India has among the lowest testing rates for coronavirus in the world – at least that’s what the last available data showed. The country had tested fewer than 6,000 people until March 13: just five tests per million people compared to more than 4,000 tests per million in South Korea.
For days, a debate has raged over India’s conservative protocol, which limits coronavirus testing to only those who have travelled to coronavirus-affected countries in the last 14 days or those who have come in contact with confirmed cases – and have symptoms of the disease.
This means those without travel and contact history cannot be tested.
But this contradicts the government’s own definition of “suspect cases”, which includes a category of people who may not have such history.
Those with severe acute respiratory illnesses who require hospitalisation and whose condition cannot be explained by any other cause, even if they do not have travel and contact history, are considered “suspect cases” for Covid-19, the disease caused by the coronavirus, as per government guidelines.
The above case definitions are from guidelines issued by the Ministry of Health and Family Welfare on March 17 mandating that private hospitals report coronavirus suspect cases to the district authorities. (The same case definitions have been part of government guidelines at least from March 13.)
However, when it comes to testing suspect cases, this is what the March 17 document says: “In case the person has any such [travel or contact] history in the last 14 days and is symptomatic as per case definition of COVID-19, the person must be isolated in the hospital and will be tested for COVID-19 as per protocol.”
This means those who do not have travel and contact history – even if they are “suspect cases” – do not qualify for tests.
“This is an obvious contradiction,” said Dr T Sundararaman, former executive director of the National Health Systems Resource Centre, an advisory body to the health ministry. “The moment you have a suspect case, you should isolate the patient...This test has to be available to all suspect cases.”
Not testing suspect cases who are severely ill poses “a risk even to health workers”, Sundararaman said.
Dr Yogesh Jain, a physician who runs a community hospital in rural Chhattisgarh, said this contradiction was “completely crazy”.
“As physicians we are facing this problem where we are putting people on ventilators but are unable to check them for coronavirus,” he said. He sent samples of severely ill patients who met the “suspect case” definition to the All India Institute of Medical Sciences in Raipur, the sole designated government lab which is testing for coronavirus in Chhattisgarh. “They said we cannot test these samples because the testing guidelines don’t allow for it,” Jain said.
What are the dangers of this approach?
By restricting tests to only people with travel and contact history who are reporting severe symptoms, India runs the risk of failing to detect the spread of coronavirus in the wider community, say experts. This is called “community transmission” and it takes place when the infection spreads widely and cannot be traced to a known confirmed case.
“You [the government] are expanding your timeline and decreasing your chances of picking up cases early,” said Gangandeep Kang, director of the Translational Health Science and Technology Institute, in an interview to The Hindu. “In a best case scenario, all this testing is unnecessary and what you are doing is perfect. But even then, what have you lost by doing additional testing? You have wasted some money on kits, you have wasted some people’s time but you have bought assurance that the virus isn’t there.”
Not just public health experts, even state governments have criticised the Centre’s narrow testing protocol.
On March 16, Chhattisgarh government wrote to the Union health ministry, saying its testing policy meant doctors were “unable to send samples for testing even when they suspect cases on clinical grounds”. “We are concerned whether the Government of India will provide us with an adequate number of kits if we allow wider testing,” the note said.
State officials told Scroll.in expanding tests without the assurance of more kits from the Centre could lead to shortages at the state level.
Why is ICMR not expanding tests?
The ICMR has offered several reasons for restricting testing to symptomatic cases with travel and contact history. In an interview to the Indian Express, ICMR scientist Nivedita Gupta said it could lead to “futile testing”:
“If today, I am exposed to a suspect patient and I feel that this patient has Covid-19, and tomorrow I want to get myself tested because I am very scared. What is the flip side of this? The incubation period ranges from 2 to 14 days. If someone has a long incubation period, but tests negative, doesn’t that give a false sense of security to them when the test is meaningless? And then, if I tell people I cannot say if you are positive or negative, that person is going to want to get tested again and again. And, in this process, in a huge country like India, I’m not able to test people who genuinely may need testing because I’m wasting it on futile testing.”
