Department of Pathology and Molecular Medicine, McMaster University, Hamilton, ON, Canada; Hamilton Health Sciences, Hamilton, ON, Canada.
Division of Emergency Medicine, McMaster University, Hamilton, ON, Canada.
Clin Chim Acta. 2018 Dec;487:216-221. doi: 10.1016/j.cca.2018.10.012. Epub 2018 Oct 6.
International recommendations on high-sensitivity cardiac troponin (hs-cTn) testing recommend that laboratories select only one sample type for testing. We evaluated the Siemens ADVIA Centaur hs-cTnI assay in serum and thereby provide information on imprecision, long-term storage stability, freeze-thaw stability, method comparison to other hs-cTnI assays, and clinical performance.
Patients with chest pain onset <6 h who already had Roche hs-cTnT, Beckman hs-cTnI and Abbott hs-cTnI results recorded and had non-thawed and frozen serum aliquots formed the study population (n = 134 patients with 305 serum aliquots obtained at either 0, 3 or 6 h stored below -70 °C since 2003) for measurement with the Siemens hs-cTnI assay in 2018. Receiver-operating characteristic curve analyses for myocardial infarction (MI) using the highest obtained hs-cTn concentration was performed. Additional comparison testing on serum samples stored frozen (at -70 °C for <1 month in 2018) for the Siemens and Abbott hs-cTnI assays were performed, as well as precision testing in serum pools and freeze-thaw stability testing.
The Siemens hs-cTnI assay had an area under the curve (AUC) of 0.978 (95%CI: 0.937-0.996) for MI in the study cohort (Roche hs-cTnT AUC = 0.965 and Abbott AUC = 0.973). The Siemens hs-cTnI assay yielded higher cTnI concentrations than the other hs-cTn assays, with the same proportional bias (slope = 1.4) between the Siemens and Abbott hs-cTnI assays obtained from serum samples collected in 2003 and 2018. Over 3 months, a low serum pool of 3.5 ng/l achieved a CV of 20% (SD = 0.7, n = 42) and a high serum pool of 820 ng/l achieved a CV of 2.3% (SD = 20, n = 42). Three different serum pools recovered within 10% from baseline concentration after 5 freeze-thaw cycles for the Siemens hs-cTnI assay.
In serum, the Siemens ADVIA Centaur hs-cTnI assay had excellent clinical performance for MI in an early chest pain onset population, acceptable precision at normal and highly elevated cTnI concentrations, long-term storage stability (15 y storage below -70 °C) and acceptable freeze-thaw stability, all of which supports serum as an acceptable sample type to use in clinical studies and in clinical practice.
国际高敏心肌肌钙蛋白（hs-cTn）检测建议指出，实验室应仅选择一种样本类型进行检测。我们评估了西门子 ADVIA Centaur hs-cTnI 检测在血清中的应用，并提供了关于不精密度、长期储存稳定性、冻融稳定性、与其他 hs-cTnI 检测方法的比较以及临床性能的信息。
胸痛发作<6 h 的患者，已经记录了罗氏 hs-cTnT、贝克曼 hs-cTnI 和雅培 hs-cTnI 的结果，且已采集非冻存和冻存血清等分试样（2003 年以来，305 份血清等分试样在< -70°C 下储存，分别在 0、3 或 6 h 获得），以便在 2018 年使用西门子 hs-cTnI 检测进行检测。使用最高获得的 hs-cTn 浓度进行心肌梗死（MI）的受试者工作特征曲线分析。对西门子和雅培 hs-cTnI 检测的血清样本进行了冷冻储存（2018 年<1 个月内于-70°C 储存）的附加比较测试，以及血清池的精密度测试和冻融稳定性测试。
在研究队列中，西门子 hs-cTnI 检测的 MI 曲线下面积（AUC）为 0.978（95%CI：0.937-0.996）（罗氏 hs-cTnT AUC=0.965，雅培 AUC=0.973）。与其他 hs-cTn 检测相比，西门子 hs-cTnI 检测的 cTnI 浓度更高，在 2003 年和 2018 年采集的血清样本中，西门子和雅培 hs-cTnI 检测之间的比例偏差（斜率=1.4）相同。在 3 个月的时间里，低浓度的 3.5ng/l 血清池达到了 20%的 CV（SD=0.7，n=42），高浓度的 820ng/l 血清池达到了 2.3%的 CV（SD=20，n=42）。西门子 hs-cTnI 检测的 3 种不同血清池在 5 次冻融循环后，从基线浓度恢复到 10%以内。
在血清中，西门子 ADVIA Centaur hs-cTnI 检测在胸痛发作早期人群中具有出色的 MI 临床性能，在正常和高浓度 cTnI 时具有可接受的精密度、长期储存稳定性（-70°C 下储存 15 年）和可接受的冻融稳定性，这些均支持血清作为临床研究和临床实践中可接受的样本类型。
