Institute of Health Research, University of Exeter Medical School, Exeter EX2 4SG, UK
Institute of Health Research, University of Exeter Medical School, Exeter EX2 4SG, UK.
BMJ. 2015 Jan 20;350:h15. doi: 10.1136/bmj.h15.
To obtain summary estimates of the accuracy of a single baseline measurement of the Elecsys Troponin T high-sensitive assay (Roche Diagnostics) for the diagnosis of acute myocardial infarction in patients presenting to the emergency department.
Systematic review and meta-analysis of diagnostic test accuracy studies.
Medline, Embase, and other relevant electronic databases were searched for papers published between January 2006 and December 2013.
Studies were included if they evaluated the diagnostic accuracy of a single baseline measurement of Elecsys Troponin T high-sensitive assay for the diagnosis of acute myocardial infarction in patients presenting to the emergency department with suspected acute coronary syndrome.
The first author screened all titles and abstracts identified through the searches and selected all potentially relevant papers. The screening of the full texts, the data extraction, and the methodological quality assessment, using the adapted QUADAS-2 tool, were conducted independently by two reviewers with disagreements being resolved through discussion or arbitration. If appropriate, meta-analysis was conducted using the hierarchical bivariate model.
Twenty three studies reported the performance of the evaluated assay at presentation. The results for 14 ng/L and 3-5 ng/L cut-off values were pooled separately. At 14 ng/L (20 papers), the summary sensitivity was 89.5% (95% confidence interval 86.3% to 92.1%) and the summary specificity was 77.1% (68.7% to 83.7%). At 3-5 ng/L (six papers), the summary sensitivity was 97.4% (94.9% to 98.7%) and the summary specificity was 42.4% (31.2% to 54.5%). This means that if 21 of 100 consecutive patients have the target condition (21%, the median prevalence across the studies), 2 (95% confidence interval 2 to 3) of 21 patients with acute myocardial infarction will be missed (false negatives) if 14 ng/L is used as a cut-off value and 18 (13 to 25) of 79 patients without acute myocardial infarction will test positive (false positives). If the 3-5 ng/L cut-off value is used, <1 (0 to 1) patient with acute myocardial infarction will be missed and 46 (36 to 54) patients without acute myocardial infarction will test positive.
The results indicate that a single baseline measurement of the Elecsys Troponin T high-sensitive assay could be used to rule out acute myocardial infarction if lower cut-off values such as 3 ng/L or 5 ng/L are used. However, this method should be part of a comprehensive triage strategy and may not be appropriate for patients who present less than three hours after symptom onset. Care must also be exercised because of the higher imprecision of the evaluated assay and the greater effect of lot-to-lot reagent variation at low troponin concentrations.
PROSPERO registration number CRD42013003926.
总结 Elecsys Troponin T 高敏检测法（罗氏诊断）单次基线测量在急诊科就诊疑似急性冠脉综合征患者中诊断急性心肌梗死的准确性。
诊断性试验准确性系统评价和荟萃分析。
在 2006 年 1 月至 2013 年 12 月期间，检索了 Medline、Embase 和其他相关电子数据库中的文献。
如果研究评估了 Elecsys Troponin T 高敏检测法单次基线测量在急诊科就诊疑似急性冠脉综合征患者中诊断急性心肌梗死的准确性，则纳入研究。
第一作者筛选了所有检索到的标题和摘要，并选择了所有潜在相关的论文。两名评审员独立筛选全文、提取数据并使用适应性 QUADAS-2 工具进行方法学质量评估，如果存在分歧则通过讨论或仲裁解决。如果合适，使用分层双变量模型进行荟萃分析。
23 项研究报告了所评估检测法在就诊时的性能。分别汇总了 14ng/L 和 3-5ng/L 截断值的结果。在 14ng/L（20 项研究）时，汇总的敏感性为 89.5%（95%置信区间 86.3%至 92.1%），特异性为 77.1%（68.7%至 83.7%）。在 3-5ng/L（6 项研究）时，汇总的敏感性为 97.4%（94.9%至 98.7%），特异性为 42.4%（31.2%至 54.5%）。这意味着，如果连续 100 例患者中有 21 例（各研究的中位数患病率）存在目标疾病（21%），如果使用 14ng/L 作为截断值，则 21 例急性心肌梗死患者中将会有 2 例（95%置信区间 2 至 3）被漏诊（假阴性），而 79 例无急性心肌梗死患者中将会有 18 例（13 至 25）被误诊为阳性（假阳性）。如果使用 3-5ng/L 的截断值，将会有 <1（0 至 1）例急性心肌梗死患者被漏诊，而 79 例无急性心肌梗死患者中将会有 46 例（36 至 54）被误诊为阳性。
研究结果表明，如果使用较低的截断值（如 3ng/L 或 5ng/L），单次基线测量 Elecsys Troponin T 高敏检测法可用于排除急性心肌梗死。然而，该方法应作为综合分诊策略的一部分，并且可能不适用于症状发作后 3 小时内就诊的患者。由于评估检测法的不精确性更高以及在低肌钙蛋白浓度时试剂批间变化的影响更大，因此必须谨慎使用。
PROSPERO 注册号 CRD42013003926。
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