Evaluate Risk Analysis of Measurement Uncertainty (MU) of Different Methods Applied for Veterinary Vaccines Evaluation

Elsawy, Hala; El Zieny, Amany; El Naggar, H.  M.; Rady, Doaa I.; Zaki, Eman S.A.; El Tahaan, Fouad

doi:10.21608/javs.2022.150328.1163

Evaluate Risk Analysis of Measurement Uncertainty (MU) of Different Methods Applied for Veterinary Vaccines Evaluation

Document Type : Original Article

Authors

¹ Department of Quality Control Lab (QCL) Veterinary Serum and Vaccine Research Institute (VSVRI), Abbasia, Cairo, Agricultural Research Center (ARC), Egypt

² Central Laboratory for Evaluation of Veterinary Biologics (CLEVB), Abbasia, Cairo, Agricultural Research Center (ARC), Egypt

10.21608/javs.2022.150328.1163

Abstract

Veterinary Serum and Vaccine Research Institute (VSVRI ) objected to producing highly efficient vaccines from reference or local isolates according to the international specifications for protecting animals and poultry against different diseases and preparing combined vaccines to save effort, time and money. VSVRI produces various types of vaccines such as live attenuated viral poultry, live attenuated viral animal vaccines, live attenuated Bacterial animal vaccines and Inactivated viral animal vaccines. These vaccines are subjected to quality assurance through seven methods with different techniques. Validity and measurement uncertainty for results were applied in the evaluation of results of the following: Titration of virus content using egg inoculation through Chorioallantoic Membrane (CAM), Intra-allantoic (IA) and Tissue Culture (TC). Determination of antibody titer using ELISA, HI and VNT techniques. Finally, enumeration of aerobic bacterial count for living attenuated Bacterial vaccine by culture technique. Homogeneity and stability results for all vaccines were accepted criteria according to TS/ ISO 22117. The reproducibility component of the TC technique was higher while the Bias was lower than other different routes of egg inoculation. In conclusion, the accuracy of TC technique is better than the egg inoculation technique which will reflect on the measurement of uncertainty. There is no significant change in the final measurement uncertainty of different routes of egg inoculation. In comparison, there is a variance between bias accuracy and reproducibility precision due to the equation of measurement of uncertainty depending on all processes performed in test accuracy and precession.

Keywords

Main Subjects

Immunology and Vaccinology

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