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

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

Division of Medical Technology

Research output: Contribution to journal › Article › peer-review

6 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 language	English
Pages (from-to)	280-294
Number of pages	15
Journal	Japanese Journal of Clinical Chemistry
Volume	35
Issue number	3
Publication status	Published - 2006

All Science Journal Classification (ASJC) codes

Clinical Biochemistry

Cite this

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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.",

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T1 - Protocols of determining limits of detection and limits of quantitation for quantitative analytical methods

AU - Ichihara, Kiyoshi

AU - Hosogaya, Shigemi

AU - Okutani, Ryuta

AU - Yoshimoto, Shigeru

AU - Itoh, Kazuhisa

AU - Kameko, Mitsuaki

AU - Kayamori, Yuzo

AU - Takagi, Yasushi

AU - Nakano, Yukihiro

AU - Haga, Riichi

AU - Motonaga, Hideo

AU - Naka, Hajime

PY - 2006

Y1 - 2006

N2 - 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.

AB - 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.

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

Abstract

All Science Journal Classification (ASJC) codes

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