RGCB products get manufacturing licence

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The two other products of RGCB that have been granted licence by the Central Drugs Standard Control Organization (CDSO) are Viral Transport Media (VTM) kit and a viral RNA extraction kit.

The other products of RGCB — Antigen detection system, ELISA and PCR kits — are in various stages of approval.

A press note quoting Director, RGCB, M. Radhakrishna Pillai said the products were developed to help the government in the battle against COVID-19.

The Rapid Antibody Card will help study the presence of anti-SARS-CoV-2 IgG antibodies with 100% sensitivity and 98% specificity, and is cost-effective, sensitive, and rapid. It also facilitates testing of a large number of samples.

The VTM kit, formulated using raw material from Indian sources as per United States’ Centre for Disease Control guidelines, is suitable for collection, transportation, maintenance and long-term storage of viral specimens. It helps preserve the viability of viruses for up to 72 hours at refrigerated temperatures. The swabs have been designed ergonomically with a pre-moulded breakpoint on their shaft. Though there are similar products available, this kit can be marketed at a price 30 to 35% less.

The RNA kit facilitates fast manual isolation of viral RNA from the swab. The process takes only 25 to 30 minutes to extract 95% yield of RNA.

The RGCB, in collaboration with POCT, is also developing an affordable, easy-to-use ELISA kit.

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