汎用自動分析機によるCK-MB蛋白量測定試薬「LタイプワコーCK-MB mass」の基礎的性能および臨床的妥当性の評価  [in Japanese] The basic performance and clinical evaluation of creatinine kinase MB mass quantitation (L type Wako CK-MB mass)  [in Japanese]

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Abstract

我々は,汎用自動分析装置で測定可能なラテックス比濁法を原理としたクレアチニンキナーゼMB分画(creatinine kinase MB)測定試薬「LタイプワコーCK-MB mass」(和光純薬株式会社)の基礎的性能,および臨床的妥当性評価を行った.測定の同時再現性および日差再現性は,変動係数coefficient of variation(C.V.)は5%以下と良好であった.測定の安定性は15日間まで良好であった.測定の直線性は,範囲1.2~200.0 ng/mLまで良好であり,プロゾーン現象は認めなかった.免疫阻害活性法を原理とした対照試薬との相関性はy = 0.97x – 8.6,相関係数r = 0.986と良好であった.共存物質による影響は全ての物質で認められなかった.心筋梗塞患者と非心筋梗塞患者の診断一致率はトロポニンI測定>CK-MB蛋白量測定>CK-MB活性測定の順に高く,CK-MB活性測定よりも蛋白量測定の有用性が確認できた.本試薬の基本的性能評価および臨床的妥当性評価の結果は良好であり,日常検査に適している.

We performed the basic and clinical evaluation of creatinine kinase MB (CK-MB) by isozyme mass quantitation using latex turbidimetry (L-type Wako CK-MB mass, Wako Pure Chemical Industries, Ltd.). The within-run and between-run repeatabilities of the assay were satisfactory, with a coefficient of variation (CV) below 5%. The assay reagent was confirmed to be stable for 15 days. The assay linearity was observed in the range of 1.2–200.0 ng/mL, without apparent prozone phenomenon. The comparison of this assay with a method based on enzyme inhibition immunoassay yielded the linear regression equation: y = 0.97x − 8.6, with a correlation coefficient of 0.986. There was no interference by co-existing substances. The concordance rates for diagnosis of myocardial infarction and nonmyocardial infarction were high in the order of troponin I > CK-MB mass > CK-MB activity, revealing the usefulness of CK-MB mass measurement. The basic performance and clinical validity of CK-MB assay based on this reagent were shown to be satisfactory for routine use in the laboratory.

Journal

  • Japanese Journal of Medical Technology

    Japanese Journal of Medical Technology 63(5), 590-595, 2014

    Japanese Association of Medical Technologists

Codes

  • NII Article ID (NAID)
    130004709173
  • Text Lang
    JPN
  • ISSN
    0915-8669
  • Data Source
    J-STAGE 
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