The basic performance and clinical evaluation of creatinine kinase MB mass quantitation (L type Wako CK-MB mass)

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  • 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

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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.

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