Fast Track Approval For Indian COVID-19 Testing Kits For Commercial Use

Posted by Admin on November, 24, 2021

New Delhi : ICMR has recommended two RT-PCR (Reverse transcription polymerase chain reaction) test kits for use in ICMR approved government and private laboratories. These test kits have been found to have 100% concordance among true positive and true negative samples. The details in annexure includes all the kits tests as on date.

ICMR has established a fast-track mechanism for validation of non-US FDA EUA/CE IVD approved kits at ICMR NIV Pune. ICMR NIV Pune has completed evaluation of 09 non-US FDA EUA/CE IVD kits. Only test kits with 100% concordance among true positive and true negative samples have been recommended for commercial use in India.

In addition to the above US FDA EUA/CE IVD approved kits can be used directly after due approval from DCGI and intimation to ICMR

This entry was posted on November, 24, 2021 at 17 : 03 pm and is filed under Biolab India. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response from your own site.

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