The Indian Council of Medical Research (ICMR) said it 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 per cent concordance among true positive and true negative samples.
The 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 per cent concordance among true positive and true negative samples have been recommended for commercial use in India, the statement said.
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.