Evaluation of MycAssay™ Aspergillus for Diagnosis of Invasive Pulmonary Aspergillosis in Patients without Hematological Cancer
Evaluation of MycAssay™ Aspergillus for Diagnosis of Invasive Pulmonary Aspergillosis in Patients without Hematological Cancer
复制标题
DOI：
10.1371/journal.pone.0061545
复制
发表时间：
2013-04-19
期刊：
影响因子：
3.7
通讯作者：
Bouza, Emilio
中科院分区：
文献类型：
--
作者：
Guinea, Jesus;Padilla, Camilo;Bouza, Emilio
基于实时聚合酶链反应（PCR）的方法可以加快侵袭性曲霉病的诊断，但由于缺乏标准化而受到限制。我们评价了市售MycAssay（TM）曲霉菌试验对非血液癌症患者侵袭性曲霉菌病的诊断。我们前瞻性地收集了322例下呼吸道样本（2009年11月至2011年1月），来自175例下呼吸道感染和以下易感条件的患者：实体癌（16.8%），肝硬化（16.8%），皮质类固醇治疗（71.7%），艾滋病毒感染（15.6%）、慢性阻塞性肺疾病（COPD，52.6%）、实体器官移植（肾脏[1.2%]、心脏[3%]、肝脏[4.6%]）或无（3.5%）。当有临床指征时获得标本，并在微生物实验室进行分析。提取曲霉属DNA并通过MycXtra和MycAssay TM曲霉属扩增。曲霉属分离自65份样本（31名患者）。根据欧洲癌症研究和治疗组织和Bulpa标准（COPD患者），15例可能患有侵袭性曲霉菌病。MycAssay（TM）曲霉菌结果为阴性（n = 254）、阳性（n = 54）或不确定（n = 14）。MycAssay（TM）的灵敏度、特异性、阳性预测值、阴性预测值和诊断比值比（第一个样品/任何样品）分别为86.7/93、87.6/82.4、34.1/34.1、92.2/100和48/68.75。PCR检测阳性的样本比例（63%）与曲霉菌样本比例之间的差异。分离（75%）没有达到统计学显著性（P = 0.112）。从样品培养到观察到真菌生长的中位时间为3天，而MycAssay（TM）曲霉PCR的中位时间为4小时。MycAssay（TM）曲霉菌对诊断非血液癌症患者的侵袭性曲霉病显示出高灵敏度。当使用多个样品时，灵敏度增加。与真菌培养相比，PCR显著缩短了诊断时间。
Methods based on real-time polymerase chain reaction (PCR) can speed up the diagnosis of invasive aspergillosis but are limited by a lack of standardization. We evaluated the commercially available MycAssay (TM) Aspergillus test for the diagnosis of invasive aspergillosis in patients without hematological cancer. We prospectively collected 322 lower respiratory tract samples (November 2009-January 2011) from 175 patients with lower respiratory tract infection and the following predisposing conditions: solid cancer (16.8%), cirrhosis (16.8%), corticosteroid therapy (71.7%), HIV infection (15.6%), chronic obstructive pulmonary disease (COPD, 52.6%), solid organ transplantation (kidney [1.2%], heart [3%], liver [4.6%]), or none (3.5%). Specimens were obtained when clinically indicated and analyzed in the microbiology laboratory. Aspergillus DNA was extracted and amplified by means of MycXtra (R) and MycAssay (TM) Aspergillus. Aspergillus spp. was isolated from 65 samples (31 patients). According to the European Organization for Research and Treatment of Cancer and Bulpa's criteria (for patients with COPD), 15 had probable invasive aspergillosis. MycAssay (TM) Aspergillus results were negative (n = 254), positive (n = 54), or indeterminate (n = 14). The sensitivity, specificity, positive predictive value, negative predictive value, and diagnostic odds ratio of the MycAssay (TM) (first sample/any sample) were 86.7/93, 87.6/82.4, 34.1/34.1, 92.2/100, and 48/68.75. The differences between the proportion of samples with positive PCR determinations (63%) and the proportion of samples with Aspergillus spp. isolation (75%) did not reach statistical significance (P = 0.112). The median time from sample culture to visualization of fungal growth was 3 days, compared with similar to 4 hours for MycAssay (TM) Aspergillus PCR. MycAssay (TM) Aspergillus showed high sensitivity for the diagnosis of invasive aspergillosis in patients without hematological cancer. Sensitivity increased when multiple samples were used. Compared with fungal culture, PCR significantly reduced the time to diagnosis.