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EXPRESS: Repeat measurements on patient samples identifies unpredictable and poorly reproducible cardiac troponin results with a high-sensitivity cardiac troponin assay
Annals of Clinical Biochemistry: International Journal of Laboratory Medicine ( IF 2.2 ) Pub Date : 2021-07-16 , DOI: 10.1177/00045632211035804
Simone Drummond, Ching-Tong Mark, Nadia Caruso, Lorna Clark, Pete Kavsak

There is much current interest in the use of low-normal high-sensitivity cardiac troponin (hsTn) concentrations, with or without minimal change, to rule out myocardial infarction (MI). Clifford-Mobley’s observations demonstrate that this a challenge even for platforms measuring hsTnT.1 Analytical imprecision may also affect algorithms that use hsTn change alone to rule in MI. For example, the imprecision observed with the Ortho hsTnI assay (Ortho Clinical Diagnostics, New Jersey, United States), using quality control or patient pools, has been found to exceed the European Society of Cardiology 0/1h algorithm criterion.2 The Ortho hsTnI assay has also been shown to yield high and non-reproducible results (i.e., outliers), in addition to the problems with imprecision.3 Outliers are often identified by repeat centrifugation and repeat testing. However, Ortho hsTnI results above the 99th percentile cutoffs may be discordant with respect to other cardiac troponin assays and the clinical diagnosis, even when imprecision from duplicate analysis is acceptable.4 As part of a stability study assessing Ortho hsTnI concentrations in both EDTA plasma and lithium heparin plasma over 24h, we have observed that this interference is random and not related to time on cells.



中文翻译:

EXPRESS:使用高灵敏度心肌肌钙蛋白测定法对患者样本进行重复测量,确定不可预测且重现性差的心肌肌钙蛋白结果

目前人们对使用低正常高敏心肌肌钙蛋白 (hsTn) 浓度(无论是否有微小变化)来排除心肌梗塞 (MI) 非常感兴趣。Clifford-Mobleyâ????s 的观察表明,即使对于测量 hsTnT.1 的平台来说,这也是一个挑战。分析不精确也可能影响单独使用 hsTn 变化来统治 MI 的算法。例如,使用质量控制或患者库的 Ortho hsTnI 检测(Ortho Clinical Diagnostics,美国新泽西州)观察到的不精确性已超过欧洲心脏病学会 0/1h 算法标准。 2 Ortho hsTnI除了不精确的问题外,分析还被证明会产生高且不可重复的结果(即异常值)。3 异常值通常通过重复离心和重复测试来识别。

更新日期:2021-07-16
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