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新型抗原酶联免疫吸附试验评估。

Evaluation of a Novel Antigen Enzyme-Linked Immunosorbent Assay.

机构信息

Max von Pettenkofer-Institut für Hygiene und Medizinische Mikrobiologie, Medizinische Fakultät, LMU München, Munich, Germany.

Sektion Klinische Infektiologie, Medizinische Klinik und Poliklinik IV, Klinikum der Universität, LMU München, Munich, Germany.

出版信息

J Clin Microbiol. 2019 Jun 25;57(7). doi: 10.1128/JCM.00136-19. Print 2019 Jul.

DOI:10.1128/JCM.00136-19
PMID:31018980
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6595454/
Abstract

Invasive aspergillosis (IA) is a life-threatening infection that mainly occurs in immunocompromised patients. Here, we compared the novel -specific galactomannoprotein (GP) enzyme-linked immunosorbent assay (ELISA) (Euroimmun Medizinische Labordiagnostika AG) to the established Platelia galactomannan (GM) ELISA (Bio-Rad Laboratories) for the detection of IA. A total of 267 serum samples from 45 cases of proven and 4 episodes of probable IA (according to European Organization for Research and Treatment of Cancer/Invasive Fungal Infections Cooperative Group and the National Institute of Allergy and Infectious Diseases Mycoses Study Group [EORTC/MSG] criteria) and 156 sera from patients without evidence of IA were tested. Pearson's correlation statistics, as well as sensitivity and specificity, were calculated using manufacturer-recommended (GM) or optimized (GP) cutoff levels. was found in 88% of culture-positive infections. When we analyzed all 423 serum samples, GM and GP tests correlated strongly ( = 0.82,  < 0.0001). Among proven IA cases using samples obtained as closely as possible to the day of proven diagnosis, the sensitivity for both tests was 40%. All cases of probable IA (defined by positive GM testing) were also GP positive. Concordant results of the two ELISAs were obtained in 43 of 49 samples (88%). Extending measurements to all sera available in the time frame of 7 days prior to 7 days after the day of proven diagnosis, 47% and 56% of the cases were detected by the GM and GP tests, respectively. Specificity was 99% for GM and 96% for GP testing. For the diagnosis of IA, sensitivity and specificity of the novel GP ELISA are similar to those of the Platelia GM ELISA. The low sensitivities of both tests underline the need for serial testing in patients at risk for IA.

摘要

侵袭性曲霉病(IA)是一种危及生命的感染,主要发生在免疫功能低下的患者中。在这里,我们比较了新型半乳甘露聚糖(GP)酶联免疫吸附试验(Euroimmun Medizinische Labordiagnostika AG)和已建立的曲霉半乳甘露聚糖(GM)酶联免疫吸附试验(Bio-Rad Laboratories)在检测 IA 中的作用。共检测了 45 例确诊和 4 例疑似侵袭性曲霉病(根据欧洲癌症研究与治疗组织/侵袭性真菌感染合作组和美国国立过敏和传染病研究所霉菌病研究组[EORTC/MSG]标准)的 45 例患者和 156 例无 IA 证据的患者的 267 份血清样本。使用制造商推荐(GM)或优化(GP)截断值计算 Pearson 相关统计数据以及敏感性和特异性。在 88%的培养阳性感染中发现。当我们分析所有 423 份血清样本时,GM 和 GP 检测相关性很强( = 0.82,  < 0.0001)。在使用尽可能接近确诊日获得的样本分析所有确诊的 IA 病例时,两种检测方法的敏感性均为 40%。所有可能的 IA 病例(定义为 GM 检测阳性)也是 GP 阳性。两种 ELISA 的结果在 49 份样本中的 43 份中一致(88%)。在确诊日前后 7 天的时间范围内扩展测量,GM 和 GP 检测分别检测到 47%和 56%的病例。GM 检测的特异性为 99%,GP 检测的特异性为 96%。对于 IA 的诊断,新型 GP ELISA 的敏感性和特异性与 Platelia GM ELISA 相似。两种检测方法的敏感性均较低,这突出表明需要对 IA 高危患者进行连续检测。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5010/6595454/5adcf11b08f7/JCM.00136-19-f0006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5010/6595454/5c7f4b03058a/JCM.00136-19-f0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5010/6595454/4cea5313a289/JCM.00136-19-f0002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5010/6595454/01fef4aaea92/JCM.00136-19-f0003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5010/6595454/56452e9166d3/JCM.00136-19-f0004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5010/6595454/8ea08bfa139d/JCM.00136-19-f0005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5010/6595454/5adcf11b08f7/JCM.00136-19-f0006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5010/6595454/5c7f4b03058a/JCM.00136-19-f0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5010/6595454/4cea5313a289/JCM.00136-19-f0002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5010/6595454/01fef4aaea92/JCM.00136-19-f0003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5010/6595454/56452e9166d3/JCM.00136-19-f0004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5010/6595454/8ea08bfa139d/JCM.00136-19-f0005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5010/6595454/5adcf11b08f7/JCM.00136-19-f0006.jpg

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