Acad Emerg Med. 1997 Nov;4(11):1018-24.
To evaluate the performance of a new bedside whole-blood rapid assay for cardiac troponin T (cTnT) in patients presenting to the ED with symptoms consistent with acute coronary ischemia.
A prospective, observational trial was performed in 8 participating medical centers. Serial blood samples were obtained on presentation to the ED and 3 and 6 hours later. The cTnT whole-blood rapid assays were performed immediately at the site. Treating physicians and patients were blinded to the results of the rapid assays. Serum samples were analyzed at the core laboratory for serum cTnT, creatine kinase (CK)-MB, and myoglobin. The sensitivity of the rapid assay for detecting acute myocardial infarction (AMI) was compared with the sensitivities of serum cTnT, CK-MB, and myoglobin assays.
Of 721 patients, 102 were diagnosed as having AMI. The median elapsed time from symptom onset to ED arrival was 3 hours. The sensitivities of the rapid assay for detecting AMI were 19.6%, 59.0%, and 69.7% at 0, 3, and 6 hours, respectively. The sensitivities of the serum cTnT assay (p-values for comparison with the rapid assay for cTnT) were 25.0% (p = 0.18), 69.6% (p = 0.04), and 79.8% (p = 0.02) at 0, 3, and 6 hours, respectively. The CK-MB and myoglobin sensitivities were 21.9%, 64.5%, and 81.0%; and 43.8%, 77.4%, and 71.4%, respectively. There were 7 patients with AMI who had negative rapid assay readings and positive serum cTnT levels; 4 of these patients were enrolled at the same site. Twenty patients not diagnosed as having AMI had at least one positive rapid assay. Fourteen of these 20 patients had a diagnosis of clinically relevant cardiac disease.
The sensitivity of this whole-blood rapid cTnT assay for detecting AMI is comparable to that of current serum assays and offers the advantage of providing rapid bedside results. Discrepancies between serum and whole-blood assays for cTnT noted in this study may indicate the need for further education for the test reader prior to patient use.
评估一种新型床旁全血心肌肌钙蛋白T（cTnT）快速检测法在因急性冠状动脉缺血症状就诊于急诊科患者中的性能。
在8个参与研究的医疗中心进行了一项前瞻性观察性试验。患者就诊于急诊科时、3小时后和6小时后采集系列血样。cTnT全血快速检测在现场立即进行。治疗医生和患者对快速检测结果不知情。血清样本在核心实验室分析血清cTnT、肌酸激酶（CK）-MB和肌红蛋白。将快速检测法检测急性心肌梗死（AMI）的敏感性与血清cTnT、CK-MB和肌红蛋白检测法的敏感性进行比较。
721例患者中，102例被诊断为AMI。从症状发作到抵达急诊科的中位时间为3小时。快速检测法在0小时、3小时和6小时检测AMI的敏感性分别为19.6%、59.0%和69.7%。血清cTnT检测法（与cTnT快速检测法比较的p值）在0小时、3小时和6小时的敏感性分别为25.0%（p = 0.18）、69.6%（p = 0.04）和79.8%（p = 0.02）。CK-MB和肌红蛋白的敏感性分别为21.9%、64.5%和81.0%；以及43.8%、77.4%和71.4%。有7例AMI患者快速检测结果为阴性但血清cTnT水平为阳性；其中4例患者在同一地点入组。20例未被诊断为AMI的患者至少有一次快速检测结果为阳性。这20例患者中有14例被诊断为有临床相关性心脏病。
这种全血快速cTnT检测法检测AMI的敏感性与目前的血清检测法相当，并具有在床旁快速提供结果的优势。本研究中血清和全血cTnT检测结果的差异可能表明在患者使用前需要对检测结果解读人员进行进一步培训。
