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CONSUMERS PROTECTION ASSOCIATION, INDIA




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ICMR has issued Guidelines for use of commercial kits for nasal/throat swab based diagnosis of COVID-19 in India, 28 March, 2020





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March 28, 2020, 10:59 p.m.


 Currently, RT-PCR probes for diagnosis of COVID-19 are procured from USA by ICMR-NIV and are
distributed to the testing laboratories across the country
 ICMR welcomes use of commercial kits for diagnosis of COVID-19
 US FDA EUA/CE IVD approved kits can be used directly after due approval from DCGI and intimation to
ICMR
 ICMR has established a fast-track mechanism for validation of non US FDA EUA/CE IVD approved kits at
ICMR NIV. Test kits with 100% concordance among true positive and true negative samples will be
approved for commercial use in India
 ICMR NIV has completed evaluation of 17 non- US FDA EUA/CE IVD kits.