Identity and stability assessment of BCG vaccine by multiplex PCR
Abstract
Multiplex polymerase chain reaction method was used to assess the stability of 7 seed lots of a substrain Mycobacterium bovis BCG-1, Russia, used for the manufacture of BCG vaccine since 1948 till present. For performng PCR we used primers, matching 5 parts of the RD field and 1part of repeating elements of intergenic operon senX3-regX3 region. Electrophoregrams of amplification products for 7 seed lots of products were identical and differed from the electrophoregrams of other known BCG substrains used as control samples. Similar results were obtained for genotyping of 32 commercial lots of BCG vaccine, manufactured using substrain M. bovis BCG-1 by three Russian manufacturers. The obtained data confirmed the stability of seed lots of BCG vaccine used for more than 60 years, and the adequacy of the settled system of strain maintanance. The assessed method of multiplex PCR with domestic reagents can accepted for confirming that the seed and the vaccine are identical to domestic BCG vaccine substrain (M. bovis BCG-1) when performing «Identification» test. The mehod is adequate and reproducible.
About the Authors
D. T. Levi
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Chief expert of Office of expertise of antibacterial medical immunobiological preparations of Center of expertise and control of medical immunobiological preparations. Doctor of Medical Sciences, professor
Russian Federation
Chief expert of Office of expertise of antibacterial medical immunobiological preparations of Center of expertise and control of medical immunobiological preparations. Doctor of Medical Sciences, professor
Yu. I. Obukhov
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Head of Office of expertise of antibacterial medical immunobiological preparations of Center of expertise and control of medical immunobiological preparations
Russian Federation
Head of Office of expertise of antibacterial medical immunobiological preparations of Center of expertise and control of medical immunobiological preparations
N. V. Aleksandrova
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Chief expert of Laboratory of bacterial vaccines of Test Center of Quality Expertise of medical immunobiological preparations. Candidate of Medical Sciences
Russian Federation
Chief expert of Laboratory of bacterial vaccines of Test Center of Quality Expertise of medical immunobiological preparations. Candidate of Medical Sciences
R. A. Volkova
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Head of the laboratory of molecular biology and genetic testing methods of Test Center of Quality Expertise of medical immunobiological preparations. Doctor of Biological Sciences
Russian Federation
Head of the laboratory of molecular biology and genetic testing methods of Test Center of Quality Expertise of medical immunobiological preparations. Doctor of Biological Sciences
E. V. Elbert
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Leading expert of the laboratory of molecular biology and genetic testing methods of Test Center of Quality Expertise of medical immunobiological preparations. Candidate of Biological Sciences
Russian Federation
Leading expert of the laboratory of molecular biology and genetic testing methods of Test Center of Quality Expertise of medical immunobiological preparations. Candidate of Biological Sciences
M. V. Alvarez Figeroa
Central Epidemiology Scientific and Research Institute
Russian Federation
Head of the research group to develop new methods for diagnosis of tuberculosis of department of molecular diagnostics and epidemiology. Candidate of Medical Sciences
Russian Federation
Head of the research group to develop new methods for diagnosis of tuberculosis of department of molecular diagnostics and epidemiology. Candidate of Medical Sciences
A. V. Prokopenko
Central Epidemiology Scientific and Research Institute
Russian Federation
Russian Federation
Junior researcher
R. I. Ludanniy
Central Epidemiology Scientific and Research Institute
Russian Federation
Leading researcher. Candidate of Biological Sciences
Russian Federation
Leading researcher. Candidate of Biological Sciences
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Review
For citations:
Levi D.T., Obukhov Yu.I., Aleksandrova N.V., Volkova R.A., Elbert E.V., Alvarez Figeroa M.V., Prokopenko A.V., Ludanniy R.I. Identity and stability assessment of BCG vaccine by multiplex PCR. BIOpreparations. Prevention, Diagnosis, Treatment. 2016;16(1):49-54. (In Russ.)
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