PROTOCOL FOR THE VALIDATION OF QUALITATIVE ALTERNATIVE METHODS OF MICROBIOLOGY

سال انتشار: 1397
نوع سند: مقاله کنفرانسی
زبان: انگلیسی
مشاهده: 337

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شناسه ملی سند علمی:

MEDISM19_459

تاریخ نمایه سازی: 13 مهر 1397

چکیده مقاله:

Background and Aim:Today, many alternative, mostly proprietary, methods exist that are used to assess the microbiological quality of raw materials and finished products and the microbiological status of manufacturing procedures. These methods are often faster and easier to perform than the corresponding standardized method.Methods:The method comparison study is the part of the validation process that is performed in the organizing laboratory. It consists of three parts namely the following: —comparative study of the results of the reference method to the results of the alternative methodin (naturally and/or artificially) contaminated samples (so-called sensitivity study); —comparative study to determine the relative level of detection (RLOD) in artificially contaminated samples (so-called RLOD study); —inclusivity/exclusivity study of the alternative method. The sensitivity study aims to determine the difference in sensitivity between the reference and the alternative method. A comparative study is conducted to evaluate the level of detection (LOD) of the alternative method against the reference method. The evaluation is based on the calculation of the relative level ofdetection (RLOD). In the study, replicates of artificially contaminated samples are used at three ormore levels of contamination. Preferably, the levels are known as it allows calculation of the LOD.Results:For inclusivity testing, at least 50 pure cultures of (target) microorganisms shall be tested and for exclusivity testing, at least 30 pure cultures of (non-target) microorganisms shall be tested.Conclusion:This article determines general principle and the technical protocol for the validation of qualitative alternative methods for microbiology in the food chain.

نویسندگان

Sareh Davarzani

Faculty of Food Industry and Agriculture, Department of Microbiology, Standard Research Institute (SRI), Karaj, Iran

Reza Soltani

Faculty of Food Industry and Agriculture, Department of Microbiology, Standard Research Institute (SRI), Karaj, Iran