Fast Track Approval for Indian COVID-19 testing kits for commercial use

This is in addition to the US FDA approved kits that are currently being in use

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.