两种不同（1,3）-β-d-葡聚糖检测方法用于侵袭性真菌感染诊断的临床评估：一项回顾性队列研究。

Clinical evaluation of two different (1,3)-ß-d-glucan assays for diagnosis of invasive fungal diseases: A retrospective cohort study.

机构信息

Institute for Infectious Diseases and Infection Control, Jena University Hospital/Friedrich-Schiller-University, Jena, Germany.

Mikrobiologisches Institut - Klinische Mikrobiologie, Immunologie und Hygiene, Universitätsklinikum Erlangen und Friedrich-Alexander-Universität (FAU) Erlangen-Nürnberg, Erlangen, Germany.

出版信息

Mycoses. 2021 Feb;64(2):212-219. doi: 10.1111/myc.13207. Epub 2020 Nov 22.

DOI:10.1111/myc.13207

PMID:33156525

Abstract

BACKGROUND

Early diagnosis of invasive fungal diseases (IFDs) remains a major challenge in routine clinical practice.

OBJECTIVES

The aim of this retrospective cohort study was to evaluate the diagnostic performance of the fungal biomarker (1,3)-ß-d-glucan (BDG) using the β-Glucan test (GT) and the well-established Fungitell assay® (FA) in real-life clinical practice.

PATIENTS/METHODS: We included 109 patients with clinical suspicion of IFD who were treated at Jena University Hospital, Germany, between November 2018 and March 2019. The patients were classified according to the latest update of the EORTC/MSG consensus definitions of IFD. The first serum sample of every patient was analysed for BDG using the FA and the GT, respectively.

RESULTS

Fifty-six patients (51.4%) had at least one host factor for IFD. In patients with proven (n = 11) or probable IFDs (n = 20), median BDG concentrations were 145.0 pg/ml for the FA and 5.1 pg/ml for the GT, respectively. A positive test result of both BDG assays at manufacturer's cut-offs predicted 89.5%-98.3% of proven or probable IFD, but the sensitivity of both assays was limited: The FA identified 60.7% of IFDs (cut-off: 80 pg/ml). Reducing the GT cut-off value from 11.0 to 4.1 pg/ml increased the detection rate of IFDs from 35.5% to 54.8%.

CONCLUSIONS

A positive test result of both BDG assays at manufacturer's cut-off was highly predictive for IFD, but except for Pneumocystis jirovecii pneumonia sensitivities were limited. Adjustment of the GT cut-off value equalised sensitivities of GT and FA.

摘要

背景

侵袭性真菌病（IFD）的早期诊断在常规临床实践中仍然是一个主要挑战。

目的

本回顾性队列研究旨在评估真菌生物标志物（1,3）-β-d-葡聚糖（BDG）在实际临床实践中使用 β-葡聚糖检测（GT）和成熟的 Fungitell 检测（FA）的诊断性能。

患者/方法：我们纳入了 2018 年 11 月至 2019 年 3 月在德国耶拿大学医院就诊的 109 例有 IFD 临床疑似症状的患者。患者根据 IFD 的 EORTC/MSG 共识定义的最新更新进行分类。每位患者的第一份血清样本分别使用 FA 和 GT 分析 BDG。

结果

56 例患者（51.4%）至少存在一个 IFD 的宿主因素。在确诊（n=11）或可能 IFD（n=20）患者中，FA 的 BDG 浓度中位数为 145.0pg/ml，GT 为 5.1pg/ml。两个 BDG 检测方法在制造商的临界值均呈阳性结果预测了 89.5%-98.3%的确诊或可能 IFD，但两个检测方法的灵敏度均有限：FA 识别出 60.7%的 IFD（临界值：80pg/ml）。将 GT 临界值从 11.0 降低至 4.1pg/ml 将 IFD 的检出率从 35.5%提高到 54.8%。