Protocols of determining limits of detection and limits of quantitation for quantitative analytical methods

Kiyoshi Ichihara, Shigemi Hosogaya, Ryuta Okutani, Shigeru Yoshimoto, Kazuhisa Itoh, Mitsuaki Kameko, Yuzo Kayamori, Yasushi Takagi, Yukihiro Nakano, Riichi Haga, Hideo Motonaga, Hajime Naka

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2 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)280-294
Number of pages15
JournalJapanese Journal of Clinical Chemistry
Volume35
Issue number3
Publication statusPublished - Sep 19 2006

All Science Journal Classification (ASJC) codes

  • Clinical Biochemistry

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    Ichihara, K., Hosogaya, S., Okutani, R., Yoshimoto, S., Itoh, K., Kameko, M., Kayamori, Y., Takagi, Y., Nakano, Y., Haga, R., Motonaga, H., & Naka, H. (2006). Protocols of determining limits of detection and limits of quantitation for quantitative analytical methods. Japanese Journal of Clinical Chemistry, 35(3), 280-294.