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Preparation of highlypurifiedmonomeric human serum albumin as secondary reference material for standardization of urinary albumin immunoassays

https://asahikawa-med.repo.nii.ac.jp/records/4005
https://asahikawa-med.repo.nii.ac.jp/records/4005
82d9def8-7889-462c-92da-06909e49a4a5
名前 / ファイル ライセンス アクション
4464.pdf 4464.pdf (378.6 kB)
Item type 学術雑誌論文 / Journal Article_02(1)
公開日 2012-05-17
タイトル
タイトル Preparation of highlypurifiedmonomeric human serum albumin as secondary reference material for standardization of urinary albumin immunoassays
言語 en
言語
言語 eng
資源タイプ
資源タイプ journal article
著者 伊藤, 喜久

× 伊藤, 喜久

ja 伊藤, 喜久

ja-Kana イトウ, ヨシヒサ

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Ichihara, Kiyoshi

× Ichihara, Kiyoshi

en Ichihara, Kiyoshi

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Kish, Kouji

× Kish, Kouji

en Kish, Kouji

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Hosogaya, Shigem

× Hosogaya, Shigem

en Hosogaya, Shigem

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Yamada, Toshiyuki

× Yamada, Toshiyuki

en Yamada, Toshiyuki

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書誌情報 Clinica Chimica Act

巻 413, 号 1-2, p. 175-181, 発行日 2012-01-01
ISSN
収録物識別子タイプ PISSN
収録物識別子 0009-8981
DOI
識別子タイプ DOI
関連識別子 10.1016/j.cca.2011.09.016
リンクURL
内容記述タイプ Other
内容記述 【図表は本人の意向により載せません 】 | 【図表は本人の意向により載せません 】
抄録
内容記述タイプ Abstract
内容記述 Background : International external quality assessments have shown variation in results of urinary albumin among various immunoassays. A well-defined candidate reference material for urine albumin (cRM-UA) was prepared to improve standardization. Methods : cRM-UA was prepared from a commercially available preparation of human serum albumin by using gel-filtration HPLC. The value was assigned by transfer from ERM-DA470 using immunoassay systems qualified based on the linearity and variability observed in dilution tests of pooled urine and the calibrators. Effectiveness of recalibration using the cRM-UA was evaluated by measuring 129 urine specimens. Results : The cRM-UA had a monomeric albumin peak which accounted for 98.9% of the total area by gel filtration HPLC. The lyophilized preparation of the cRM-UA had suitable homogeneity, and short- and long-term stability. Nine of 14 immunoassays met the criteria were used for value assignment. The assigned concentration was 225.1 ± 9.11 mg/l [mean ± U: expanded uncertainty with k = 2] when reconstituted with 3.00 ml of purified water on weight basis. Recalibration of 7 qualified immunoassays using the cRM-UA resulted in between-method CV of 6.6%. Conclusions : The cRM-UA was successful in achieving standardization of urine albumin results among 7 immunoassays which possess performance attributes representing uniform reactivity to both cRM-UA and clinical urine samples.
言語 en
注記
内容記述タイプ Other
注記 http://dx.doi.org/10.1016/j.cca.2011.09.016
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内容記述タイプ Other
資源タイプ text
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内容記述タイプ Other
内容記述 application/pdf
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