仅用肌钙蛋白的曼彻斯特急性冠状动脉综合征（T-MACS）决策辅助工具与即时检测心肌肌钙蛋白检测的诊断准确性。
Diagnostic accuracy of the Troponin-only Manchester Acute Coronary Syndromes (T-MACS) decision aid with a point-of-care cardiac troponin assay.
机构信息
Division of Cardiovascular Sciences, The University of Manchester, Manchester, UK
College of Applied Medical Sciences, King Saud bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia.
出版信息
Emerg Med J. 2020 Apr;37(4):223-228. doi: 10.1136/emermed-2019-208882. Epub 2020 Feb 11.
OBJECTIVE
Point-of-care (POC) cardiac troponin (cTn) assays have a rapid turnaround time but are generally less sensitive than laboratory-based assays. Previous research found that the Abbott i-Stat cardiac troponin I (cTnI) assay has good diagnostic accuracy when used with the Troponin-only Manchester Acute Coronary Syndromes (T-MACS) decision aid and serial sampling over 3 hours. Accuracy of other assays may differ. We therefore evaluated the diagnostic accuracy of a different POC cTnI assay with serial sampling over 3 hours, both with T-MACS and when used alone.
METHODS
In a prospective diagnostic accuracy study at eight EDs in England (July 2015-October 2017), we collected clinical data from consenting adults with suspected ACS at the time of assessment in the ED. Blood samples were drawn on arrival and 3 hours later for POC cTnI (Cardio 3 Triage, Alere). The target condition was an adjudicated diagnosis of acute myocardial infarction (AMI), based on reference standard serial laboratory-based cTn testing. We calculated test characteristics for POC cTnI using the limit of detection (LoD, 0.01 µg/L) and the T-MACS decision aid.
RESULTS
Of 347 participants, 59 (14.9%) had AMI. With serial POC cTnI testing over 3 hours, POC cTnI at the LoD cut-off ruled out AMI in 193 (55.6%) patients with 98.1% sensitivity (95% CI 89.9% to 100.0%) and 99.5% negative predictive value (NPV, 95% CI 96.5% to 99.9%). T-MACS ruled out AMI in 117 (33.7%) patients with 98.1% sensitivity (95% CI 89.9% to 100%) and 99.2% NPV (95% CI 94.3% to 99.9%). T-MACS ruled in AMI with 97.9% specificity (95% CI 95.8% to 99.5%) and 83.7% positive predictive value (95% CI 70.6% to 91.7%).
CONCLUSIONS
With serial sampling over 3 hours, the Alere Cardio 3 Triage cTnI assay has relatively high NPV for AMI using either the LoD cut-off alone or the T-MACS decision aid. However, wide CIs around the measures of diagnostic accuracy mean that further prospective testing of this strategy is required before clinical implementation.
TRIAL REGISTRATION NUMBER
UKCRN 18000.
目的
即时检测（POC）心肌肌钙蛋白（cTn）检测具有快速周转时间，但通常比基于实验室的检测方法灵敏度低。先前的研究发现，当与 Troponin-only Manchester Acute Coronary Syndromes（T-MACS）决策辅助工具和 3 小时以上的连续采样一起使用时，Abbott i-Stat 心肌肌钙蛋白 I（cTnI）检测具有良好的诊断准确性。其他检测方法的准确性可能不同。因此，我们评估了另一种不同的 POC cTnI 检测方法在 3 小时以上连续采样时的诊断准确性，包括 T-MACS 和单独使用时的诊断准确性。
方法
在英格兰 8 家急诊室进行的一项前瞻性诊断准确性研究中（2015 年 7 月至 2017 年 10 月），我们在 ED 评估时从疑似 ACS 的成年患者处收集临床数据。在到达时和 3 小时后采集血液样本进行即时检测（Cardio 3 Triage，Alere）。目标条件是根据参考标准连续实验室检测 cTn 确定急性心肌梗死（AMI）的明确诊断。我们使用检测限（LoD，0.01μg/L）和 T-MACS 决策辅助工具计算 POC cTnI 的检测特性。
结果
在 347 名参与者中，59 名（14.9%）患有 AMI。使用 3 小时以上的连续 POC cTnI 检测，在 LoD 截止值时，POC cTnI 排除了 193 名（55.6%）患者的 AMI，具有 98.1%的敏感性（95%CI 89.9%至 100.0%）和 99.5%的阴性预测值（NPV，95%CI 96.5%至 99.9%）。T-MACS 排除了 117 名（33.7%）患者的 AMI，具有 98.1%的敏感性（95%CI 89.9%至 100%）和 99.2%的 NPV（95%CI 94.3%至 99.9%）。T-MACS 特异性排除 AMI 的准确率为 97.9%（95%CI 95.8%至 99.5%），阳性预测值为 83.7%（95%CI 70.6%至 91.7%）。
结论
使用 3 小时以上的连续采样，Alere Cardio 3 Triage cTnI 检测在单独使用 LoD 截止值或 T-MACS 决策辅助工具时，对 AMI 具有相对较高的 NPV。然而，诊断准确性衡量标准的宽置信区间意味着在临床实施之前，需要进一步对该策略进行前瞻性测试。
试验注册编号
UKCRN 18000。
Zotero 插件