OBJECTIVE To determine gender-specific reference limits of high-sensitivity (hs) cardiac troponins (cTn) and validity of hs assay designation for both genders. METHODS After screening with a questionnaire, 827 presumably healthy individuals were further selected based on clinical criteria (n = 740), clinical criteria plus cardiac imaging including stress magnetic resonance imaging or stress echocardiography (n = 726), and extended cardio-pulmonary parameters (n = 626). Blood samples were measured with hs-cTnT (Roche Diagnostics) on a cobas e602 analyzer as well as hs-cTnI (Abbott Diagnostics) on an ARCHITECTi2000SR. The impact of health definition, statistical methods, instrument selection and limit of detection (LoD) on overall and gender-specific 99th percentiles was assessed. RESULTS Median age was 56 years (50.9% female) for the total study cohort. 99th percentiles for females and males ranged between 13.1 and 13.3 ng/L and 16.8-19.9 ng/L for hs-cTnT as well as 10.3-12.5 ng/L and 27.4-29.7 ng/L for hs-cTnI depending on health definition. Utilization of stricter health definition criteria reduced the difference of the gender-specific 99th percentiles between males and females for hs-cTnT to 3.7 ng/L (males 16.8 ng/L, females 13.1 ng/L), whereas the difference rather increased for hs-cTnI to 19.4 ng/L (males 29.7 ng/L, females 10.3 ng/L). Values > LoD could be measured in the majority of males and females using hs-TnT (81.4-83.3% and 96.5-96.9%, respectively). In contrast, values > LoD could not be observed in the majority of females using hs-cTnI (38.4-41.1%). CONCLUSIONS In a well-phenotyped healthy cohort, reference values for hs-cTnT were slightly higher, whereas hs-cTnI cut-offs were considerably lower than previously observed. Gender differences were more pronounced in hs-cTnI than in hs-cTnT and were further reduced for hs-cTnT by application of stricter health definition criteria. Contrary to hs-cTnI, hs-cTnT fulfilled criteria for hs designation for both genders.

中文翻译：

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在表型良好的健康个体中高敏感性心脏肌钙蛋白T和I的性别特异性参考值和高敏感性测定名称的有效性。

目的确定高敏感性（hs）心肌肌钙蛋白（cTn）的性别特异性参考限和hs分析指定对两种性别的有效性。方法通过问卷调查后，根据临床标准（n = 740），临床标准加上心脏显像（包括应力磁共振成像或应力超声心动图（n = 726））和扩展的心肺参数（n = 726），进一步选择了827名可能健康的人。 n = 626）。血样在cobas e602分析仪上用hs-cTnT（罗氏诊断公司（Roche Diagnostics））测量，在ARCHITECTi2000SR上用hs-cTnI（Abbott Diagnostics）测量。评估了健康定义，统计方法，仪器选择和检出限（LoD）对总体和特定性别的第99个百分位数的影响。结果中位年龄为56岁（50。整个研究队列中女性为9％）。取决于健康定义，男女中第99个百分位点的hs-cTnT介于13.1和13.3 ng / L和16.8-19.9 ng / L之间，hs-cTnI介于10.3-12.5 ng / L和27.4-29.7 ng / L之间。通过采用更严格的健康定义标准，针对hs-cTnT的性别特定的第99个百分位数之间的差异降低至3.7 ng / L（男性为16.8 ng / L，女性为13.1 ng / L），而hs-cTnT的差异却有所增加-cTnI至19.4 ng / L（雄性29.7 ng / L，雌性10.3 ng / L）。可以使用hs-TnT在大多数男性和女性中测量值> LoD（分别为81.4-83.3％和96.5-96.9％）。相反，在大多数使用hs-cTnI的女性中，观察不到> LoD的值（38.4-41.1％）。结论在表型良好的健康人群中，hs-cTnT的参考值略高，而hs-cTnI的截止值则比以前观察到的要低得多。在hs-cTnI中，性别差异比在hs-cTnT中更为明显，并且通过应用更严格的健康定义标准，性别差异在hs-cTnT中进一步减小。与hs-cTnI相反，hs-cTnT符合两种性别的hs指定标准。