Jørgensen P J, Hørder M, Selmer J, Bøtker H E
Department of Clinical Chemistry, Odense University Hospital, Denmark.
Clin Chem. 1990 Aug;36(8 Pt 1):1502-5.
We have evaluated a new sensitive immunometric assay for the determination of creatine kinase (CK; EC 2.7.3.2) MB isoenzyme (NovoClone CK-MB), involving an enzyme label and two monoclonal antibodies directed against the B subunit and the M subunit, respectively. The anti-CK-B antibodies are bound to the solid phase. The assay was modified to be extremely sensitive and thus to measure the concentration range below and close to the cutoff value used for the diagnosis of myocardial infarction. A reference interval of 0-6 micrograms/L was found for 315 outpatients without myocardial diseases (132 men and 183 women); the overall median of the log-gaussian distribution was 1.91 micrograms/L (2.03 and 1.79 micrograms/L for men and women, respectively). Total and within-assay imprecision (CV) was less than 6% at the upper reference limit. The detection limit was 0.1 microgram/L. The assay provides a favorable signal-to-noise ratio: the calibrators 0.0, 2.0, and 30.0 micrograms/L give absorbances at 492 nm of 0.040, 0.140, and 1.600 A. respectively. We conclude that the assay provides biochemical identification of individuals with myocardial damage but without myocardial infarction.
我们评估了一种用于测定肌酸激酶（CK；EC 2.7.3.2）MB同工酶的新型灵敏免疫测定法（NovoClone CK-MB），该方法涉及酶标记以及分别针对B亚基和M亚基的两种单克隆抗体。抗CK-B抗体与固相结合。该测定法经过改进，变得极其灵敏，从而能够测量低于和接近用于诊断心肌梗死的临界值的浓度范围。在315名无心肌疾病的门诊患者（132名男性和183名女性）中发现参考区间为0 - 6微克/升；对数正态分布的总体中位数为1.91微克/升（男性和女性分别为2.03和1.79微克/升）。在参考上限处，总不精密度和批内不精密度（CV）均小于6%。检测限为0.1微克/升。该测定法具有良好的信噪比：校准品0.0、2.0和30.0微克/升在492纳米处的吸光度分别为0.040、0.140和1.600 A。我们得出结论，该测定法能够对有心肌损伤但无心肌梗死的个体进行生化鉴定。
