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

Research output: Contribution to journalArticle

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

Fingerprint

Quality management
Limit of Detection
Guidelines

All Science Journal Classification (ASJC) codes

  • Clinical Biochemistry

Cite this

Ichihara, K., Hosogaya, S., Okutani, R., Yoshimoto, S., Itoh, K., Kameko, M., ... 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.

Protocols of determining limits of detection and limits of quantitation for quantitative analytical methods. / Ichihara, Kiyoshi; Hosogaya, Shigemi; Okutani, Ryuta; Yoshimoto, Shigeru; Itoh, Kazuhisa; Kameko, Mitsuaki; Kayamori, Yuzo; Takagi, Yasushi; Nakano, Yukihiro; Haga, Riichi; Motonaga, Hideo; Naka, Hajime.

In: Japanese Journal of Clinical Chemistry, Vol. 35, No. 3, 19.09.2006, p. 280-294.

Research output: Contribution to journalArticle

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, vol. 35, no. 3, pp. 280-294.
Ichihara K, Hosogaya S, Okutani R, Yoshimoto S, Itoh K, Kameko M et al. Protocols of determining limits of detection and limits of quantitation for quantitative analytical methods. Japanese Journal of Clinical Chemistry. 2006 Sep 19;35(3):280-294.
Ichihara, Kiyoshi ; Hosogaya, Shigemi ; Okutani, Ryuta ; Yoshimoto, Shigeru ; Itoh, Kazuhisa ; Kameko, Mitsuaki ; Kayamori, Yuzo ; Takagi, Yasushi ; Nakano, Yukihiro ; Haga, Riichi ; Motonaga, Hideo ; Naka, Hajime. / Protocols of determining limits of detection and limits of quantitation for quantitative analytical methods. In: Japanese Journal of Clinical Chemistry. 2006 ; Vol. 35, No. 3. pp. 280-294.
@article{2896257455ae424f9daad7877c18b2f5,
title = "Protocols of determining limits of detection and limits of quantitation for quantitative analytical methods",
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.",
author = "Kiyoshi Ichihara and Shigemi Hosogaya and Ryuta Okutani and Shigeru Yoshimoto and Kazuhisa Itoh and Mitsuaki Kameko and Yuzo Kayamori and Yasushi Takagi and Yukihiro Nakano and Riichi Haga and Hideo Motonaga and Hajime Naka",
year = "2006",
month = "9",
day = "19",
language = "English",
volume = "35",
pages = "280--294",
journal = "Japanese Journal of Clinical Chemistry",
issn = "0370-5633",
publisher = "Japan Society of Clinical Chemistry",
number = "3",

}

TY - JOUR

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 - 2006/9/19

Y1 - 2006/9/19

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.

UR - http://www.scopus.com/inward/record.url?scp=33748624898&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=33748624898&partnerID=8YFLogxK

M3 - Article

VL - 35

SP - 280

EP - 294

JO - Japanese Journal of Clinical Chemistry

JF - Japanese Journal of Clinical Chemistry

SN - 0370-5633

IS - 3

ER -