Certification and potential future use of the reference standard designed for the test system for determination of the fractional (antigenic) composition of human serum products by immunoelectrophoresis
Abstract
The article gives an account of certification performed for a new batch of a Reference standard to be used with the test system for determination of the fractional (antigenic) composition of human serum products by immunoelectrophoresis -industry reference standard (IRS) 42-28-77 - in accordance with existing requirements. A candidate reference standard was represented by a batch of normal human serum intended for diagnostic purposes (more than 500 donors) and a batch of immunoelectrophoresis serum against human serum proteins (antiserum against human serum proteins). In accordance with the certification programme, the fractional (antigenic) composition of the reference standard was determined by immunoelectrophoresis using «KliniTest-EF» buffer and 0.05 M borate buffer solution and the modes stipulated in the general monograph 1.8.2.0002.15 Agar gel immunoelectrophoresis. The reaction between the antiserum against human serum proteins and the normal human serum components of the reference standard produced at least 15 precipitation lines. The study demonstrated that the bromphenol blue dye could be used together with «KliniTest-EF» buffer to assess albumin migration, and the pyronin B dye could be used together with «KliniTest-EF» buffer and 0.05 M borate buffer solution to assess immunoglobulin migration. The study confirmed the applicability of the certified reference standard designed for the test system for determination of the fractional (antigenic) composition of human serum products by immunoelectrophoresis, and set the criteria for its use in the context of human serum products identification (species specificity) testing not only by immunoelectrophoresis, but also by agar-gel immunodiffusion.
Keywords
стандартный образец тест-системы для определения фракционного (антигенного) состава,
препараты крови,
препараты иммуноглобулинов человека,
иммуноэлектрофорез,
иммунодиффузия,
подлинность (видоспецифичность),
буферный раствор,
краситель,
blood products,
human immunoglobulin products,
immunoelectrophoresis,
immunodiffusion,
identification (species specificity),
buffer solution,
dye
About the Authors
O. G. Kornilova
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Chief expert of the Laboratory of Immunoglobulins and Blood Products of the Testing Centre for Evaluation of Medicinal Immunobiological Products’ Quality. Candidate of Medical Sciences
Russian Federation
Chief expert of the Laboratory of Immunoglobulins and Blood Products of the Testing Centre for Evaluation of Medicinal Immunobiological Products’ Quality. Candidate of Medical Sciences
I. L. Arefyeva
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Senior microbiologist of the Laboratory of Immunoglobulins and Blood Products of the Testing Centre for Evaluation of Medicinal Immunobiological Products’ Quality
Russian Federation
Senior microbiologist of the Laboratory of Immunoglobulins and Blood Products of the Testing Centre for Evaluation of Medicinal Immunobiological Products’ Quality
E. S. Konovalova
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Engineering technician of the Laboratory of Immunoglobulins and Blood Products of the Testing Centre for Evaluation of Medicinal Immunobiological Products’ Quality
Russian Federation
Engineering technician of the Laboratory of Immunoglobulins and Blood Products of the Testing Centre for Evaluation of Medicinal Immunobiological Products’ Quality
R. A. Volkova
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Head of the Laboratory of Molecular Biology and Genetic Test Methods of the Testing Centre for Evaluation of Medicinal Immunobiological Products’ Quality. Doctor of Biological Sciences
Russian Federation
Head of the Laboratory of Molecular Biology and Genetic Test Methods of the Testing Centre for Evaluation of Medicinal Immunobiological Products’ Quality. Doctor of Biological Sciences
O. V. Fadeykina
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Chief technologist of the Testing Centre for Evaluation of Medicinal Immunobiological Products’ Quality. Candidate of Biological Sciences
Russian Federation
Chief technologist of the Testing Centre for Evaluation of Medicinal Immunobiological Products’ Quality. Candidate of Biological Sciences
E. Yu. Kudasheva
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Head of the Laboratory of Immunoglobulins and Blood Products of the Testing Centre for Evaluation of Medicinal Immunobiological Products’ Quality. Candidate of Medical Sciences
Russian Federation
Head of the Laboratory of Immunoglobulins and Blood Products of the Testing Centre for Evaluation of Medicinal Immunobiological Products’ Quality. Candidate of Medical Sciences
A. A. Movsesyants
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Head of the Testing Centre for Evaluation of Medicinal Immunobiological Products’ Quality. Doctor of Medical Sciences, Professor
Russian Federation
Head of the Testing Centre for Evaluation of Medicinal Immunobiological Products’ Quality. Doctor of Medical Sciences, Professor
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Review
For citations:
Kornilova O.G., Arefyeva I.L., Konovalova E.S., Volkova R.A., Fadeykina O.V., Kudasheva E.Yu., Movsesyants A.A. Certification and potential future use of the reference standard designed for the test system for determination of the fractional (antigenic) composition of human serum products by immunoelectrophoresis. BIOpreparations. Prevention, Diagnosis, Treatment. 2017;17(2):116-121. (In Russ.)
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