multiple other companies making testing kits in India, but we’re just not testing more,” said Adar Poonawalla, CEO and owner of the Pune-based Serum Institute of India, which is the world’s largest vaccine manufacturer by volume.

Mylabs is India’s first local manufacturer of the gold standard RT-PCR tests for Covid-19, and Serum Institute has helped it increase its capacity.

India, which has the third highest number of Covid-19 cases in the world after US and Brazil, has done 7,661 tests per million people, which is less than 0.8% of its population. In comparison, the US has tested 11% of its population, Russia 16%, and the UK, 15%, according to data compiled by Worldometers.

Recent headway in efforts to ramp up testing have come from tools such as the rapid antigen kits (one of those used is the Standard Q from a South Korean company) and equipment-makers are pushing for more innovation to make testing devices that are easier to operate.

One such device was launched on Tuesday by Pune-based Mylabs, which unveiled India’s first fully-automated bench-top system designed to automate the process of testing using the reverse transcription polymerase chain reaction (RT-PCR) method.

“This machine can perform 400 tests a day with a single person operating it, which will help address any potential demand-supply gaps of highly skilled technicians for testing, thus saving us manpower and time and helping the country open up by testing faster, more efficiently and on a large scale,” said Poonawalla.

On-demand testing

As much as equipment and resources, India needs to allow walk-in tests, say experts. “The number of tests being done is not at all adequate. Given India’s population, we must do one million tests a day to diagnose and isolate the infected and it can be done only by making testing available on demand. Since rapid scale-up may not be possible using RT-PCR tests, antigen testing should be deployed at scale at point-of-care to increase community testing till the positivity rate falls below at least 2-3%,” said JVR Prasada Rao, former health secretary and a former UN special envoy for HIV/AIDS.

Poonawalla echoed the suggestion: “The government has to allow testing for asymptomatic people also because that is the only way we’ll know how many cases there are. People may ask, ‘Will it create panic?’, but there is no panic in knowing cases. We have to worry about deaths and treat the sick early so that they don’t die. To do that, you need to isolate and treat people who tested positive.”

China, which has 83,565 Covid-19 cases and a population comparable to India, has done 62,814 tests per million of its population , covering roughly 6% of its population. Its main strategy to stop infection has been focused mass testing and isolation in hard-hit cities and provinces, including Beijing, Mudanjiang city in Heilongjiang province, and Wuhan city in Hubei province.

“Testing is the only way to diagnose an infected person and stop further transmission. I am alarmed at the mishandling of the pandemic. Where are the labs to test and give results within an acceptable time frame? I am told test samples are piled up in labs in Andhra Pradesh and delays are huge. If results come after five days, the infection has already spread, so a lot must go into the strategy besides numbers. They have messed it up in a big, big way,” said K Sujatha Rao, former health secretary, Union ministry of health and family welfare.

“An antigen test is helpful in diagnosing the infection, like the ELISA test for HIV, which can be sent for confirmation trough RT-PCR. So having a point-of-care test like the antigen test can help scale up, which is what is being done in some states now,” said Rao.

Flattened peak

Increased testing leads to an initial spike in cases, followed by a plateau and then a steady fall as the sick get isolated and their close contacts are quarantined. “Low testing leads to high positivity rate, which is an indicator for need to ramp up testing. Since the pandemic is spreading in multiple waves in India, the focus areas should be on increasing testing in hot spots and merging hot spots, such as Andhra and Karnataka. Infections are fortunately limited in India, so ramping up testing in affected areas to test everyone and their contacts will make a difference, as it has in Delhi, were the peak has plateaued considerably,” said CK Mishra, former secretary with the ministries of health and environment.

With increased testing, positivity in Delhi fell from a weekly average peak of 30.4% in mid June to a weekly average of 10.4% on Tuesday. “Testing alone is not enough, the contacts must also be traced and quarantined to stop transmission,” added Mishra. That’s the second T and the I of the classic Test, Trace, Isolate, Treat approach.

“The plateauing in Delhi indicates adequate testing and containment, and this will sustain for a while before the numbers gradually hopefully begin to fall in early to mid-August, provided there are no slip-ups,” said Randeep Guleria, director, All India of Medical Sciences (AIIMS) Delhi on Tuesday.

Maharashtra, Tamil Nadu and Delhi, which together account for 60% cases in India, have per million testing numbers of 9,295, 18,185 and 33,178 respectively. Maharashtra has done the least tests, and has the highest positivity rate of 22%.

Telangana, with second lowest testing after Bihar, has positivity rate of 27.6%, which is three times the average national positivity rate of 9.43%.

Standardising numbers

India now has 1,115 labs equipped and approved for testing for Covid-19, which include 793 in the government sector and 322 in the private sector. That apart, states have begun using antigen-based tests that give results at point of care within 30 minutes.

But, increasing testing is not just about approving labs and kits, say experts.

“It’s also about ensuring quality of test kits, logistics in terms of supply to states, standardization of the testing protocols, and setting a minimum range that ought to be done. For example, you can’t have arbitrariness, where Telangana has tested 3,284 per million while Delhi has done 33,000 per million. There is no clarity or uniformity of approach,” said Rao.

Flattening the curve by testing even asymptomatic people can accelerate opening up with the new-normal safeguards like masks and social distancing. “How can governments, companies and economies open up if companies are not allowed to test its staff so that they feel and know they are in a safe environment? That can happen only with more testing,” said Poonawalla.

“We we must test more and should not worry about having more cases. Epidemiologists predict up to 50% of the world’s population will have Covid over the next few years, but that’s nothing to worry about because a very, very, very small percentage of that will have critical illness,” he added.

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