Background Early diagnosis and prompt initiation of specific antifungal treatment are essential for improving the prognosis of mucormycosis. We aimed to assess the performance of serum Mucorales quantitative polymerase chain reaction (qPCR) for the early diagnosis and follow-up of mucormycosis. Methods We prospectively enrolled 232 patients with suspicion of invasive mold disease, evaluated using standard imaging and mycological procedures. Thirteen additional patients with proven or probable mucormycosis were included to analyze DNA load kinetics. Serum samples were collected twice-a-week for Mucorales qPCR tests targeting the Mucorales genera Lichtheimia, Rhizomucor, and Mucor/Rhizopus. Results The sensitivity was 85.2%, specificity 89.8%, and positive and negative likelihood ratios 8.3 and 0.17, respectively in this prospective study. The first Mucorales qPCR-positive serum was observed a median of 4 days (interquartile range [IQR], 0–9) before sampling of the first mycological or histological positive specimen and a median of one day (IQR, −2 to 6) before the first imaging was performed. Negativity of Mucorales qPCR within seven days after liposomal-amphotericin B initiation was associated with an 85% lower 30-day mortality rate (adjusted hazard ratio = 0·15, 95% confidence interval [.03–.73], P = .02). Conclusions Our study argues for the inclusion of qPCR for the detection of circulating Mucorales DNA for mucormycosis diagnosis and follow-up after treatment initiation. Positive results should be added to the criteria for the consensual definitions from the European Organization for the Research and Treatment of Cancer/Mycoses Study Group Education and Research Consortium (EORTC/MSGERC), as already done for Aspergillus PCR.

中文翻译：

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血清毛霉目聚合酶链反应 (PCR) 诊断毛霉菌病的评价：MODIMUCOR 前瞻性试验

背景 早期诊断和及时启动特异性抗真菌治疗对于改善毛霉菌病的预后至关重要。我们旨在评估血清毛霉目定量聚合酶链反应 (qPCR) 在毛霉菌病早期诊断和随访中的性能。方法 我们前瞻性地招募了 232 名怀疑患有侵袭性霉菌病的患者，并使用标准影像学和真菌学程序进行了评估。另外 13 名确诊或疑似毛霉菌病患者被纳入分析 DNA 载量动力学。每周两次收集血清样本用于针对毛霉目 Lichtheimia、Rhizomucor 和 Mucor/Rhizopus 属的毛霉目 qPCR 测试。结果 本前瞻性研究的敏感性为 85.2%，特异性为 89.8%，阳性似然比和阴性似然比分别为 8.3 和 0.17。第一个毛霉菌 qPCR 阳性血清在第一个真菌学或组织学阳性标本取样前的中位数时间为 4 天（四分位数间距 [IQR]，0-9），在第一个真菌学或组织学阳性标本取样之前的中位数时间为一天（IQR，-2 至 6）进行了第一次成像。脂质体两性霉素 B 开始后 7 天内毛霉目 qPCR 的阴性与 30 天死亡率降低 85% 相关（调整后的风险比 = 0·15，95% 置信区间 [.03–.73]，P = .02 ). 结论 我们的研究主张将 qPCR 用于检测循环毛霉菌目 DNA，用于毛霉菌病的诊断和治疗开始后的随访。