a Emergency Department , Hospital de Sant Pau , Barcelona , Spain.
b Cardiology Department, Acute and Intensive Cardiac Care Unit, IIB-Sant Pau, CIBER-CV , Hospital de la Santa Creu i Sant Pau , Barcelona , Spain.
Crit Rev Clin Lab Sci. 2017 Nov-Dec;54(7-8):551-571. doi: 10.1080/10408363.2017.1410777. Epub 2017 Dec 11.
Twenty-five years ago, non-isotopic immunoassays for measuring the cardiac specific isoforms of troponin I (cTnI) and T (cTnT) were developed. Both biomarkers radically changed the diagnosis, prognosis, and therapy indication of acute coronary syndromes (ACS) and, particularly, of myocardial infarction (MI). However, cardiac troponins (cTn) rapidly demonstrated their usefulness in other cardiac and non-cardiac conditions, a part of the ischemic coronary diseases. Consequently, the number of patients to be tested for cTn and the number of tests requested to clinical laboratories sharply increased. Though the manufacturers continuously improved the analytical characteristics of the first cTn assays and produced different cTn assay "generations", the universal definition of myocardial infarction required less-than-available analytical imprecision at the cTn concentration used to assess MI (i.e. the 99th reference percentile). To address the clinical requirements, manufacturers developed the high-sensitivity cTn (hs-cTn) assays that allow to measure the 99th reference percentile with adequate precision, to detect cTn in many healthy subjects and, hence, to calculate the hs-cTn biological variation and especially to observe in very short time intervals serial differences in hs-cTn attributable to cardiac ischemia. Since the number of patients attending the emergency departments (ED) for a suspected ACS or MI is increasing, the improved properties of hs-cTn assays, allowing faster and safer patient assessment, will help to alleviate the sometimes overcrowded EDs. However, there are many biological, analytical, and clinical factors that can influence the true hs-cTn values of a patient. Clinicians and laboratory professionals should know about them for the best interpretation of the otherwise largely useful hs-cTn measurements. In conclusion, 25 years after their introduction for clinical use, "cTn are still on the stage and improving their clinical value".
25 年前,人们开发了用于测量心肌肌钙蛋白 I(cTnI)和 T(cTnT)心脏特异性同工型的非同位素免疫测定法。这两种生物标志物极大地改变了急性冠状动脉综合征(ACS)的诊断、预后和治疗指征,尤其是心肌梗死(MI)的诊断、预后和治疗指征。然而,心肌肌钙蛋白(cTn)很快在其他心脏和非心脏疾病中显示出其用途,其中一部分是缺血性冠状动脉疾病。因此,需要对 cTn 进行测试的患者数量以及临床实验室要求进行的测试数量急剧增加。尽管制造商不断改进第一代 cTn 检测的分析特性,并生产出不同的 cTn 检测“代”产品,但心肌梗死的通用定义要求用于评估 MI 的 cTn 浓度(即第 99 个参考百分位数)的分析不精密度要低于可用水平。为满足临床需求,制造商开发了高敏心肌肌钙蛋白(hs-cTn)检测法,该检测法可以以足够的精密度测量第 99 个参考百分位数,在许多健康受试者中检测到 cTn,从而计算 hs-cTn 的生物学变异,特别是可以在非常短的时间间隔内观察到与心肌缺血相关的 hs-cTn 的连续差异。由于因疑似 ACS 或 MI 而到急诊科就诊的患者数量正在增加,hs-cTn 检测法的改进特性可以更快、更安全地评估患者,这将有助于缓解急诊科有时过于拥挤的情况。然而,有许多生物学、分析和临床因素会影响患者的真实 hs-cTn 值。临床医生和实验室专业人员应该了解这些因素,以便更好地解释 hs-cTn 的测量结果。总之,在引入临床应用 25 年后,“cTn 仍在不断发展,提高其临床价值”。