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Evaluation of a novel serum IgG4 assay and determination of reference interval for the Japanese population
http://hdl.handle.net/2241/00160181
http://hdl.handle.net/2241/001601812ffb27dd-c31e-4a66-8b1b-cfe3020c0490
名前 / ファイル | ライセンス | アクション |
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CCA_501-136 (623.5 kB)
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Item type | Journal Article(1) | |||||||||||
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公開日 | 2020-06-23 | |||||||||||
タイトル | ||||||||||||
言語 | en | |||||||||||
タイトル | Evaluation of a novel serum IgG4 assay and determination of reference interval for the Japanese population | |||||||||||
言語 | ||||||||||||
言語 | eng | |||||||||||
資源タイプ | ||||||||||||
資源 | http://purl.org/coar/resource_type/c_6501 | |||||||||||
タイプ | journal article | |||||||||||
著者 |
山内, 一由
× 山内, 一由
WEKO
465
× Usami, Yoko× Ichihara, Kiyoshi× Uehara, Takeshi× Sugano, Mitsutoshi× Ishimine, Nau× Kawasaki, Kenji× Hamano, Hideaki× Honda, Takayuki |
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抄録 | ||||||||||||
内容記述タイプ | Abstract | |||||||||||
内容記述 | Background IgG4-related disease (IgG4-RD) is a new syndrome characterized by elevated serum IgG4 concentration and tissue infiltration of IgG4-positive plasma cells. Here, we evaluated the analytical performance of a new IgG4 assay reagent featuring a wide dynamic range, highly specific monoclonal antibody, and the reversed passive latex agglutination assay and determined the IgG4 reference interval (RI) for the Japanese population. Methods Performance evaluations were conducted on precision, linearity, sensitivity, interference, and method comparison with The Binding Site (TBS) and Siemens reagents. The RI was derived by the parametric method from 619 apparently healthy Japanese 18 to 65 years of age. Results Between-day precisions ranged from 1.99 to 5.52 CV%. Linearity was confirmed up to 5.0 g/l. The limit of quantitation was 0.085 g/l. Interfering substances did not significantly influence values. Method comparison among the 3 reagents yielded correlation coefficients between 0.973 and 0.988. Values for the new reagent matched those of TBS reagent except at a higher concentration range, where reactivity dissociated. The RI was 0.11–1.21 g/l without distinction by sex and age. Conclusion The novel IgG4 assay reagent demonstrated satisfactory analytical performance for clinical use. Because of matched value with TBS reagent at low concentrations, it is possible to use the IgG4-RD cut-off value determined by TBS reagent. |
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書誌情報 |
en : Clinica Chimica Acta 巻 501, p. 136-141, 発行日 2020-02 |
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ISSN | ||||||||||||
収録物識別子タイプ | ISSN | |||||||||||
収録物識別子 | 0009-8981 | |||||||||||
書誌レコードID | ||||||||||||
収録物識別子タイプ | NCID | |||||||||||
収録物識別子 | AA00607421 | |||||||||||
PubMed番号 | ||||||||||||
識別子タイプ | PMID | |||||||||||
関連識別子 | 31730813 | |||||||||||
DOI | ||||||||||||
識別子タイプ | DOI | |||||||||||
関連識別子 | 10.1016/j.cca.2019.10.032 | |||||||||||
権利 | ||||||||||||
権利情報 | © 2019 The Authors. | |||||||||||
権利 | ||||||||||||
権利情報 | This is an open access article under the CC BY license (http://creativecommons.org/licenses/BY/4.0/). | |||||||||||
著者版フラグ | ||||||||||||
値 | publisher | |||||||||||
出版者 | ||||||||||||
出版者 | Elsevier B.V. |