Department of Laboratory Medicine and Pathology, Hennepin County Medical Center, and University of Minnesota, Minneapolis, MN;
Division of Cardiology, Department of Medicine, Hennepin County Medical Center and Minneapolis Heart Institute, Abbott-Northwestern Hospital, Minneapolis, MN;
Clin Chem. 2016 Aug;62(8):1115-9. doi: 10.1373/clinchem.2016.256305. Epub 2016 Jun 20.
We compared the incidence of undetectable [below the limit of detection (LoD)], measurable (LoD to 99th percentile), and increased cardiac troponin I (cTnI) concentrations above the 99th percentile between Abbott high-sensitivity cTnI (hs-cTnI) and contemporary cTnI assays in a US emergency department population.
Patients (n = 2100) presenting to the emergency department who had serial cTnI (0, 3, 6, 9 h) measurements ordered on clinical indication were enrolled. Contemporary cTnI [Abbott Architect used clinically; 99th percentile: 0.030 μg/L (30 ng/L)] and hs-cTnI [Abbott investigational; sex-specific 99th percentiles: female (F) 16 ng/L, male (M) 34 ng/L] assays simultaneously measured fresh EDTA plasma.
The hs-cTnI assay measured fewer undetectable cTnI concentrations compared to the contemporary cTnI assay across baseline (F: 31% vs 47%, M: 22% vs 40%) and serial (F: 21% vs 46%; M: 19% vs 54%) measurements. Conversely, the proportion of measurable cTnI concentrations was higher using hs-cTnI compared to contemporary cTnI assay across both baseline (F: 46% vs 31%; M: 60% vs 33%) and serial (F: 48% vs 28%; M: 83% vs 40%) measurements. The overall proportion of patients with increased cTnI concentrations above the 99th percentile was not significantly different between the contemporary (31%) and hs-cTnI (26%) assays (P = 0.09).
In patients presenting to the emergency department, the use of the Abbott hs-cTnI assay provides clinicians with more numeric cTnI concentrations. This occurs via a shift from results below the LoD to those between the LoD and the 99th percentile and does not increase in the number of cTnI concentrations above the 99th percentile.
我们比较了 Abbott 高敏肌钙蛋白 I（hs-cTnI）和当代肌钙蛋白 I 检测在检测限（LoD）以下、LoD 至 99 百分位之间和 99 百分位以上的不可检测（LoD 以下）、可检测（LoD 至 99 百分位）和升高的心脏肌钙蛋白 I（cTnI）浓度的发生率，这项研究在一个美国急诊人群中进行。
入组了因临床指征接受连续（0、3、6、9 h）cTnI 检测的 2100 名急诊科患者。同时检测了 Abbott 临床使用的当代 cTnI（Abbott Architect；99 百分位：0.030 μg/L（30 ng/L））和 hs-cTnI（Abbott 研究性检测；女性（F）99 百分位 16 ng/L，男性（M）99 百分位 34 ng/L）的新鲜 EDTA 血浆。
与当代 cTnI 检测相比，hs-cTnI 检测在基线（F：31% vs 47%，M：22% vs 40%）和连续测量时（F：21% vs 46%，M：19% vs 54%）测量到的不可检测 cTnI 浓度更少。相反，hs-cTnI 检测比当代 cTnI 检测在基线（F：46% vs 31%，M：60% vs 33%）和连续测量时（F：48% vs 28%，M：83% vs 40%）测量到的可检测 cTnI 浓度比例更高。当代 cTnI 检测（31%）和 hs-cTnI 检测（26%）的患者中，99 百分位以上 cTnI 浓度升高的患者比例无显著差异（P = 0.09）。
在急诊科就诊的患者中，Abbott hs-cTnI 检测为临床医生提供了更多的 cTnI 浓度数值。这是通过将结果从 LoD 以下转移到 LoD 与 99 百分位之间，而不是增加 99 百分位以上的 cTnI 浓度数量来实现的。
