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Kerala-based research centre gets marketing approval for coronavirus rapid testing kit

The centre, an autonomous institution under the central government's Department of Biotechnology, today said it has obtained marketing approval for an indigenous cost-effective Rapid Antibody Card that will help study the presence of anti-SARS-CoV-2 IgG antibodies, with 100 per cent sensitivity and 98 per cent specificity

twitter-logoJoe C Mathew | July 16, 2020 | Updated 20:03 IST
Kerala-based research centre gets marketing approval for coronavirus rapid testing kit
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Thiruvananthapuram-based Rajiv Gandhi Centre for Biotechnology (RGCB) has joined the fast growing set of homegrown institutions that are developing COVID-19 diagnostic tools.

The centre, an autonomous institution under the central government's Department of Biotechnology, today said it has obtained marketing approval for an indigenous cost-effective Rapid Antibody Card that will help study the presence of anti-SARS-CoV-2 IgG antibodies, with 100 per cent sensitivity and 98 per cent specificity. RGCB claims that the product is cost-effective, sensitive, and rapid, and facilitates testing of a large number of samples at any level of clinical setting, public health centres and hospitals.

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

These products have been developed by RGCB in partnership with Sperogenx Biosciences Pvt Ltd, Bengaluru, and POCT Services, New Delhi, under SARS-CoV-2 diagnostic umbrella. Of these, VTM and RNA kits have already been test-marketed. Sperogenx is the development partner and POCT the commercial partner.

The other products of RGCB--Antigen detection system, ELISA and PCR kits--are under various stages of approval from the regulatory authorities in India.

M. Radhakrishna Pillai, director, RCGB said that these products are a testimony of the institution's commitment to fight COVID-19 infection.

The VTM kit, formulated using raw material from Indian sources as per United States' Centre for Disease Control (CDC) 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 that is 30 to 35 per cent less, RGCB states.

Similarly, RGCB's RNA kit claims to facilitate fast manual isolation of viral RNA from the swab. "The process takes only 25 to 30 minutes to extract 95 per cent yield of RNA. It also has the price advantage as it is manufactured using raw material available in India," the centre states.

The RGCB is also collaborating with Sperogenx to develop a COVID-19 Real Time Multiplex RT-PCR Kit for qualitative detection of novel corona virus. This is also a fully indigenous product and has been submitted for final validation to International Centre for Medical Research and Training (ICMRT).

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