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Dear Readers,Welcome to the latest issue of The Magazine
Delhi based Oscar Medicare Pvt. Ltd., manufacturer of various in-vitro diagnostic kits, has developed a rapid test for detection of COVID antibody using recombinant proteins of 100% Indian origin in collaboration with Dhiti Life Sciences Pvt. Ltd. (DLSPL). The product has been validated and approved by ICMR lab-National Institute of Virology-Pune. As per ICMR report, OSCAR CORONA Antibody test has sensitivity of more than 97% and specificity of 99%.
DLPLS is engaged in the R&D and manufacturing of recombinant proteins and monoclonal antibodies used in the IVD kits. The recombinant protein of Corona virus was developed by the scientific team under guidance of Dr. Abhinav Shrestha, a young scientist and Ph.D
from National Institute of Immunology-Delhi, told that developmental work of recombinant protein of COVID-19 was initiated in month of April-May 2020 looking dependency of the active raw material on foreign suppliers and urgent need of country to support the vision of the Govt. of India “Atmanirbhar Bharat’. Being a DSIR approved biotechnology lab, it was easy for the team Dhiti Life Science to approach Dept of Biotechnology (DBT), BIRAC and other Govt agencies including THSTI for support in the development of 100% Indian test.
Dhiti Life Sciences has received BIRAC grant under their COVID-19 call for the project titled as “Development of Lateral flow test for the detection of anti-corona virus SARS-COV-2 specific IgG & IgM from human sera”. Under the same project above antigen and hence fully indigenous lateral flow device has been developed in collaboration with Oscar Medicare Pvt. Ltd.
THSTI (Translational Health Science and Technology Institute-An AN AUTONOMOUS INSTITUTE OF DEPT. OF BIOTECHNOLOGY, MINISTRY OF SCIENCE AND TECHNOLOGY, GOVT OF INDIA) has provided the COVID-19 validated positive serum samples for the internal development and quality control of the developed rapid test). The support of THSTI is highly appreciable the in the process of rapid test.
Mr. Umesh Kaushik, Director-Technical of Oscar Medicare said that being a manufacturer of various IVD tests kits, it was very easy to receive a test license permission on MD-13 from the Drugs Controller General of India for Corona Antibody Rapid test kits, a move that takes it one step closer to the launching them in Indian market as per guidelines of the Govt of India. Oscar Medicare immediately started the developmental work of COVID-19 antibody on high priority.
Mr. Umesh Kaushik, Director-Technical said that developed Oscar COVID Antibody test is a rapid test kit which is quite simple to use and perform the even at bed side of the patient or at home. A small drop of whole blood or Serum / plasma is sufficient to perform the tests and visual results can be obtained within 5 to 20 minutes in the patient sample. It is a qualitative test which provides the information that whether suspected person has
developed antibodies or not. The test is quite simple to perform in any general healthcare facilities without needs of specialized laboratory technologist and additional equipment. The kit is very stable at room temperature and its storage and transportation will not be an issue as per Indian climate.
Dr. Arvind Saxena, Director- R&D, updated that antibodies are developed in any individual within 7-14 days of COVID-19 infection. IgM type antibodies are generated first and appears in the body after infection, the presence of IgM antibody in the patient specimen directly indicates the current infection of COVID-19 (Corona Virus). The shelf life of the IgM antibodies is exceedingly small and remain for a shorter period in the blood circulation. Another type of antibodies which is IgG, it develops and appears in the body on later stage of infection and remains in the blood circulation for longer time. The Presence of IgG antibodies also indicates that immunity has developed for the COVID-19.
Dr. Savita Sekhri, Head-QA, updated that validation and performance evaluation of the developed product is done at the specified centers as per guidelines of Govt of India before commercial launch of the product. Our CORONA antibody Rapid Test meets desired sensitivity and specificity as per guidelines of ICMR and it happened only due to incorporation of 100% Indian & highly specific recombinant protein of COVID-19 in the test formulation.
Mr. Anand Sekhri, Group CEO of Oscar Medicare Group of companies appreciated to the regulatory agencies DCGI, ICMR, BDT, BIRAC, THSTI and NIV-Pune for the cooperation, prompt approvals & validations of the product of 100% Indian origin. Oscar has enough capacity and capabilities to produce bulk quantities of tests if required to Govt agencies for the mass screening. The product will be available in the market very soon only after regulatory approvals from DCGI for the commercial manufacturing and marketing of the product. He added that our entire team is ready to serve the Nation in the ongoing crisis of COVID-19 by way of providing diagnostic tests. Mr. Sekhri updated that we are committed to the society and will donate 1.0 lac tests of COVID Antibody tests to Govt of India / ICMR.
Among the few manufacturer of rapid tests kits in Delhi NCR, Oscar is the first company to develop and validate the product with recombinant proteins of 100% Indian origin. Our COVID antigen rapid test is also under validation from ICMR and hopefully it will be cleared soon with the set criteria of the validation by the ICMR.
For any clarification feel free to contact :
Mr. Umesh Kaushik
[email protected]
