著者

市原 清志 細萱 茂実 奥谷 竜太 吉本 茂 井藤 一久 亀子 光明 栢森 裕三 高木 康 中野 幸弘 芳賀 利一 本永 秀夫 中 甫

出版者

一般社団法人 日本臨床化学会

雑誌

臨床化学 (ISSN:03705633)

巻号頁・発行日

vol.35, no.3, pp.280-294, 2006-07-31 (Released:2012-11-27)

参考文献数

20

被引用文献数

4

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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.