Curtin N, Highe G, Harris M, Braunstein A, Demattia F, Coss L
Hospital Consolidated Laboratory, Providence Hospital, Southfield, Michigan 48075, USA.
Lab Hematol. 2004;10(2):88-94. doi: 10.1532/LH96.04018.
The clinical diagnosis of venous thromboembolism (VTE), which includes both deep vein thrombosis (DVT) and pulmonary embolism (PE), is often difficult and requires a number of imaging tests plus clinical assessment. It is now accepted that pretest clinical probability of disease plus a sensitive, quantitative D-Dimer assay can be used to reliably exclude VTE. In design of diagnostic strategies for VTE it is recommended that the D-Dimer assay be evaluated for sensitivity and specificity in well-designed, blinded studies using a cohort of patients for whom the assay will ultimately be used. Therefore we evaluated the IL Test D-Dimer on the ACL 9000 automated coagulation analyzer for its sensitivity and specificity in the diagnosis of VTE. A total of 512 patients admitted to the emergency department of Providence Hospital with suspected VTE were included in the dataset. Our aim was to find the clinically meaningful IL Test D-Dimer cutoff value, which would give us 100% sensitivity and the highest possible specificity for exclusion of VTE. Patients were categorized clinically into low, medium, or high pretest probability and had computed tomographic and/or ventilation-perfusion scans for investigation of PE and ultrasound studies for suspected DVT, with the laboratory blinded to the clinical findings. Of the 511 patients, 28 (5.4%) had confirmed VTE (PE and/or DVT) based on imaging and clinical studies. Applying receiver operating characteristic curve (ROC) analysis, we determined from our study that a cutoff value of 237 ng/mL IL Test D-Dimer gave a 100% sensitivity with a specificity of 38% for detection of VTE. The findings demonstrate that a diagnostic strategy using the IL Test D-Dimer assay as a first-line test in combination with pretest probability is safe and can be used in patients with suspected VTE. In conclusion, patient analysis results indicating low or moderate pretest probability for VTE and a negative IL Test D-Dimer (cutoff value of 237 ng/mL) assay result on the ACL 9000 reliably exclude VTE (both PE and DVT). We expect that inclusion of the rapid IL Test D-Dimer assay for assessment of suspected VTE in the emergency department at Providence will result in improved patient diagnosis and therapy, reduction in unnecessary radiological investigations, and lowering of overall costs associated with investigation of patients suspected of having VTE disease.
静脉血栓栓塞症（VTE）包括深静脉血栓形成（DVT）和肺栓塞（PE），其临床诊断通常很困难，需要多项影像学检查以及临床评估。目前公认，疾病的预测试临床概率加上敏感的定量D-二聚体检测可用于可靠地排除VTE。在设计VTE的诊断策略时，建议在精心设计的、盲法研究中，使用最终将采用该检测方法的患者队列，对D-二聚体检测的敏感性和特异性进行评估。因此，我们在ACL 9000自动凝血分析仪上评估了IL检测D-二聚体在VTE诊断中的敏感性和特异性。数据集纳入了普罗维登斯医院急诊科收治的512例疑似VTE患者。我们的目的是找到具有临床意义的IL检测D-二聚体临界值，该临界值将为我们提供100%的敏感性以及排除VTE的尽可能高的特异性。患者在临床上被分为低、中或高预测试概率组，并接受计算机断层扫描和/或通气灌注扫描以检查PE，以及接受超声检查以排查疑似DVT，实验室对临床结果不知情。在这511例患者中，28例（5.4%）经影像学和临床研究确诊为VTE（PE和/或DVT）。应用受试者工作特征曲线（ROC）分析，我们从研究中确定，IL检测D-二聚体临界值为237 ng/mL时，检测VTE的敏感性为100%，特异性为38%。研究结果表明，将IL检测D-二聚体检测作为一线检测方法并结合预测试概率的诊断策略是安全的，可用于疑似VTE的患者。总之，患者分析结果显示VTE预测试概率低或中等，且ACL 9000上的IL检测D-二聚体检测结果为阴性（临界值为237 ng/mL），可可靠地排除VTE（包括PE和DVT）。我们预计，在普罗维登斯医院急诊科将快速IL检测D-二聚体检测纳入疑似VTE的评估，将改善患者的诊断和治疗，减少不必要的影像学检查，并降低与疑似VTE疾病患者检查相关的总体成本。
