24 March 2020 | News
This is in addition to the US FDA approved kits that are currently being in use
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Indian Council of Medical Research (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.
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 9 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.
List of testing kits-
Altona Diagnostics - RealStar SARS-CoV-2 RT-PCR kit
MY LAB - Patho Detect
BGI - Real Time detecting 2019-nCoV
Krishgen Bio System - SARS-CoV-2 (RT-qPCR) Detection
ABI - TaqMan 2019-nCoV Control Kit
HIMEDIA - Hi –PCR Corona Virus (CoViD-19) Probe PCR
HUWEL - Quantiplus detection kit
IIT-Delhi SYBR Green based one step QRT-PCR
KILPEST (BLACKBIO) - TRUPCR