Veterynarna biotehnologija – Veterinary biotechnology, 2018, 32(1), 436-441 [in Ukrainian]. https://doi.org/10.31073/vet_biotech32(1)-58
BLOTSKA O., e-mail: This email address is being protected from spambots. You need JavaScript enabled to view it., GOLOVKO A., e-mail: This email address is being protected from spambots. You need JavaScript enabled to view it., RODINA Y., e-mail: This email address is being protected from spambots. You need JavaScript enabled to view it.
State Scientific Control Institute of Biotechnology and strains (DNKIBSHM)
STANDARDIZATION OF MEANS FOR SEROLOGICAL DIAGNOSIS OF ENZOOTIC BOVINE LEUCOSIS
The article presents the results of work on the standardization of approaches to quality control of test systems designed for serological diagnosis of Enzootic Bovine Leukosis. In the State Scientific Control Institute of Biotechnology and Strains of Microorganisms, in accordance with international norms and regulations, a National Standard of serums has been developed, which is used in controlling the quality of diagnostic test kits.
Introduction. Enzootic Bovine Leucosis (EBL) – is a chronic contagious disease of tumor origin, caused by the RNA-genomic oncogenic virus. EBL is registered in many countries of the world, also in Ukraine. Methodological approaches to the study of the epizootic situation of EBL provide in vivo diagnosis, based on the detection of antibodies. In order to do diagnostic work accurately and objectively it is obligatory to have qualitative specific and sensitive diagnostic kits. World practice of diagnostic products and quality control foresee the obligatory use of International or National Standards (NS).
The purpose of the work. Develop and implement the NS of serums, intended to standardize the means of serological diagnostics of the EBL, in order to unify and harmonize the methods for controlling in accordance with international regulations and norms.
Materials and methods of research. We used panel of 16 lyophilized samples of blood serums from the International Reference Laboratory of EBL, which included: positive, weakly positive, negative, false positive and false negative samples of blood serum and reference standard of positive serum. Reactions were conducted according to the classic methods. The validations of NS were conducted in OIE Reference Laboratory for EBL.
Results of research and discussion. We have developed the technology of manufacturing and have prepared NS for EBL, that consists of freeze-dried positive (weak-positive in dilution 1:10 in AGID) and negative serums. We have examining NS for EBL and obtained positive assessment in OIE Reference Laboratory, that was classified as being fully in line with International requirements. Now in order to verification the quality of commercial EBL test kits we are always using the National Standard serums. This allows to accurately and objectively assessing the quality of diagnostic means.
Conclusions. In accordance with international norms and regulations has been developed National Standard of serums, which is used in controlling the quality of diagnostic test kits.
Keywords: Enzootic Bovine Leukosis, laboratory diagnosis, standardization, quality control, agar gel immunodiffusion test.
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