Pernod Gilles, Wu Haifeng, de Maistre Emmanuel, Lazarchick John, Kassis Jeannine, Aguilar Carlos, Vera Pascual M, Palareti Gualtiero, D'Angelo Armando
aDepartment of Vascular Medicine, Grenoble University Hospital, Grenoble, France bPathology and Laboratory Medicine, Ohio State University, Columbus, Ohio, USA cHematology Laboratory, University Hospital, Dijon, France dPathology and Laboratory Medicine, Medical University South Carolina, Charleston, South Carolina, USA eDepartment of Haematology, Hôpital Maisonneuve-Rosemont, University of Montreal, Montreal, Canada fDepartment of Haematology, Santa Barbara General Hospital, Soria gLaboratio de Coagulación, Centro Sanitario Hospital General Universitario de Alicante, Alicante, Spain hDepartment of Angiology and Blood Coagulation 'Marino Golinelli', Bologna University Hospital Corporation, Policlinica S. Orsola Malpighi, Bologna iCoagulation Service and Thrombosis Research Unit, Scientific Institute San Raffaele, Milano, Italy.
Blood Coagul Fibrinolysis. 2017 Apr;28(3):254-260. doi: 10.1097/MBC.0000000000000591.
: Combined clinical pretest probability (PTP) and D-dimer testing have great diagnostic value for pulmonary embolism exclusion. To harmonize performance levels of D-dimer assays available on the market, the Clinical and Laboratory Standard Institute (CLSI) has published a guideline, endorsed by the US Food and Drug Administration (FDA). Such guideline specifies the ideal D-dimer assay characteristic and target population. This study was conducted following the CLSI guideline to upgrade the assay-intended use and obtain FDA clearance of STA-Liatest D-Di assay for pulmonary embolism exclusion in patient with low/moderate PTP. This was an international, multicenter, prospective nonrandomized, noninterventional clinical outcome management study conducted in a standard of care setting. D-dimer assay was performed in consecutive, ambulatory outpatients suspected of pulmonary embolism, with low/moderate PTP, and without medical conditions or in clinical settings known to alter default D-dimer values regardless of the presence of thrombosis using a threshold of 0.5 μg/ml (fibrinogen equivalent units) for venous thromboembolism exclusion. Results were used to determine test performance. Of 1141 patients who underwent D-dimer testing, 1060 had valid results and completed study as planned. STA-Liatest D-Di assay performance has exceeded the CLSI/FDA guidance requirements, with a sensitivity of 97.6% (95% confidence interval: 91.7-99.7%) and a negative predictive value of 99.7% (95% confidence interval: 99.0-100%). STA-Liatest D-Di assay has an excellent performance when used in combination with a PTP score in relevant patients and has the potential to minimize the economic healthcare burden avoiding unnecessary and expensive imaging tests.
临床预测试概率（PTP）与D - 二聚体检测相结合对排除肺栓塞具有重要诊断价值。为使市场上可用的D - 二聚体检测方法的性能水平达到一致，临床和实验室标准协会（CLSI）发布了一项指南，并得到了美国食品药品监督管理局（FDA）的认可。该指南规定了理想的D - 二聚体检测方法的特性和目标人群。本研究遵循CLSI指南进行，以提升检测的预期用途，并获得FDA对STA - Liatest D - Di检测方法用于排除低/中度PTP患者肺栓塞的许可。这是一项在标准护理环境下进行的国际、多中心、前瞻性非随机、非干预性临床结局管理研究。对连续的、怀疑患有肺栓塞、PTP低/中度、无已知会改变默认D - 二聚体值的疾病状况或临床情况（无论是否存在血栓形成）的门诊患者进行D - 二聚体检测，使用0.5μg/ml（纤维蛋白原当量单位）的阈值排除静脉血栓栓塞。结果用于确定检测性能。在接受D - 二聚体检测的1141例患者中，1060例有有效结果并按计划完成研究。STA - Liatest D - Di检测方法的性能已超过CLSI/FDA指南要求，敏感性为97.6%（95%置信区间：91.7 - 99.7%），阴性预测值为99.7%（95%置信区间：99.0 - 100%）。STA - Liatest D - Di检测方法与相关患者的PTP评分联合使用时具有出色的性能，并且有可能减轻经济医疗负担，避免不必要且昂贵的影像学检查。
