Calero Alba Leyva, Alonso Roberto, Gadea Ignacio, Vega María Dolores Montero, García Marta Martín, Muñoz Patricia, Machado Marina, Bouza Emilio, García-Rodríguez Julio
Department of Biochemistry, Immunology and Molecular Parasitology, Universidad de Granada, Granada, Spain.
Department of Clinical Microbiology and Infectious Diseases, Hospital General Universitario Gregorio Marañón, Madrid, Spain.
Microbiol Spectr. 2022 Apr 27;10(2):e0262621. doi: 10.1128/spectrum.02626-21. Epub 2022 Mar 9.
The use of nonculture-based biomarkers such as the determination of galactomannan is sought for the diagnosis of invasive aspergillosis. To investigate the comparative yield of two tests for the detection of galactomannan in patients with or without proven or probable invasive aspergillosis. Overall, 327 samples (327 patients) were analyzed in a retrospective/prospective study performed in 3 hospitals in Madrid, comparing the determination results in serum or bronchoalveolar lavage of two techniques for galactomannan detection, namely, Platelia Aspergillus Ag (Bio-Rad) and Aspergillus galactomannan Ag Virclia Monotest (Vircell S.L.), following the manufacturer's instructions. Both techniques can automate the process, but the second technique has the advantage of individual processing and assembly of each sample without the need for the additional expense of single-dose strips in controls. In total, 288 of the 327 tests performed showed concordant results between both techniques. The agreement between both methods was к = 0.722, and the correlation between indices was ρ = 0.718. Only 39 samples showed discordant results. In those 39 cases, there were 15 patients with proven or probable invasive aspergillosis criteria. For the samples with clinical criteria as a reference, the areas under the curve of the receiver operating characteristic (ROC) curve were 0.962 for Platelia and 0.968 for VirClia. The VirClia test has been proven to be an alternative for diagnosis due to its friendlier automated format than that of the usual Platelia routine test. The VirClia test also allows individual action and, therefore, a more immediate clinical response. Invasive mycoses are increasingly present in immunosuppressed or hospitalized patients with serious illnesses, leading to high rates of morbidity and mortality. Invasive aspergillosis is an infection caused, in a percentage greater than 50%, by the genus Aspergillus. It is vitally important to make an early diagnosis that leads to the application of antifungals in the initial stage of the infection. Therefore, tools are required to help with the early diagnosis of the infection. This comparative study of two enzyme immunoassays is based on the detection of galactomannan antigen in serum and bronchoalveolar lavage samples. A new design based on chemiluminescence and presented in an automated single-dose format is compared to a conventional ELISA technique marketed for years. The results obtained from the prospective and retrospective study indicate a high correlation and degree of agreement between both techniques, as well as in their diagnostic performance.
寻求使用基于非培养的生物标志物(如半乳甘露聚糖的测定)来诊断侵袭性曲霉病。为了研究两种检测方法在已证实或可能患有侵袭性曲霉病的患者与未患该病的患者中检测半乳甘露聚糖的相对检出率。总体而言,在马德里的3家医院进行的一项回顾性/前瞻性研究中,分析了327份样本(327名患者),按照制造商的说明,比较了两种半乳甘露聚糖检测技术(即Platelia Aspergillus Ag(伯乐公司)和Aspergillus galactomannan Ag Virclia Monotest(Vircell S.L.公司))在血清或支气管肺泡灌洗中的测定结果。两种技术都可以实现自动化操作,但第二种技术的优势在于可以对每个样本进行单独处理和组装,而无需在对照中额外使用单剂量检测条。在总共进行的327次检测中,有288次两种技术的结果一致。两种方法之间的一致性系数к = 0.722,指标之间的相关性ρ = 0.718。只有39个样本结果不一致。在这39例中,有15例患者符合已证实或可能患有侵袭性曲霉病的标准。以临床标准为参考,Platelia检测的受试者操作特征(ROC)曲线下面积为0.962,VirClia检测的为0.968。已证明VirClia检测是一种诊断替代方法,因为其自动化形式比常规的Platelia常规检测更简便。VirClia检测还允许单独操作,因此能带来更即时的临床反应。侵袭性真菌病在免疫抑制或患有严重疾病的住院患者中越来越常见,导致高发病率和死亡率。侵袭性曲霉病在超过50%的病例中是由曲霉属引起的感染。早期诊断并在感染初期应用抗真菌药物至关重要。因此,需要有助于感染早期诊断的工具。这项对两种酶免疫测定法的比较研究基于血清和支气管肺泡灌洗样本中半乳甘露聚糖抗原的检测。将一种基于化学发光且以自动化单剂量形式呈现的新设计与一种已销售多年的传统酶联免疫吸附测定(ELISA)技术进行比较。前瞻性和回顾性研究获得的结果表明,两种技术之间以及它们的诊断性能之间具有高度相关性和一致性。