Explainer: The How & What COVID-19 testing in India
Sai Krishna Muthyanolla
March 31, 2020
Close to 50 private labs are now authorized to conduct COVID-19 tests. But how are samples collected and tests conducted for COVID-19? Here is a detailed explainer.
As India enters the second week of lockdown, more than 1200 cases ofCOVID-19 have been reported across the country including 32 deaths, accordingto the Ministry of Health’s dashboard as of 9.30 PM on 30 March 2020.
The rapid spread of disease across the globe has challenged the healthcare systems of many countries. In an earlier story by Factly, it was observed that testing in India was low as compared to other countries which could be one of the reasons for a proportionately lower number of cases reported in India. In order to boost testing, the Indian Council of Medical Research (ICMR) which is India’s apex biomedical research body, has started approving private labs who are now authorized to carry out testing in addition to the government labs.
Private labs are being given approval to conduct
COVID-19 diagnosis tests
As on 30 March 2020, ICMR had given approval to 49 private laboratories who can conduct COVID-19 diagnosis tests.  This includes 10 laboratories in Maharashtra,8 each in Delhi and Telangana, 6 in Tamil Nadu, 5 in Haryana, 4 in Gujarat, 2each in Karnataka, West Bengal and Kerala and 1 each in Odisha and UttarPradesh. This is in addition to the 123 government laboratories which have been approved and supported by ICMR as on 30March 2020. Thus, in total, so far, more than 170 labs have been given approvalby ICMR for testing people for COVID-19.
However, the number of approved laboratories for COVID-19 testing isbound to increase in the coming days as more laboratories apply for permissionand the availability of testing kits improves.
It has to be noted that  private labs are not allowed to conduct tests for COVID-19 withoutthe approval of ICMR. Only those private laboratories which hold NationalAccreditation Board (NAB) for Testing and Calibration Laboratories’accreditation for real time Polymerase Chain Reaction (PCR) testing for RNAvirus and also possess all testing material will be given approval by ICMR. Thestructure of the coronavirus would be shared by ICMR once the approval is provided.
The following details must be sent to ICMR, by laboratories interested toperform COVID-19 diagnosis tests in order to get approval. The details include location,number of collection sites, available materials and machines, accreditationscope, and cost for test.
Who must get themselves tested?
In the beginning, the government had a testing strategy which included testing mostly the those individualswith history of foreign travel. This included asymptomatic individuals withhistory of foreign travel only if they show symptoms. Also included in thetesting pool were contacts of the laboratory confirmed positive cases.
On 20 March 2020, the government modified the testing strategy. As ofnow, the government has restricted tests to only symptomatic individuals who
Further, those asymptomatic persons who are in the high-risk category orhave had direct contact with those tested positive, must be tested after almostone week since the contact was made.
What sample is collected?
Samples are collected from people who are supposed to get tested. Accordingto World Health Organization and US Centers for Disease Control and Prevention (CDC), the following are the respiratory samples thatneed to be collected for COVID-19 diagnosis tests. It is mandatory thatbiosafety and biosecurity precautions are taken for sample collection.
From the lower respiratory tract,
From the upper respiratory tract,
In addition to these, blood sample can also be collected for testing forvirus. Furthermore, urine, stool, and even material from autopsy in case of deadpersons are collected for tests and research.
ICMR recommends private laboratories to collect samples fromsuspected persons at their homes since this helps in reducing human contactwhile travelling and in collection centers. Further, at the time of samplecollection, the government ID proof of residence and contact details of thesuspected patient is also collected.
What happens to the collected samples?
Up on ensuring that the collected samples are properly packed takinginto consideration the required precautions as the virus is highly contagious,the sample must be safely transported to the approved lab for testing.
For the detection of viral infections, there are two types of tests thatare mainly performed- one is genetic and the other is serological. Genetictests are used to identify infections which are currently active in the samplewhereas serological tests can also help trace past infections. PCR Test,abbreviation for Polymerase Chain Reaction Test, is a genetic test that isperformed to identify the presence of SARS-CoV-2 virus. For this, the RNA invirus is converted to DNA by the process of PCR. Reverse TranscriptasePolymerase Chain Reaction or RT PCR Test is also performed for qualitativestudy of gene expression. In short, there are two tests performed, one which looksat all the coronaviruses present and the other which looks for only SARS-CoV-2.
It should be noted that only those US FDA EUA/CE IVD approved kits whichhave been approved by DCGI and notified to ICMR should be used. ICMR has also established fast-track mechanism for non-US FDA EUA/CE IVD approvedkits.
What happens once tests are done?
All labs must send the samples of those tested positive to the National Instituteof Virology, Pune strictly adhering to the biosecurity and biosafetyprecautions. The negative samples must be destroyed within a week ofcollection. All biomedical waste produced must be disposed of carefully as perthe Biomedical waste management rules, 2016. The samples must be discarded, and swabs should bein sealed biohazard bag that contains 2% Lyzol or 5% freshly preparedhypochlorite solution.
No sample should be shared with other organizations. It is also illegalto culture the virus from the sample or use the same for other purposes. Thishas been strictly prohibited and any violation will result in legal action.
What is the cost for testing?
While ICMR recommends that the sample testing should be done for free orat a subsidized rate, the cost of test has been capped at Rs. 1,500 forscreening suspected cases and Rs. 3000 for confirmation test. That is, themaximum price for testing samples should not exceed Rs. 4,500 as per therecommendations of National Task Force.
One should note that the details given in the story are as per the latest details available as on 30 March 2020. The guidelines and protocols may undergo changes based on the severity of the pandemic in India.
Featured Image: COVID-19 testing in India