New Delhi: The Narendra Modi government will now allow “high quality” accredited private labs to conduct the tests of coronavirus samples to ramp up its COVID-19 testing capabilities.
Roche Diagnostics India — Indian subsidiary of Swiss multinational firm Roche — was on Tuesday accorded the test licence for SARS CoV-2 diagnostic test.
Dr Balaram Bhargava, Director General of Indian Council of Medical Research (ICMR), said Tuesday the labs that will be allowed to test coronavirus samples will include those accredited by the National Accreditation Board for Testing and Calibration of Laboratories (NABL).
This will help us understand [disease] modality, increase access to tests while ensuring appropriate safeguards, he added.
The private laboratories, which have procured reagents, can, meanwhile, also begin testing. Reagents are chemicals needed to test coronavirus.
“We will be delighted to have them onboard to test,” said Bhargava.
He added the ICMR would ask them to inform the Integrated Disease Surveillance Programme (IDSP) whenever they get positive samples.
However, private laboratories, who have been in regular touch with the government over the issue of coronavirus, said they have not received any communication regarding this.
They said testing of samples can only start once testing kits are validated by the government and the private labs receive the required authorisation from the government.
“We are yet to receive any notification in this regard,” said Dr Harsh Mahajan, founder of private lab Mahajan Imaging, and vice-president of NatHealth, a healthcare industry body.
India has reported 126 confirmed cases of COVID-19 with three deaths so far.
Currently, only those with symptoms and with a travel history or with a contact with those having a travel history are being tested for coronavirus.
Experts have said India’s relatively less number of coronavirus cases could be due to its restrictive testing protocol and it needs to increase its testing capabilities to find more cases.
49 more labs to be allowed to test for COVID-19
Currently, only 72 government-approved laboratories can test for COVID-19.
India has conducted about 11,500 tests so far using about 10 per cent of its capacity.
“As many as 49 more labs, which are not ICMR labs, but part of CSIR (Council of Scientific and Industrial Research), medical colleges, DRDO (Defence Research and Development Organisation) and DBT (Department of Biotechnology) network will be included by the end of this week,” said Bhargava.
The government has acquired two high ‘throughput systems’ (machines that can test 1,400 samples in a day) and they will be activated in two sites, he said.
The government has also ordered 10 lakh probes (chemicals needed to test coronavirus) to increase its testing capacity.
Labs, including private laboratories that can perform real-time polymerase chain reaction (PCR) tests, can also be used to test for coronavirus.
PCR tests are done in kits that require a primer and a probe to look at the DNA of the virus and identify it.
India has 60-70 NABL-accredited labs that are already testing for H1N1 and these labs can be roped in for COVID-19 testing too, said Navin Dang, director of Dang’s Lab, a Delhi-based chain of diagnostic laboratories.
Help from private players
Currently, private laboratories do not have the kit validated by the government to start testing.
“At the moment, four vendors have been waiting for National Institute of Virology’s validation for conducting the test,” said Dang.
Dang said that some players in the private sector have the equipment, the trained manpower and the knowledge to conduct the tests but they cannot start the process unless the government validates the kits and decides the methodology.
This process would take a few days, he said.
While Swiss company Roche’s testing kit has got the government nod, South Korea’s Seegene have been waiting for NIV’s validation.
Roche has received US Food and Drug Administration (FDA) Emergency Use Authorisation and has started shipping 4,00,000 kits to the US for testing.
Private laboratories can help collect samples from home, reduce the time for the results to come and increase access to the test to all those who are eligible under the current guidelines, Mahajan from NatHealth said.
Representatives of laboratories, industry bodies like the FICCI and NatHealth, had even met Union Health Minister Harsh Vardhan and the Union health secretary a week ago, asking to be added to the government’s diagnostic capacity.
“We had even suggested that the government can bulk purchase the reagents and then route it through the private sector,” said Mahajan, adding it could have led to reduced prices.
No to free testing
The government’s request for free testing, meanwhile, has not been received well.
“We cannot do the tests for free, we will get a huge demand and will have to close shop,” said an owner of a diagnostic chain.
Had the government provided testing kits and samples, we would have pooled our corporate social responsibility funds and done the tests for free, said Ameera Shah, managing director of Metropolis lab, a diagnostic chain, adding that it cannot do it without that support.
“We suggest the government fixes a reasonable MRP along with us where patients who want to screen and pay for their test, have the option to come to selected private labs and patients who want a free test can continue going to government labs,” she said.
She further said some companies can use their CSR funds to donate to the ICMR if it expands its testing facility to private labs for large-scale screening.
There is no need for wider testing since India is still in the second stage of transmission where the infection is limited to contacts of those with travel history, ICMR scientists had said.
However, even under the current testing protocol, testing centres have been overwhelmed by patient numbers. At Kasturba Hospital, Mumbai’s only centre for coronavirus testing, only 100 samples can be processed in a day.
“Suspected COVID-19 (patients) have to wait an average of 3 hours to get tested. If the centre has already collected 100 samples, they send the person back,” said Deepak Baid, president-elect, Association of Medical Consultants, adding that it increases the risk of exposure to others waiting with them and also their family members when they go back without testing.
No testing if no symptoms
The ICMR Tuesday changed testing protocols and suggested that individuals should home-quarantine themselves for 14 days if they had a direct and close physical contact with laboratory-confirmed positive case patients or had a history of travel in last 14 days to high risk COVID-19-affected countries.
If they develop symptoms like fever, cough and difficulty in breathing, they should contact the helplines for testing but if they are asymptomatic, they do not require a laboratory test.
The protocol was updated to include testing for healthcare workers who have acute respiratory illness after caring for those with severe respiratory illnesses patients.