학술논문

Protocols of determining limits of detection am limits of quantitation for quantitative analytic methods / 定量分析法における検出限界および定量限界の評価法
Document Type
Journal Article
Source
臨床化学 / Japanese Journal of Clinical Chemistry. 2006, 35(3):280
Subject
blank
evaluation protocol
limit of blank
limit of detection
limit of quatitation
standardization
Language
Japanese
ISSN
0370-5633
2187-4077
Abstract
Practicality of the guideline “Protocols for determination of limiits of detection and limits of quantitation (EP17)” issued by NCCLS was evaluated both theoretically and experimentally by the JSCC Committee on Quality Management, In this report ISO 11843 document describing the concept of detection limits was reviewed and the NCCLS guideline was interpreted and summarized. The following two modifications were made to the guideline based on results of the evaluation: (1) methods for selection and preparation of blank specimens are presented and (2) use of so-called precision profile, which is constructed from replicate measurement of multiple clinical specimens, was proposed as a practical way of determining limits of quantitation.