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首页> 外文期刊>Emergency medicine journal: EMJ >Comparison of the Simplify D-dimer assay performed at the bedside with a laboratory-based quantitative D-dimer assay for the diagnosis of pulmonary embolism in a low prevalence emergency department population.
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Comparison of the Simplify D-dimer assay performed at the bedside with a laboratory-based quantitative D-dimer assay for the diagnosis of pulmonary embolism in a low prevalence emergency department population.

机译：在床边进行的简化D-二聚体测定法与基于实验室的定量D-二聚体测定法在诊断低流行急诊科人群中肺栓塞的诊断中的比较。

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BACKGROUND: The immunofiltration D-dimer assay could allow point-of-care testing for pulmonary embolism (PE). A study was undertaken to compare a clinician-performed qualitative D-dimer assay with the automated quantitative D-dimer test. METHODS: A prospective observational study was conducted from January to October 2005 at an urban academic emergency department (ED). 1193 patients of mean (SD) age 47 (16) years (66% female) were enrolled. The study protocol combined pretest probability estimation, D-dimer testing by both a qualitative immunochromatographic assay (Simplify) performed at the point of care by 192 different clinicians and a quantitative D-dimer test performed in a CLIA-certified laboratory. The criterion standard was image-proven PE or deep venous thrombosis within 45 days after enrollment. To test interobserver agreement for the qualitative assay, two blinded observers independently read 841 Simplify cartridges. RESULTS: Of 1193 patients enrolled, 45 were PE+ (3.8%, 95% CI 2.8% to 5.0%). Qualitative results were available for 1169 (98%) and quantitative results were available for 1136 (95%). Comparison of the qualitative and quantitative D-dimer tests gave the following results: sensitivity 91% (95% CI 78% to 98%) vs 93% (95% CI 80% to 98%); specificity 57% (95% CI 54% to 60%) vs 57% (95% CI 54% to 60%); likelihood ratio negative 0.16 (95% CI 0.06 to 0.37) vs 0.13 (95% CI 0.05 to 0.35). The weighted Cohen's kappa for interpretation of the qualitative assay was 0.69 (95% CI 0.63 to 0.76). CONCLUSIONS: In this very low-risk ED population, a qualitative D-dimer assay performed at the point of care had similar diagnostic accuracy to the quantitative D-dimer test. Interobserver agreement for the qualitative test was good.
机译：背景：免疫过滤D-二聚体测定法可用于肺栓塞（PE）的即时检测。进行了一项研究，以比较临床医生进行的定性D-二聚体测定与自动定量D-二聚体检测。方法：前瞻性观察研究于2005年1月至10月在城市学术急诊科（ED）进行。纳入1193名平均（SD）年龄47岁（16）岁的患者（女性占66％）。该研究方案结合了前测概率估计，通过192个不同临床医生在护理点进行的定性免疫色谱分析（Simplify）进行的D-二聚体测试以及在CLIA认证的实验室中进行的定量D-二聚体测试。标准的标准是入选后45天内经影像验证的PE或深静脉血栓形成。为了测试观察者之间的定性分析一致性，两名不知情的观察者独立阅读了841个简化药筒。结果：在1193名患者中，有45名是PE +（3.8％，95％CI 2.8％至5.0％）。定性结果可用于1169（98％），定量结果可用于1136（95％）。定性和定量D-二聚体测试的比较得出以下结果：灵敏度91％（95％CI为78％至98％）对93％（95％CI为80％至98％）;特异性57％（95％CI 54％至60％）对57％（95％CI 54％至60％）;可能性比为负0.16（95％CI为0.05至0.35），为0.16（95％CI为0.06至0.37）。用于解释定性分析的加权Cohenκ为0.69（95％CI为0.63至0.76）。结论：在这种极低风险的ED人群中，在护理时进行的定性D-二聚体测定具有与定量D-二聚体检测相似的诊断准确性。观察员之间对定性测试的协议很好。

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