在COVID-19大流行期间,重症监护病房(ICU)的许多患者受到侵袭性真菌感染的影响,包括曲霉病,导致高死亡率。诊断确诊的COVID-19相关肺曲霉病(CAPA)需要临床和放射学评估,以及支气管肺泡灌洗样本或肺活检的实验室检测。然而,这些程序和设备在资源有限的发展中国家或地区往往无法获得,包括巴西。因此,替代诊断方法,如测量气管抽吸物(TA)中的曲霉半乳甘露聚糖(GM),已经被探索用于CAPA诊断。尽管如此,对基于TA的诊断测试的有效性的研究是有限的。本研究旨在评估IMMY®Sona曲霉侧流测定(LFA)在CampoGrande两家三级医院的60名疑似CAPA的ICU患者的TA样本中进行GM检测的性能。巴西。ELISA方法(PlateliaAspergillusAG,Bio-Rad®)用于检测TA样品中的曲霉GM,作为微生物标准和参考测试。15名患者(12.4%)被鉴定为具有可能的CAPA。LFA的总体准确率为94%,测试结果证明了93.1%的一致性(科恩的卡帕为0.83)。根据我们的发现,用于TA样品中曲霉GM检测的LFA表现出优异的性能,被证明是潜在CAPA的有价值的诊断工具。在系统审查中,包括两项研究,荟萃分析显示,汇总估计值的敏感性为86%(95%CI,80%-91%),特异性为93%(95%CI,86%-97%).使用LFA鉴定曲霉的诊断比值比(DOR)为103.38(95%CI,38.03-281.03)。尽管与我们的研究相比灵敏度较低,LFA似乎是CAPA的一个有希望的诊断选择,特别是在没有接受抗真菌治疗的疑似病例中。这可以及时进行抗真菌治疗,并可以降低支气管镜检查不可用或有限的地区的死亡率。
During the COVID-19 pandemic, many patients in intensive care units (ICUs) were affected by invasive fungal infections, including aspergillosis, contributing to a high mortality rate. Diagnosing proven COVID-19-associated pulmonary aspergillosis (
CAPA) requires clinical and radiological evaluations, along with laboratory testing of bronchoalveolar lavage samples or lung biopsies. However, these procedures and equipment are often inaccessible in developing countries or regions with limited resources, including Brazil. Consequently, alternative diagnostic methods, such as measuring Aspergillus galactomannan (GM) in tracheal aspirate (TA), have been explored for
CAPA diagnosis. Nonetheless, research on the efficacy of TA-based diagnostic tests is limited. This study aimed to assess the performance of the IMMY® Sona Aspergillus lateral flow assay (LFA) for GM detection in TA samples from 60 ICU patients with suspected CAPA at two tertiary hospitals in Campo Grande, Brazil. The ELISA method (Platelia Aspergillus AG, Bio-Rad®) was used to detect Aspergillus GM in TA samples, serving as the microbiological criterion and reference test. Fifteen patients (12.4%) were identified as having possible
CAPA. The overall accuracy of LFA was 94%, and the tests demonstrated an agreement of 93.1% (Cohen\'s kappa of 0.83). Based on our findings, the LFA for Aspergillus GM detection in TA samples exhibited excellent performance, proving to be a valuable diagnostic tool for potential
CAPA. In a systematic review, two studies were included, and the meta-analysis revealed pooled estimates provided a sensitivity of 86% (95% CI, 80%-91%) and specificity of 93% (95% CI, 86%-97%). The diagnostic odds ratio (DOR) for identification of Aspergillus using LFA was 103.38 (95% CI, 38.03-281.03). Despite its lower sensitivity compared to our study, the LFA appears to be a promising diagnostic option for
CAPA, particularly in suspected cases that have not received antifungal therapy. This enables timely antifungal treatment and could reduce mortality rates in regions where bronchoscopy is unavailable or limited.