South Korean agency’s testing equipment will get NIV’s validation to be used in India

The diagnostic kit manufactured by the South Korean Biotech firm, Seegene has been validated by National Institute of Virology (NIV), Pune to test the increasing number of suspected COVID-19 cases in the country.
The government has speeded-up the process of evaluating new testing kits made by Indian manufactures and those from other countries, which have not yet been approved by US-Food and Drug Administration (FDA) or EUA-CE (European) by setting up a fast-track mechanism at NIV-Pune.
It has so far has completed evaluation of 14 testing kits out of which three testing kits showed 100% results and have been validated by the lab and can now be used by ICMR recommended government and private laboratories across the country
This includes two testing kits one from Germany based Altona Diagnostics and the other from Maharashtra based MyLab. Both tests are based on real time PCR technology, recommended by World Health Organization (WHO) to confirm COVID-19 among people.
The PathoDetect developed by MyLab can screen upto 24 samples in a single run and provide results within two hours, against the current RT-PCR assay which give results for 90 samples within 6-7 hours.
The third testing kit to show 100% results was Seegene kit-Allplex 2019-nCoV Assay, which has been given a go-ahead by NIV. The diagnostic kit was granted an urgent-use licence in South Korea, just before the outbreak began sweeping the country and helped it to ramp up its testing facilities.
South Korea has garnered international praise for recording one of the highest rate of testing by any country. According to Seegene Inc, the kit is developed using Artificial Intelligence and take around four hours to provide results. It is however yet to be approved by US-FDA.
“We have recommended these results to the Central Drugs Standard Control Organization (CDSCO). Tests which give 100% results will only be approved for commercial use in India,” said an ICMR official.
This is in addition to the US FDA approved kits which can be used directly after due approval from Drug Controller General of India.
As of Wednesday, 119 government laboratories and 29 private laboratories have been given the go ahead to conduct testing by Indian Council of Medical Research (ICMR). These private laboratories have 16,000 collection centers across the country.
“As far as testing is concerned, it is being done free of cost in government laboratories. But we have included private laboratories to ensure wider availability of test and implemented price capping, so that these tests are not being done at exorbitant rates. We have also directed them to ensure availability of all reagents and probes. We have the capacity to do 12,000 tests every-day,” said Joint Health Secretary, Luv Aggarwal.

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