Gupta also said it could lead to government hospitals getting swamped while tests – possibly to confirm a positive result – were still underway:
“Right now, we are stressing on home quarantine. But, if I test an individual who is asymptomatic or mildly symptomatic, and he is positive, then he would be requesting to be put in a hospital, saying to isolate me and you take care of me. Then what do I do? In a country like this, how many isolation beds, how many places does the government have for this?”
While this explains why the government is not testing those with travel and contact history who are reporting mild symptoms, it does not explain why the government is not allowing tests for severely ill patients without travel and contact history who are already in hospitals.
If such cases are confirmed, it would show community transmission has taken place. “I doubt whether the government even wants to know the truth,” said Dr Yogesh Jain.
The ICMR, however, insists it is taking steps to detect community transmission.
What is the ICMR’s strategy to detect community transmission?
Random sampling. The ICMR says each of the government labs testing suspected patients of coronavirus are also examining 20 samples every week of people reporting severe acute respiratory illnesses or pneumonia-like illnesses. If any of these random samples test positive for coronavirus, it would show the infection has spread in the community beyond those who have been in contact with confirmed cases. In this eventuality, ICMR says it would change its testing strategy.
So far, 500 samples tested at 51 labs between March 1 and March 15 show no evidence of community transmission, ICMR scientists said in a press conference on Tuesday. The results of another 520 samples would become available on Wednesday.
ICMR scientist Nivedita Gupta said many labs found it hard to even source 20 samples for testing in a week since there were few cases of hospitalisation for severe acute respiratory illnesses.
But experts question whether this is reflective of the narrow catchment area of the labs. For one, the samples are drawn only from government hospitals. Secondly, some of the labs are not attached to large government hospitals.
“Some test centres are not even representative of case load,” said Sundararaman. “The government needs to put in place a system to transport samples safely for testing.”
How much testing capacity does India have?
Could a lack of capacity explain the government’s conservative approach?
Health officials have said India has about 1.5 lakh coronavirus testing kits. The Indian Council for Medical Research is currently supplying the kits to a network of 52 government labs across India, with a capacity to do 6,000 tests a day. If it were being used at this rate, the current stock of kits available in the country would last 25 days.
To test for Covid-19, labs need to have several chemical elements: probes, primers and reagents. Read this for an explanation for how the kits actually work. According to the ICMR, the first step of the kit costs Rs 1,500 and the second confirmatory portion costs Rs 3,000 – although they are available for free for suspect cases at government labs.
On Tuesday, the ICMR said it had “already placed orders to augment the existing stockpile of reagents to 1 million tests which would be available soon. WHO [World Health Organisation] has also been requested to provide additional 1 million probes for testing.”
What about lab capacity?
While the supply of testing kits is a constraint, India does not have a shortage of testing labs, say experts. The ICMR has said it would expand the network of government labs testing for coronavirus to 72, adding 49 more labs by the month end.
Apart from government labs, many private labs in India have the equipment required to conduct the coronavirus tests. The ICMR has not roped them in yet, but on Tuesday issued new guidelines that prepare the ground for private sector involvement in testing.
The guidelines say that the ICMR is engaging with “high-quality private laboratories” including ones accredited by the National Accreditation Board for Testing and Calibration Laboratories to increase testing capability “while ensuring appropriate safeguards.”
Apart from quality control, one of the challenges in opening up coronavirus testing in private labs, said officials, is the need for traceability – the government must be able to trace those who test positive in the private labs.
One of the fears expressed by public health activists is that once private labs open, it could lead to unequal access to the tests. Severely ill patients with coronavirus symptoms might be able to get themselves tested in private labs, even if they do not have travel and contact history, provided they can pay for the tests. But those who cannot afford private tests will remain at the mercy of government labs, which follow a stricter testing criteria, public health activists fear.