'The more people get tested, the more people will come under isolation. So the spread will get limited with testing.'.
Despite the World Health Organisation calling for more tests to curtail the spread of coronavirus, a test that can determine COVID-19 positive cases in six to eight hours seems to be stuck in a bureaucratic back and forth between the central health ministry and the Brihanmumbai Muncipal Corporation.
"ICMR (Indian Council of Medical Research) came back saying that only the local civic body has the authority to give approvals and that will be guided by the Union health ministry. When they (Union health ministry) give approval, the local civic body, which in our case is the BMC, will give approval," says Dr Arunima Patel, partner, iGenetics Diagnostics, a Mumbai-based testing laboratory, which claims that its PCR-based testing can detect a COVID-19 positive test in six to eight hours.
Dr Patel tells Prasanna D Zore/Rediff.com,/strong> what the PCR test is about, how they validated this test and why the BMC is likely to give approvals to all accredited labs to conduct COVID-19 tests.
You successfully validated COVID-19 tests almost a month-and-a-half back?
We have submitted our enabling application and all the test details to the BMC at the Kasturba hospital.
What exactly is this validation test and how effective are the test results?
This is a real-time PCR (Polymerase Chain Reaction) test. It is a highly sensitive test and the run time is six to eight hours; you can tell whether the person has infection or not in six to eight hours.
We are using CDC guidelines for doing this test.
CDC is the Centre for Disease Control, a US-based government body which issues guidelines for how can you test, how to collect samples, what strains to check for a particular virus, what strains to check while testing for COVID-19 virus.
How did you happen to have this test validated one month before? Then there was not such a big scare about COVID-19.
We knew that this virus may spread and that's why we got ourselves ready for the testing.
Do you need permission from the Indian Council of Medical Research to provide this service for testing COVID-19 positive cases?
ICMR's permission is needed only for kit manufacturers and we are not kit manufacturers.
We are a services company like a Metropolis or Dr Lal's Pathlab. We are doing this test based on approved protocols on very high class machinery.
iGenetics is an old name in infection detection. In fact, we have hundred plus tests that we do for testing various infections for five years now.
We have been doing a lot of R&D-related work for five years or so. And these tests have been developed based on CDC protocols using the primer and probe information that CDC and WHO have published.
Have you tested any COVID-19 positive patient using this test?
We have not yet been given approval by the BMC; we have validated this test using the positive controls which we brought from outside of India.
What happens is you get a positive control (a sample that contains the coronavirus), which is also provided by the CDC; they provide you a positive sample, and then you test your method to detect if the given sample is positive or not.
So six to eight hours is maximum you will need to determine if a person is infected with coronavirus instead of 36 hours that the National Institute of Virology, Pune takes now?
NIV, Pune, also uses the same technology (PCR). They also use real time PCR technology, but their challenge is the limitation of infrastructure. The number of PCR machines that they have and the number of samples they are testing.
If the BMC gives permission, how many people can you test in a day using the PCR test?
We are getting ready to test 500 patients a day.
Why hasn't the BMC given you permission yet?
They have not given permission to anybody, actually. But now they are talking about giving permission to any accredited lab and we are one of them. We have five labs in our system, which have submitted the applications to conduct the COVID-19 tests.
When did you validate this test before the BMC?
We have done this validation a month-and-a-half back.
We submitted our application to the BMC a month-and-a-half back, including what protocols we are using for waste disposal, for processing of the sample, for protection of the people when they collect and process the samples. We have shared all this protocol information with the BMC.
What was the BMC's response when you submitted your application one and a half month ago?
They have kept our application, but I think they are guided by what the Centre will say. They say when the Centre gives approval, the BMC will give approval.
So the approval needs to come from the Union health ministry.
Absolutely, absolutely. That's how the situation is currently.
So has the BMC sent your application to the Union health ministry?
No, the Union health ministry is not taking any applications directly; according to them the local civic body is where you need to submit your application.
ICMR came back saying that only local civic body has the authority to give approvals and that will be guided by the Union health ministry.
When they give approval, the local civic body, which in our case is the BMC, will give approval.
So as of now your application is stuck?
They (the Union health ministry) have to take a decision. Now they are waiting for it to become a big issue...
Hasn't the spread already assumed epidemic proportions?
It already has and better to test now.
The more people get tested, the more people will come under isolation. So the spread will get limited with testing.