Dakshi Ahmed, Hatherley James, Collinson Paul, Phillips Suzannah, Bailey Lisa, Miller Guy, Shaw Matthew, Khand Aleem
Department of Cardiology, Liverpool University Hospital NHS Foundation Trust, Liverpool, UK.
Institute of Ageing and Chronic Diseases, University of Liverpool, Liverpool, UK.
Clin Chem Lab Med. 2024 Sep 2. doi: 10.1515/cclm-2024-0138.
The objective of this study is to evaluate the analytical and diagnostic performance of a high-sensitivity point-of-care (POC) cardiac troponin I assay, the Quidel TriageTrue™ (QuidelOrtho Inc, San Diego, USA), compared to central laboratory testing (CLT) in accelerated diagnostic protocols (ADP) in real time in a clinical environment.
In a nested sub-study of a pragmatic randomised control trial, consecutive patients with suspected acute coronary syndrome (ACS) and chest pain <12 h duration were randomised to the ESC 0/1 and 0/3-h ADP. Subjects underwent sampling for Quidel TriageTrue POC hs-TnI whole blood and plasma, CLT hs-TnT Roche Elecsys and a validated, NICE approved CLT High sensitivity cardiac troponin I (hs-TnI) (Siemens Attellica) at each time point. Assay imprecision was assessed by repeat analysis of whole blood samples at three levels (low, near 10 % CV 5-10 ng/L, medium, approximating 99th percentile 15-25 ng/L and high, 3-5 times the 99th percentile, 60-100 ng/L). Final diagnosis was adjudicated at 6 weeks by Roche hs-TnT using the 4th universal definition of myocardial infarction (MI).
A total of 1,157 patients consented and had both investigational POC whole blood and plasma and central lab hs-cTn available. The median age was 59, 47.2 % were female and 15 % had suffered a previous MI. Assay imprecision of whole blood POC TriageTrue revealed 10 % CV at 8.6 ng/L (>50 % lower than 99th percentile [20.5 ng/L]) and a 20 % CV at 1.2 ng/L. Receiver operator characteristics (ROC) curves were computed for each assay against adjudicated index type 1 MI to study clinical performance. At all-time points there were excellent performance for whole blood POC TriageTrue: area under the curve (AUC) 0.97 [95 % CI 0.94-098], 0.98 [95 % CI 0.97-1.00] and 0.95 [95 % CI 0.92-0.98] at time 0, 1 and 3 h respectively. There was statistical equivalence for performance of whole blood and plasma POC TriageTrue hs-TnI and laboratory Siemens Atellica hs-TnI.
The whole blood POC TriageTrue hs-TnI assay demonstrates imprecision levels consistent with high sensitivity characteristics and has a clinical performance equivalent to an established, validated and NICE approved laboratory Siemens Atellica hs-TnI.
本研究的目的是在临床环境中，将一种高灵敏度即时检测（POC）心肌肌钙蛋白I检测方法（Quidel TriageTrue™，美国圣地亚哥的QuidelOrtho公司）与中心实验室检测（CLT）在加速诊断方案（ADP）中进行实时比较，评估其分析和诊断性能。
在一项实用随机对照试验的嵌套子研究中，将连续的疑似急性冠状动脉综合征（ACS）且胸痛持续时间<12小时的患者随机分配至ESC 0/1和0/3小时ADP。在每个时间点，受试者接受Quidel TriageTrue POC hs-TnI全血和血浆、CLT hs-TnT罗氏电化学发光免疫分析仪以及经过验证、英国国家卫生与临床优化研究所（NICE）批准的CLT高灵敏度心肌肌钙蛋白I（hs-TnI）（西门子Atellica）检测的样本采集。通过对三个水平（低水平，CV接近10%，5-10 ng/L；中等水平，接近第99百分位数，15-25 ng/L；高水平，第99百分位数的3-5倍，60-100 ng/L）的全血样本进行重复分析来评估检测不精密度。在6周时，使用心肌梗死（MI）的第4版通用定义，通过罗氏hs-TnT判定最终诊断。
共有1157名患者同意参与研究，并同时提供了研究用POC全血和血浆样本以及中心实验室hs-cTn样本。患者的中位年龄为59岁，47.2%为女性，15%曾患过MI。全血POC TriageTrue检测的不精密度显示，在8.6 ng/L时CV为10%（比第99百分位数[20.5 ng/L]低>50%），在1.2 ng/L时CV为20%。针对判定的1型MI，计算每种检测方法的受试者工作特征（ROC）曲线以研究临床性能。在所有时间点，全血POC TriageTrue均表现出色：在0、1和3小时时，曲线下面积（AUC）分别为0.97 [95% CI 0.94-0.98]、0.98 [95% CI 0.97-1.00]和0.95 [95% CI 0.92-0.98]。全血和血浆POC TriageTrue hs-TnI与实验室西门子Atellica hs-TnI的性能在统计学上具有等效性。
全血POC TriageTrue hs-TnI检测方法显示出与高灵敏度特征一致的不精密度水平，并且其临床性能与已确立、经过验证且获得NICE批准的实验室西门子Atellica hs-TnI相当。
