Indian Council of Medical Research (ICMR) has validated Department of Scientific & Industrial Research (DSIR) accredited an ISO 13485 certified biotech reagent manufacturing organisation based in West Bengal for producing SARS-Cov-2 viral RNA detection kit named DiAGSure nCOV-19 Detection Assay to meet the diagnostic testing challenges the country is facing right now. The kit was validated by ICMR on May 1, 2020 and is mentioned in the website of ICMR. ICMR approved the kit possessing the Batch Number 20115K1278 & 20115K1251 developed by GCC Biotech (India) Pvt Ltd, the company based in Bakrahat, South 24 Parganas, West Bengal. The price tag of the kit is Rs 500 and has demonstrated a near about 100% sensitivity as well as specificity in detecting the virus within a short span of 90 minutes (testing time). This apart, the strategically designed primers used for detecting the viral nucleic acid, the test promises to cover for possible variations in viral strain character limiting the chances of false-negative results. The kit is capable of detecting the virus at an extremely low viral load or titer even at the very early stages of the viral infection.
This has become possible largely due to the unflinching efforts of a young group of scientists who toiled day and night to ensure that every component of this kit is indigenously developed. This not only helped to bring down its cost and ensure its affordability for the millions who need the test today but also to do without the dependence on import of kit components (which are also costly) during these uncertain times.
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