Three kits including one by a Pune-based manufacturer have been approved by ICMR for COVID-19 testing.

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Coronavirus Coronavirus Wednesday, March 25, 2020 - 13:25

Amid concerns over a shortage of testing kits in the country, the Indian Council of Medical Research (ICMR) has recommended three COVID-19 test kits including one by a Pune-based company to be used by government and private testing facilities approved by ICMR. The three approved testing kits are Pune-based MY LAB, German-based Altona Diagnostics and Seegene, a South Korean company.  MY LAB is India’s first indigenous manufacturer to be approved for COVID-19 testing. 

According to a press statement on Tuesday, ICMR-NIV (National Institute of Virology), Pune has established a ‘fast-track’ mechanism for COVID-19 test kits, which have not been approved by US FDA EUA (United States Food and Drug Administration Emergency Use Authorization), or CE IVD (European authorisation for In Vitro Diagnostic devices). ICMR had earlier ordered hospitals and private labs to only use kits that were approved by the US FDA or European CE approval. 

So far, ICMR-NIV Pune has evaluated 14 such test kits, of which three kits (from Altona Diagnostics, MY LAB and Seegene) have been approved. These kits can be used directly, after due approval from DCGI (Drug Controller General of India), and intimation to ICMR.

Sharing the evaluation details of all 14 kits tested, ICMR said that only those test kits with “100% concordance among true positive and true negative samples” are being recommended. 

How are the kits evaluated 

Dr Jacob John, who formerly headed Indian Council for Medical Research’s (ICMR) Centre for Advanced Research in Virology, and Christian Medical College (CMC), Vellore professor emeritus, explains that the ‘concordance’, is the consistency of the results shown by a new test, when compared with a standard, approved test, called the ‘gold standard’. 

“New diagnostic tests will be compared to the gold standard test, so that when both tests are applied, samples that test positive by gold standard, must be positive for the new method. Similarly samples that are found to be negative by the gold standard test, must be found negative by the new test,” Dr Jacob John says. 

Apart from Altona, MY LAB and Seegene, most other tests have only shown 100% concordance for either true positive or true negative samples. “If a test shows 99% concordance and costs less, it can be used and the positives can be taken as positive, while the negatives may have to be tested again by another test. But this can only be done under research, not for clinical samples,”  he says. This means that a test which shows 100% concordance for true positive samples, is reliable when it shows a sample to be positive for coronavirus. But if the same test has less than 100% concordance for true negative samples, and it shows a sample to be negative, then the sample would have to be retested with a test kit with 100% concordance for negative samples, to confirm that the sample is indeed negative for coronavirus.

Will this increase testing capacity in private labs? 

As of Tuesday, 16 private labs across Indian were authorised to carry out tests for coronavirus. A Velumani, CEO of Thyrocare, one of the authorised private labs, says that these labs have so far been using test kits approved by US or European bodies. These kits have been in short supply, with restrictions on international flights posing a challenge in procurement. 

But the ICMR approval for Altona, MY LAB and Seegene is unlikely to make much difference to supply of test kits to private labs immediately, according to Velumani. Of the two companies, only the Pune-based MY LAB can manufacture in India. Velumani says, however, MY LAB does not have sufficient stock at present. “They have a local manufacturing facility, but they haven’t kept stock, as there would be no point unless there was government approval. Now that the government has approved, they want to manufacture. But manufacturing in a lockdown environment will be very challenging,” he says, adding that supply of locally manufactured kits may not speed up anytime soon. However, according to Thyrocare General Manager M Chandrasekar, MY LAB has promised to manufacture and supply up to 1.5 lakh tests in a week. 

Altona, on the other hand, is a German company importing from Europe and selling in India. But they also have limited stock, and there’s uncertainty around further import of test kits, Velumani says. Similarly, Seegene is a South Korean company which does not manufacture in India. “They have said that stock is in transit, but that will be subject to whether logistics are in place for dispatch, transport and landing,”  he says. Similarly,