Determination of 19 Cardiac Troponin I and T Assay 99th Percentile Values from a Common Presumably Healthy Population
Determination of 19 Cardiac Troponin I and T Assay 99th Percentile Values from a Common Presumably Healthy Population
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DOI：
10.1373/clinchem.2012.192716
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发表时间：
2012-11-01
影响因子：
9.3
通讯作者：
Murakami, MaryAnn M.
中科院分区：
文献类型：
--
作者：
Apple, Fred S.;Ler, Ranka;Murakami, MaryAnn M.
背景技术背景：在一个单一的人口之间的测定可比性的99第99次肌钙蛋白浓度尚未进行系统的评估大量的assessment.METHODS：我们确定了99第99次肌钙蛋白测定肝素血浆样本从人口272和252大概健康的男性和女性，分别为19个心肌肌钙蛋白。评估的检测试剂盒包括来自罗氏的1种心肌肌钙蛋白T（cTnT）检测试剂盒和来自雅培、Mere、贝克曼、bioMerieux、仪器实验室、Ortho-Clinical Diagnostics、Singulex、西门子和罗氏的18种cTnI检测试剂盒。结果：高灵敏度cTnI（hs-cTnI）检测的第99次重复数为23 ~ 58 ng/L，第99次重复数为23 ~ 58 ng/L。至少80%的人有可测量的hs-cTnI，而只有25%的人有可测量的高灵敏度cTnT。所有高灵敏度心肌肌钙蛋白测定的第99次重复性均为男性的1.2-2.4倍。对于9种敏感的当代cTnI检测，第99次重复检测的范围为12 - 392 ng/L，只有Beckman检测在相当一部分人群中给出了可测量的浓度（35% vs.
BACKGROUND: Between-assay comparability of 99th percentiles for cardiac troponin concentrations has not been assessed systematically in a single population for a large number of assays.METHODS: We determined 99th percentiles for 19 cardiac troponin assays in heparin plasma samples from a population of 272 and 252 presumably healthy males and females, respectively. The assays evaluated included 1 cardiac troponin T (cTnT) assay from Roche and 18 cTnI assays from Abbott, Mere, Beckman, bioMerieux, Instrumentation Laboratory, Ortho-Clinical Diagnostics, Singulex, Siemens, and Roche. Five of these assays were categorized as high-sensitivity, 9 as sensitive-contemporary, and 5 as point-of-care (POC) assays.RESULTS: For high-sensitivity cTnI (hs-cTnI) assays 99th percentiles varied from 23 to 58 ng/L. At least 80% of individuals had measurable hs-cTnI, whereas only 25% had measurable high-sensitivity cTnT. All high-sensitivity cardic troponin assays had 99th percentiles that were 1.2-2.4-fold higher in males than females. For the 9 sensitive-contemporary cTnI assays, 99th percentiles varied from 12 to 392 ng/L, and only the Beckman assay gave measurable concentrations in a substantial portion of the population (35% vs