Abstract：
BACKGROUND: The European Society of Cardiology (ESC) guidelines recommend a dynamic (0-1h) cardiac troponin (cTn) determination for non-ST elevation myocardial infarction diagnosis. For patients with low cTn levels, a discharge from emergency can be considered. Nevertheless, cTn cutoffs for discharge are lower than the limits of quantification proposed by laboratory reagent suppliers.
OBJECTIVE: Validate cTn assay on the Elecsys STAT kit.
METHODS: Precision, trueness, repeatability and within-laboratory variability were calculated from internal quality control and plasma pooled at 5.78 and 10.73 ng/L. Accuracy was calculated from external quality control. Uncertainty of measurement was calculated from (i) the uncertainty of the standard and control values and (ii) by precision from pooled plasma. Distribution of precision results from pooled plasma has been evaluated by bootstrap simulations. Dilution linearity tests with patient plasma were performed to evaluate the method for values near 5 ng/L.
RESULTS: Precision and trueness ranged from 1.35 to 4.45% and from 0.14 to -3.74%, respectively. Accuracy results ranged from 101.40 to 104.90%. Within laboratory variability was 2.91%. Uncertainty ranged from 3.66% to 19.90% for higher (2188) to lower values (5.78 ng/L). Bootstrap simulations allowed utilization of precision data from pooled plasma to evaluate cTn assay. The method was linear from 4.48 to 39.80 ng/L. A linear regression model best described the data.
CONCLUSIONS: Elecsys STAT method provides accurate cTn results, including patients with cTn results categorizing them as \'rule-out\' in the ESC guidelines.
OBJECTIVE: Validate cTn assay on the Elecsys STAT kit.
METHODS: Precision, trueness, repeatability and within-laboratory variability were calculated from internal quality control and plasma pooled at 5.78 and 10.73 ng/L. Accuracy was calculated from external quality control. Uncertainty of measurement was calculated from (i) the uncertainty of the standard and control values and (ii) by precision from pooled plasma. Distribution of precision results from pooled plasma has been evaluated by bootstrap simulations. Dilution linearity tests with patient plasma were performed to evaluate the method for values near 5 ng/L.
RESULTS: Precision and trueness ranged from 1.35 to 4.45% and from 0.14 to -3.74%, respectively. Accuracy results ranged from 101.40 to 104.90%. Within laboratory variability was 2.91%. Uncertainty ranged from 3.66% to 19.90% for higher (2188) to lower values (5.78 ng/L). Bootstrap simulations allowed utilization of precision data from pooled plasma to evaluate cTn assay. The method was linear from 4.48 to 39.80 ng/L. A linear regression model best described the data.
CONCLUSIONS: Elecsys STAT method provides accurate cTn results, including patients with cTn results categorizing them as \'rule-out\' in the ESC guidelines.
摘要：
背景：欧洲心脏病学会（ESC）指南推荐动态（0-1h）测定心肌肌钙蛋白（cTn）用于非ST段抬高型心肌梗死的诊断。对于低cTn水平的患者，可以考虑紧急出院。然而，排放的cTn截止值低于实验室试剂供应商提出的定量限值。
目的：在ElecsysSTAT试剂盒上验证cTn测定。
方法：精度，真实,重复性和实验室内的变异性是根据内部质量控制和5.78和10.73ng/L的血浆进行计算的。从外部质量控制计算准确性。测量的不确定度是根据（i）标准和对照值的不确定度和（ii）通过汇集的血浆的精密度来计算的。已通过自举模拟评估了来自汇集的等离子体的精度结果的分布。使用患者血浆进行稀释线性测试，以评估接近5ng/L的值的方法。
结果：精度和正确度范围为1.35％至4.45％和0.14％至-3.74％，分别。准确率为101.40～104.90%。实验室内变异性为2.91%。对于较高的值（2188）到较低的值（5.78ng/L），不确定性范围从3.66％到19.90％。Bootstrap模拟允许利用来自汇集血浆的精确度数据来评估cTn测定。该方法在4.48至39.80ng/L范围内呈线性关系。线性回归模型最好地描述了数据。
结论：ElecsysSTAT方法提供了准确的cTn结果，包括cTn结果在ESC指南中将其分类为“排除”的患者。
目的：在ElecsysSTAT试剂盒上验证cTn测定。
方法：精度，真实,重复性和实验室内的变异性是根据内部质量控制和5.78和10.73ng/L的血浆进行计算的。从外部质量控制计算准确性。测量的不确定度是根据（i）标准和对照值的不确定度和（ii）通过汇集的血浆的精密度来计算的。已通过自举模拟评估了来自汇集的等离子体的精度结果的分布。使用患者血浆进行稀释线性测试，以评估接近5ng/L的值的方法。
结果：精度和正确度范围为1.35％至4.45％和0.14％至-3.74％，分别。准确率为101.40～104.90%。实验室内变异性为2.91%。对于较高的值（2188）到较低的值（5.78ng/L），不确定性范围从3.66％到19.90％。Bootstrap模拟允许利用来自汇集血浆的精确度数据来评估cTn测定。该方法在4.48至39.80ng/L范围内呈线性关系。线性回归模型最好地描述了数据。
结论：ElecsysSTAT方法提供了准确的cTn结果，包括cTn结果在ESC指南中将其分类为“排除”的患者。
