Christenson Robert H, Jacobs Ellis, Uettwiller-Geiger Denise, Estey Mathew P, Lewandrowski Kent, Koshy Thomas I, Kupfer Kenneth, Li Yin, Wesenberg James C
Department of Pathology, University of Maryland School of Medicine, Baltimore, MD.
Alere, Waltham, MA.
J Appl Lab Med. 2017 Mar 1;1(5):544-561. doi: 10.1373/jalm.2016.022640.
We examined the concordance of 13 commercial cardiac troponin (cTn) assays [point-of-care, high-sensitivity (hs), and conventional] using samples distributed across a continuum of results.
cTnI (11 assays) and cTnT (2 assays) were measured in 191 samples from 128 volunteers. cTn assays included Abbott (iSTAT, STAT, and hs), Alere (Cardio 3), Beckman (AccuTnI+3), Pathfast (cTnI-II), Ortho (Vitros), Siemens (LOCI, cTnI-Ultra, Xpand, Stratus CS), and Roche [4th Generation (Gen), hs]. Manufacturer-derived 99th percentile cutoffs were used to classify results as positive or negative. Alternative 99th percentile cutoffs were tested for some assays. Correlation was assessed using Passing-Bablok linear regression, bias was examined using Bland-Altman difference plots, and concordance/discordance of each method comparison was determined using the McNemar method.
Regression slopes ranged from 0.63 to 1.87, y-intercepts from 0.00 to 0.03 ng/mL, and r values from 0.93 to 0.99. The cTnT methods had a slope of 0.93, y-intercept of 0.02 ng/mL, and r value of 0.99. For the cTnI assays, positive, negative, and overall concordance was 76.2%-100%, 66.0%-100%, and 82.9%-98.4%, respectively. Overall concordance between the 4th Gen cTnT and hsTnT assays was 88.9%. A total of 30 of the 78 method comparisons showed significant differences in classification of samples (P <0.001); the iSTAT showed 10, hsTnT showed 9, AccuTnI+3 showed 5, Xpand showed 5, and Stratus CS showed 1. Using alternative 99th percentile cutoffs to those listed by manufacturers lowered the method discordance by 6-fold, from 30 to 5 (all involved iSTAT).
These data provide insight into characteristics of cTn methods and will assist the healthcare community in setting expectations for relationships among commercial cTn assays.
我们使用分布在连续结果范围内的样本，检验了13种商用心肌肌钙蛋白（cTn）检测方法（即时检测、高灵敏度（hs）和传统检测方法）之间的一致性。
对来自128名志愿者的191份样本进行了cTnI（11种检测方法）和cTnT（2种检测方法）检测。cTn检测方法包括雅培（iSTAT、STAT和hs）、雅培（Cardio 3）、贝克曼（AccuTnI+3）、Pathfast（cTnI-II）、奥瑟诊断（Vitros）、西门子（LOCI、cTnI-Ultra、Xpand、Stratus CS）和罗氏[第四代（Gen）、hs]。使用制造商提供的第99百分位数临界值将结果分类为阳性或阴性。对某些检测方法测试了替代的第99百分位数临界值。使用Passing-Bablok线性回归评估相关性，使用Bland-Altman差异图检查偏倚，并使用McNemar方法确定每种方法比较的一致性/不一致性。
回归斜率范围为0.63至1.87，y轴截距范围为0.00至0.03 ng/mL，r值范围为0.93至0.99。cTnT检测方法的斜率为0.93，y轴截距为0.02 ng/mL，r值为0.99。对于cTnI检测方法，阳性、阴性和总体一致性分别为76.2%-100%、66.0%-100%和82.9%-98.4%。第四代cTnT检测方法与hsTnT检测方法之间的总体一致性为88.9%。在78种方法比较中，共有30种在样本分类上存在显著差异（P<0.001）；iSTAT检测方法有10种，hsTnT检测方法有9种，AccuTnI+3检测方法有5种，Xpand检测方法有5种，Stratus CS检测方法有1种。使用替代制造商列出的第99百分位数临界值可将方法不一致性降低6倍，从30种降至5种（均涉及iSTAT）。
这些数据有助于了解cTn检测方法的特性，并将帮助医疗界对商用cTn检测方法之间的关系设定预期。
