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The Indian Council of Medical Research (ICMR) is working relentlessly to implement scientific interventions to combat the SARS-CoV-2 (COVID-19) pandemic. The Council has expanded its capacity to diagnose and manage COVID-19.
ICMR has procured 10 lakh Reverse Transcription-Polymerase Chain Reaction (RT-PCR) kits used for diagnosis and 7 depots have been established for uninterrupted supply of reagents across the nation for efficient distribution to government testing laboratories.
New RT-PCR kits are being validated by 4 ICMR institutes for their use. Till now, 19 non-US FDA EUA/CE IVD real-time RT-PCR kits have been validated of which 05 have been recommended based on 100% concordance with positive and negative samples. The recommendations have 2 | P a g e been shared with the Central Drugs Standard Control Organisation(CDSCO) for taking it forward.
Apart from this, antibody-based tests have also been made available for sero-surveillance. However, antibody tests are not suitable to diagnose live COVID-19 infections. ICMR has released advisory to start rapid antibody based blood test for COVID-19 as a strategy for areas reporting clusters (containment zone) and in large migration gatherings/evacuees centres.
ICMR has validated and recommended 7 such test kits for use. In addition to this, all US-FDA/EU CE approved RT-PCR and antibody kits can be used for COVID19 diagnosis after approval from Drug Controller General of India (DCGI) and intimation to ICMR.
ICMR has validated and recommended TruenatTM beta CoV test on TruelabTM workstation as a screening test. All positives through this platform will need to be reconfirmed by confirmatory assays for SARS-CoV-2. All negatives may not be processed further. Currently, there are nearly 300 TruelabTM workstation already deployed in country and it will be utilized for the testing.
