Browsing tag: parametry metody

Walidacja i weryfikacja metod i testów diagnostycznych w laboratorium mikrobiologicznym

Validation and verification methods and diagnostic tests in the microbiology laboratory
E. Stefaniuk, K. Bosacka, W. Hryniewicz

1. Wprowadzenie. 2. Walidacja i weryfikacja metod i testów diagnostycznych w laboratorium mikrobiologicznym. 2.1. Weryfikacja i walidacja metody. 2.2. Weryfikacja i walidacja testów. 2.2. Walidacja metod biologicznych. 3. Procedura walidacyjna – zasady. 3.1. Plan walidacji. 3.2. Protokół walidacji. 4. Rewalidacja. 5. Procedura weryfikacji metody komercyjnej – przykład. 5.1. Cel badania. 5.2. Plan badania. 5.2.1. Zasada wykonania oznaczeń. 5.2.2. Parametry i kryteria akceptacji. Dokładność. Precyzja. 5.3. Wyniki i obliczenia. 5.3.1. Dokładność. 5.3.2. Precyzja w warunkach powtarzalności. 5.3.3. Precyzja w warunkach odtwarzalności. 5.3.4. Przedstawienie precyzji w formie graficznej. 5.4. Wyniki a kryteria akceptacji. 5.5. Stwierdzenie walidacyjne. 6. Podsumowanie

Abstract: There are a number of measurable factors evidence of the “quality” of laboratory tests. They allow to evaluate the laboratory proficiency, staff competency and applied technologies. There is a duty of each laboratory to prove that the method meets the quality requirements and is suitable for a particular purpose and result is credible. There are many acts that require verification and validation procedures in a laboratory. The aim of this article is to present a concept of validation and verification in microbiology and give an explanation of the difference between these processes. In this study a validation and verification parameters for the methods (e.g. accuracy, precision, repeatability, reproducibility, ruggedness, LOD, LOQ, linearity) were also described and they were divided into quantitative and qualitative methods. Parameters for tests validation and verification included sensitivity, specificity PPV, NPV. In the second part of the study an example of verification process of commercial methods is presented. A various the steps of the verification tests, the rules for calculation parameters and conclusions are also shown.

1. Introduction. 2. Validation and verification methods and diagnostic tests in the laboratory. 2.1. Verification and validation of the methods. 2.2. Verification and validation of the tests. 2.2. Validation of the biological methods. 3. Validation procedure – rules. 3.1. Validation scheme. 3.2. Validation protocol. 4. Revalidation. 5. Verification procedure of the commercial method – an example. 5.1. Aim of the study. 5.2. The study plan. 5.2.1. The principle study. 5.2.2. The parameters and acceptance criteria. Accuracy. Precision. 5.3. Results and calculations. 5.3.1. Accuracy. 5.3.2. Precision under repeatability conditions. 5.3.3. Precision under reproducibility conditions. 5.3.4. Presentation of precision in graphical form. 5.4. Results and the acceptance criteria. 5.5. The statement validation. 6. Summary