Coronavirus Testing: ICMR Sets Up Fast Track Mechanism To Validate Kits That Don’t Have U.S. FDA, EU Approvals
The test kits have been found to have 100 percent concordance among true positive and true negative samples.
The Indian Council of Medical Research said it has recommended two 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 percent concordance among true positive and true negative samples.
The ICMR has established a fast-track mechanism for validation of non-U.S. Food and Drug Administration Emergency Use Authorisation/CE IVD approved kits at ICMR NIV Pune.
India Issues Guidelines For Private Testing, Ropes In National Labs As Coronavirus Cases Increase
ICMR NIV Pune has completed evaluation of 09 non-U.S. FDA EUA/CE IVD kits. Only test kits with 100 percent concordance among true positive and true negative samples have been recommended for commercial use in India, the statement said.
In addition, U.S. FDA EUA/CE IVD approved kits can be used directly after due approval from DCGI and intimation to ICMR.