The council evaluated 14 test kits out of which only three test kits were chosen. The three test kits give 100 per cent concordance among true positive and true negative samples
The Indian Council of Medical Research (ICMR) completed an evaluation of 14 non- US FDA EUA/CE IVD test kits for the novel coronavirus ( Covid-19) and approved only three test kits to use in the ICMR approved government and private laboratories.
The ICMR has established a fast-track mechanism for validation of non-US FDA EUA/CE IVD approved kits at the ICMR’s National Institute of Virology (NIV) Pune. And it has given approval to those kits which give 100 per cent concordance among true positive and true negative samples.
Three kits which have received the approvals are Mylab Discovery’s Patho Detect, Altona Diagnostics’s RealStar SARS-CoV-2 RT-PCR kit 1.0 and Seegene’s single-tube assay, Allplex.
According to ICMR the following have not received the approval:
- BGI’s Real Time Fluorescent RT-PCR Kit for detecting nCov 2019 gives 100 per cent concordance among true positive and 90 per cent concordance among true negative.
- Krishgen Bio System’SARS-CoV-2 Coronavirus Real-Time RT-PCR (RTqPCR) Detection Kit v1 also gives 100 per cent concordance among true positive and 80 per cent concordance among true negative.
- ABI’s TaqMan 2019-nCoV Control Kit v1 gives 100 per cent concordance among true positive and 90 per cent concordance among true negative.
- HIMEDIA’s Hi –PCR Corona Virus (CoViD-19) Probe PCR Kit gives 100 per cent concordance among true positive and 5 per cent concordance among true negative
- HUWEL’s Quantiplus Coronavirus (2019nCoV) detection kit gives 100 per cent concordance among true positive and 40 per cent concordance among true negative,
- IIT-Delhi’s SYBR Green-based one step QRT-PCR gives 98 per cent concordance among true positive and 10 per cent concordance among true negative.
- KILPEST’s (BLACKBIO) TRUPCR gives 100 per cent concordance among true positive and 75 per cent concordance among true negative
- Genesig’s Coronavirus (COVID19) genesig Real Time PCR Assay gives 100 per cent concordance among true positive and 84 per cent concordance among true negative
- Roche’s three kits LightMix Modular SARS and Wuhan CoV E gene gives 91 per cent concordance among true positive and 100 per cent concordance among true negative,
- LightMix Modular SARS and Wuhan CoV N gene give 93 per cent concordance among true positive 67 per cent concordance among true negative and LightMix Modular Wuhan RdRp gene gives 100 per cent concordance among true positives and 60 per cent concordance among true negative.
Mylab Discovery Solutions is the first to develop ‘Made in India’ test kit for Coronavirus.
Dr Lokesh Sharma, Scientist E, ICMR said, “The ICMR has established a fast-track mechanism for validation of non US FDA EUA/CE IVD approved kits at ICMR NIV. And welcomes the use of commercial kits for diagnosis of Covid-19. These test kits with 100 per cent concordance among true positive and true negative samples will be approved for commercial use in India.”
Currently, RT-PCR tests for diagnosis of COVID-19 are procured from the US by the ICMR-NIV and are distributed to the testing laboratories across the country.
The US FDA EUA/CE IVD approved kits can be used directly after due approval from DCGI and intimation to ICMR.