Evaluate Risk Analysis of Measurement Uncertainty (MU) of Different Methods Applied for Veterinary Vaccines Evaluation | ||||
| Journal of Applied Veterinary Sciences | ||||
| Article 7, Volume 7, Issue 4, October 2022, Page 44-54 PDF (1.29 MB) | ||||
| Document Type: Original Article | ||||
| DOI: 10.21608/javs.2022.150328.1163 | ||||
 View on SCiNiTO | ||||
| Authors | ||||
Hala Elsawy1; Amany El Zieny1; H. M. El Naggar  1; Doaa I. Rady1; Eman S.A. Zaki1; Fouad El tahaan2
| ||||
| 1Department of Quality Control Lab (QCL) Veterinary Serum and Vaccine Research Institute (VSVRI), Abbasia, Cairo, Agricultural Research Center (ARC), Egypt | ||||
| 2Central Laboratory for Evaluation of Veterinary Biologics (CLEVB), Abbasia, Cairo, Agricultural Research Center (ARC), Egypt | ||||
| 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 | ||||
| Bias accuracy and reproducibility precision; Measurement uncertainty; Vaccine | ||||
| References | ||||
|
BRUNO, A., WALTHER, B.A., and MOORE, J. L., 2005. The concepts of Bias, precision and accuracy, and their use in testing the performance of species richness estimators, with a literature review of estimator performance/Ecography 28: 815/829.
BRADLEY, R., and DRECHSLER, M., 2014. Types of Uncertainty.. Erkenn 79, 1225–1248.
CFR (Code of Federal Regulation-21 CFR) USA, 2021 Published by Office of the Federal Register National Archives Records Service, Animals.
CORRY, J.E.L. 1982. Quality assessment of culture media by the Miles and Misra method. In: Corry, J.E.L. (Ed.), Quality Assurance and Quality Control of Microbiological Culture Media. G.I.T. Verlag, Darmstadt, pp. 21–37.
DIMECH, W., FRANCIS, B., KOX, J., and ROBERTS, G., 2006. Calculating uncertainty of measurement for serology assays by use of precision and Bias. Clinical Chemistry, 52 (3): 526-529.
DYBKAER, R. 1995. Result, error and uncertainty. Scandinavian Journal of Clinical and Laboratory Investigation, 55: 97-118.
EUROCHEM GUIDE, 1998. A laboratory guide to method validation and related topics.
EXCENTRAL VERSION 2.1., 2008. Rules for out of control.
FEARN, T., and THOMPSON, M., 2001. A new test for sufficient homogeneity, Analyst, 126: 1414-1417.
GUIDANCE G104 (GUM), 1995. With minor corrections. 2014 American Association for Laboratories Accreditation. Guide for estimation of measurement uncertainty in testing.
GREINER, M., SOHR, D., and GOEBEL, P., 1995. A modified ROC analysis for the selection of cutoff values and the definition of intermediate results of serodiagnostic tests, Journal of immunological methods 185: 123–132.
ILAC-G8:09, 2019. Guidelines on Decision Rules and Statements of Conformity.
ISO 22117, 2010. International standard microbiology of food and animal feeding stuffs Specific requirements and guidance for proficiency testing by interlaboratory comparison.
ISO 8258, 2005. Establishes a guide to the use and understanding of the control chart approach to the methods for statistical control of a process.
ISO/FDIS 7218, 2007. General requirements and guidance for microbiological examinations. Update 2013.
ISO/IEC 17025, 2017. General requirements for the competence of testing and calibration laboratories.
ISO/CASCO. 2017 International Organization for Standardization. (General requirement for the competence of testing and calibration laboratories). Second Edition, ISO.CASCO Committee on conformity assessment.
ISO/IEC17043, 2010. 4.4.3Conformity Assessment-General requirements for proficiency testing.
ISO/TS 11133-1, 2014. General guideline on quality assurance for the preparation of culture media in the laboratory.
ISO/TS 11133-2, 2014. Preparation, Production, Storage and Performance testing of culture media.
ISO/TS34SC9W03/16140, 2017. Microbiology of the food chain-Method Validation-part3: protocol for the verification of reference and validated alternative methods implemented in a single laboratory.
ISO 3534-1, 2006. Statistics – Vocabulary and Symbols. International Standardisation Organisation, Geneva.
ISO/IEC GUIDE 99:2007 International vocabulary of metrology -- Basic and general concepts and associated terms (VIM)
JANET, E.L., CORRYA, BASIL JARVISB, SUE PASSMOREC, and ALAN HEDGESD, 2007. A critical review of measurement uncertainty in the enumeration of food micro-organisms. Food Microbiology 24 (2007) 230–253 DOI: 10.1016/j.fm.2006.05.003 · Source: PubMed
MANGHANI, K. 2011. Quality assurance: Importance of systems and standard operating procedures. Perspect Clin Res. 2011 Jan;2(1):34-7. doi: 10.4103/2229-3485.76288. PMID: 21584180; PMCID: PMC3088954.
NATA, 2009. Assessment of uncertainties of measurement for calibration and testing laboratories. Australia (Access 28 August 2009).
NORDTEST TR 537, 2004. Handbook for calculation of measurement uncertainty. Edition 2. Dr. Mikael Knysell, mik@qualab.se
NORDTEST TR 569, 2006. Internal Quality Control handbook for internal. www.Nordic innovation.net
NPAAG, 2009. Requirements for the estimation of measurement uncertainty. National Pathology Accreditation Advisory Group. Canberra (Access 28 August 2009).
OIE, 2016. Infectious disease. In: OIE quality standards and guidelines for veterinary laboratories, World Organization for Animal Health.
OIE, 2021. Infectious disease, In OIE quality standards and guidelines for veterinary laboratories, World Organization for Animal Health.
OIE, 2009. Manual of diagnostic tests and vaccines for terrestrial animals, Chapter 1.1.3. Quality management in veterinary testing laboratories, d) Uncertainty, pp. 27–33, World Organisation for Animal Health (accessed 28 August 2009).
PELZ F PETER ,MARCE.PFETSCH , SEBASTIAN KERSTING, MICHAEL KOHLER,ALEXANDER MATEI, TOBIAS MELZ, ROLAND PLATZ, MAXIMILIAN SCHAEFFNER, and STEFAN ULBRICH, 2021. In book: Mastering Uncertainty in Mechanical Engineering (pp.25-42) Chapter 2 Types of Uncertainty DOI:10.1007/978-3-030-78354-9_2
UNCERTAINTY ASSOCIATED WITH MICROBIO-LOGICAL ANALYSIS, 2006 Appendix J – STWG Part 3 – Uncertainty 7-8-06 Page 1 of 31 AOAC 9-30-05 Contract Deliverable for Contract 223-01-2464 Modification 12. The U.S. Food and Drug Administration Contract# 223-01-2464 Modification 12 Contract# 223-01-2464 Modification 12 August 10, 2006 August 10, 2006.
WHO, 2016. Manual For Organizing A National External Quality Assessment Programme For Health Laboratories And Other Testing Sites. ISBN 978 92 4 154967. © World Health Organization 2016. https://apps.who.int/iris/handle/10665/250117 | ||||
|
Statistics Article View: 308 PDF Download: 397 |
||||
