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用于排除血栓形成的快速酶联免疫吸附法、比浊法和凝集法D-二聚体检测的不同准确性:对疑似深静脉血栓形成和肺栓塞门诊患者诊断检查的影响。

Different accuracies of rapid enzyme-linked immunosorbent, turbidimetric, and agglutination D-dimer assays for thrombosis exclusion: impact on diagnostic work-ups of outpatients with suspected deep vein thrombosis and pulmonary embolism.

作者信息

Michiels Jan J, Gadisseur Alain, van der Planken Marc, Schroyens Wilfried, De Maeseneer Marianne, Hermsen Jan T, Trienekens Paul H, Hoogsteden Henk, Pattynama Peter M P

机构信息

Hemostasis and Thrombosis Research, Department of Hematology, University Hospital Antwerp, Belgium.

出版信息

Semin Thromb Hemost. 2006 Oct;32(7):678-93. doi: 10.1055/s-2006-951296.

DOI:10.1055/s-2006-951296
PMID:17024595
Abstract

The requirement for a safe diagnostic strategy should be based on an overall posttest incidence of venous thromboembolism (VTE) of less than 1%, with a negative predictive value of more than 99 to 100% during 3-month follow-up. Compression ultrasonography (CUS) and spiral computed tomography (CT) currently are the methods of choice to confirm or rule out deep venous thrombosis (DVT) and pulmonary embolism (PE), respectively. CUS has a negative predictive value (NPV) of 97 to 98%, indicating the need to improve the diagnostic work-up of patients with suspected DVT by clinical score assessment and D-dimer testing. Spiral CT as a stand-alone method detects all clinically relevant PEs and a large number of alternative diagnoses. It rules out PE with a NPV of 98 to 99%. Spiral CT is expensive, emphasizing the need to improve the diagnostic work-up of patients with suspected PE by the use of clinical score assessment and D-dimer testing. Clinical score assessment for DVT and PE has not safely ruled out VTE in multicenter studies and in routine daily practices. Modification of the Wells clinical score assessment for DVT by elimination of the "minus 2 points" for alternative diagnosis will improve the reproducibility of the clinical score assessment. The combination of a first negative CUS and a negative SimpliRed or an enzyme-linked immunosorbent assay (ELISA) VIDAS D-dimer of < 1,000 ng/mL safely exclude DVT (NPV > 99%) irrespective of clinical score assessment and without the need to repeat CUS in approximately 60 to 70% of patients. The rapid quantitative and qualitative agglutination D-dimer assays for the exclusion of VTE are not sensitive enough as stand-alone tests and should be used in combination with clinical score assessment. A normal rapid ELISA VIDAS D-dimer test as a stand-alone test safely excludes DVT and PE, with a NPV of 99 to 100%, irrespective of clinical score, without the need of CUS or spiral CT. The combined strategy of a rapid ELISA VIDAS D-dimer followed by objective testing with CUS for DVT and by spiral CT for PE will reduce the need for noninvasive imaging techniques by 40 to 50%.

摘要

安全诊断策略的要求应以静脉血栓栓塞症(VTE)的总体检测后发病率低于1%为基础,在3个月的随访期间阴性预测值超过99%至100%。目前,加压超声检查(CUS)和螺旋计算机断层扫描(CT)分别是确诊或排除深静脉血栓形成(DVT)和肺栓塞(PE)的首选方法。CUS的阴性预测值(NPV)为97%至98%,这表明需要通过临床评分评估和D-二聚体检测来改进疑似DVT患者的诊断检查。螺旋CT作为一种独立的方法可检测出所有临床相关的PE以及大量其他诊断结果。它排除PE的NPV为98%至99%。螺旋CT费用昂贵,这凸显了通过使用临床评分评估和D-二聚体检测来改进疑似PE患者诊断检查的必要性。在多中心研究和日常实践中,DVT和PE的临床评分评估未能安全地排除VTE。通过消除替代诊断的“减2分”来修改Wells DVT临床评分评估将提高临床评分评估的可重复性。首次CUS结果为阴性且SimpliRed或酶联免疫吸附测定(ELISA)VIDAS D-二聚体<1000 ng/mL的组合可安全排除DVT(NPV>99%),无论临床评分评估如何,并且在大约60%至70%的患者中无需重复CUS。用于排除VTE的快速定量和定性凝集D-二聚体检测作为独立检测方法不够敏感,应与临床评分评估结合使用。正常的快速ELISA VIDAS D-二聚体检测作为独立检测方法可安全排除DVT和PE,NPV为99%至100%,无论临床评分如何,无需CUS或螺旋CT。先进行快速ELISA VIDAS D-二聚体检测,然后针对DVT进行CUS客观检测以及针对PE进行螺旋CT检测的联合策略将减少40%至50%对非侵入性成像技术的需求。

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