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首页> 外文期刊>Translational research: the journal of laboratory and clinical medicine >The development and application of a high-sensitivity immunoassay for cardiac myosin-binding protein C
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The development and application of a high-sensitivity immunoassay for cardiac myosin-binding protein C

机译：心肌肌球蛋白结合蛋白C的高灵敏度免疫分析方法的开发与应用

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Cardiac troponins (cTns) are released and cleared slowly after myocardial injury. Cardiac myosin-binding protein C (cMyC) is a similar cardiac-restricted protein that has more rapid release and clearance kinetics. Direct comparisons are hampered by the lack of an assay for cMyC that matches the sensitivity of the contemporary assays for cTnI and cTnT. Using a novel pair of monoclonal antibodies, we generated a sensitive assay for MyC on the Erenna platform (Singulex) and compared serum concentrations with those of cTnI (Abbott) and cTnT (Roche) in stable ambulatory cardiac patients without evidence of acute cardiac injury or significant coronary artery stenoses. The assay for cMyC had a lower limit of detection of 0.4 ng/L, a lower limit of quantification (LLoQ) of 1.2 ng/L (LLoQ at 20% coefficient of variation (CV)) and reasonable recovery (107.1 +/- 3.7%; mean standard deviation), dilutional linearity (101.0 +/- 7.7%), and intraseries precision (CV, 11 +/- 3%) and interseries precision (CV, 13 +/- 3%). In 360 stable patients, cMyC was quantifiable in 359 patients and compared with cTnT and cTnI measured using contemporary high-sensitivity assays. cMyC concentration (median, 12.2 ng/L; interquartile range (IQR), 7.9-21.2 ng/L) was linearly correlated with those for cTnT (median, <3.0 ng/L; IQR, <3.0-4.9 ng/L; R = 0.56, P < 0.01) and cTnI (median, 2.10 ng/L; IQR, 1.3-4.2 ng/L; R = 0.77, P < 0.01) and showed similar dependencies on age, renal function, and left ventricular function. We have developed a high sensitivity assay for cMyC. Concentrations of cMyC in clinically stable patients are highly correlated with those of cTnT and cTnI. This high correlation may enable ratiometric comparisons between biomarkers to distinguish clinical instability.
机译：心肌肌钙蛋白（cTns）释放并在心肌损伤后缓慢清除。心脏肌球蛋白结合蛋白C（cMyC）是类似的心脏限制性蛋白，具有更快的释放和清除动力学。由于缺乏与现代cTnI和cTnT检测灵敏度相匹配的cMyC检测方法，因此无法进行直接比较。我们使用一对新颖的单克隆抗体，在Erenna平台（Singulex）上对MyC进行了灵敏测定，并将稳定的非卧床心脏病患者的血清浓度与cTnI（Abbott）和cTnT（Roche）的浓度进行了比较，而没有急性心脏损伤或明显的冠状动脉狭窄。 cMyC的检测下限为0.4 ng / L，定量下限（LLoQ）为1.2 ng / L（20％变异系数（CV）时的LLoQ），回收率合理（107.1 +/- 3.7） ％;平均标准偏差），稀释线性（101.0 +/- 7.7％），系列内精度（CV，11 +/- 3％）和系列间精度（CV，13 +/- 3％）。在360名稳定的患者中，cMyC在359名患者中可量化，并与使用当代高灵敏度测定法测量的cTnT和cTnI进行比较。 cMyC浓度（中位数12.2 ng / L;四分位间距（IQR）7.9-21.2 ng / L）与cTnT浓度线性相关（中位数<3.0 ng / L; IQR <3.0-4.9 ng / L; R = 0.56，P <0.01）和cTnI（中位数，2.10 ng / L; IQR，1.3-4.2 ng / L; R = 0.77，P <0.01），并显示出对年龄，肾功能和左心室功能的相似依赖性。我们已经开发了cMyC的高灵敏度检测方法。临床稳定患者中cMyC的浓度与cTnT和cTnI的浓度高度相关。这种高度相关性可以实现生物标记物之间的比率比较，以区分临床不稳定性。

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