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Optimization of the cutoff value for the Aspergillus double-sandwich enzyme immunoassay.

机译:曲霉双夹心酶免疫分析临界值的优化。

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摘要

BACKGROUND: Many health care centers worldwide use the Platelia Aspergillus enzyme immunoassay (PA-EIA; Bio-Rad Laboratories) for diagnosis of invasive aspergillosis (IA). A cutoff optical density (OD) index of 1.5 was originally recommended by the manufacturer, but in practice, most institutions use lower cutoff values. Moreover, a cutoff OD index of 0.5 was recently approved in the United States. In the present study, we set out to optimize the cutoff level by performing a retrospective analysis of PA-EIA values for samples that had been obtained prospectively from adult patients at risk for IA at 2 European health care centers. METHODS: In total, 239 treatment episodes were included of which there were 19 episodes of proven IA and 19 episodes of probable IA. Per-episode and per-test analyses and receiver operating characteristic curves were used to determine the optimal cutoff value. RESULTS: In the per-episode analysis, lowering the cutoff OD index for positivity from 1.5 to 0.5 increased the overall sensitivity by 21% (from 76.3% to 97.4%) but decreased the overall specificity by 7% (from 97.5% to 90.5%). Requiring 2 consecutive samples with an OD index or = 0.5 resulted in the highest test accuracy, with an improved positive predictive value. At a cutoff OD index of 0.5, the antigen test result was positive during the week before conventional diagnosis in 65% of cases and during the week of diagnosis in 79.5% of cases. CONCLUSIONS: A cutoff OD index of 0.5--identical to the approved cutoff in the United States--improves the overall performance of the PA-EIA for adult hematology patients.
机译:背景:全球许多医疗保健中心都使用Platelia曲霉酶免疫分析法(PA-EIA; Bio-Rad实验室)来诊断侵袭性曲霉病(IA)。最初,制造商建议使用1.5的截止光密度(OD)指数,但实际上,大多数机构使用较低的截止值。而且,最近在美国批准了OD极限值为0.5。在本研究中,我们着手对2个欧洲卫生保健中心前瞻性地从患有IA风险的成年患者中获得的样本进行PA-EIA值的回顾性分析,以优化截止水平。方法:总共包括239例治疗发作,其中19例经证实的IA和19例可能的IA。每集和每项测试分析以及接收器工作特性曲线用于确定最佳截止值。结果:在每集分析中,将阳性的截止OD指数从1.5降低到0.5可将总体敏感性提高21%(从76.3%降低至97.4%),但将整体特异性降低7%(从97.5%降低至90.5%) )。要求连续2个样品的OD指数>或= 0.5导致最高的测试准确性,并具有更高的阳性预测值。在临界OD值为0.5时,常规诊断前一周的抗原检测结果为阳性(65%),诊断周为79.5%。结论:临界OD指数为0.5(与美国批准的临界值相同)改善了成人血液学患者PA-EIA的总体性能。

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