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[State of the art and method validations: application to fidelity performance]
F Scherrer1, R C Boisson, J C Eynard
1LABM Buatois et Chamard, 71, Avenue Gabriel Péri (RN7), Roussillon. fscherrer@labobuatoischamard.fr
Annales De Biologie Clinique
|December 19, 2008
Summary
Clinical laboratories in France are improving quality management through accreditation. This study analyzed method validation, specifically fidelity (repeatability and reproducibility) for quantitative methods, to define acceptable performance limits.
Area of Science:
- Clinical laboratory science
- Quality management systems
- Analytical chemistry
Background:
- Quality management is crucial for clinical laboratories in France.
- Accreditation signifies laboratory competence for specific tasks.
- Method validation, including fidelity, is essential for accreditation.
Purpose of the Study:
- To report on fidelity performances of quantitative methods in clinical laboratories.
- To evaluate performance data from internal quality controls (ProBioQual).
- To discuss approaches for defining acceptability limits for method fidelity.
Main Methods:
- Analysis of fidelity (repeatability and reproducibility) data from ProBioQual participants in 2000 and 2006.
- Comparison of obtained performances against predefined targets (biological variation, state of the art).
- Discussion of various strategies for setting performance acceptability limits.
Main Results:
- Fidelity performances were assessed under routine laboratory conditions.
- Data from 2000 and 2006 provided insights into method performance trends.
- The study highlights the importance of internal quality controls in performance evaluation.
Conclusions:
- Method fidelity is a critical parameter for laboratory accreditation.
- Internal quality controls like ProBioQual are valuable for assessing routine performance.
- Defining appropriate acceptability limits for method validation requires careful consideration of performance data.
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