PDF(Pubmed)
Abstract：
BACKGROUND: Galactomannan (GM) testing using Platelia Aspergillus enzyme immunoassay (Platelia AGM) from bronchoalveolar lavage fluid (BALF) aids in early diagnosis of invasive pulmonary aspergillosis (IPA). Globally, only a minority of laboratories have the capability to perform on-site GM testing, necessitating accessible and affordable alternatives. Hence, we conducted a comparative evaluation of the new clarus Aspergillus GM enzyme immunoassay prototype (clarus AGM prototype) with Platelia AGM using BALF samples.
METHODS: This is a single-center, prospective, cross-sectional study, where Platelia AGM testing was routinely performed followed by clarus AGM prototype testing in those with true positive or true negative AGM test results according to the 2020 EORTC/MSG and the 2024 FUNDICU consensus definitions. Descriptive statistics, ROC curve analysis, and Spearman\'s correlation analysis were used to evaluate analytical performance of the clarus AGM prototype assay.
RESULTS: This study enrolled 259 adult patients, of which 53 (20%) were classified as probable IPA, while 206 did not fulfill IPA-criteria. Spearman\'s correlation analysis revealed a strong correlation between the two assays (rho = 0.727, p < 0.001). The clarus AGM prototype had a sensitivity of 96% (51/53) and a specificity of 74% (153/206) for differentiating probable versus no IPA when using the manufacturer recommended cut-off. ROC curve analysis showed an AUC of 0.936 (95% CI 0.901-0.971) for the clarus AGM prototype, while the Platelia AGM yielded an AUC of 0.918 (95% CI 0.876-0.959).
CONCLUSIONS: Clarus AGM prototype demonstrated a strong correlation and promising test performance, comparable to Platelia AGM, rendering it a viable alternative in patients at risk of IPA.
METHODS: This is a single-center, prospective, cross-sectional study, where Platelia AGM testing was routinely performed followed by clarus AGM prototype testing in those with true positive or true negative AGM test results according to the 2020 EORTC/MSG and the 2024 FUNDICU consensus definitions. Descriptive statistics, ROC curve analysis, and Spearman\'s correlation analysis were used to evaluate analytical performance of the clarus AGM prototype assay.
RESULTS: This study enrolled 259 adult patients, of which 53 (20%) were classified as probable IPA, while 206 did not fulfill IPA-criteria. Spearman\'s correlation analysis revealed a strong correlation between the two assays (rho = 0.727, p < 0.001). The clarus AGM prototype had a sensitivity of 96% (51/53) and a specificity of 74% (153/206) for differentiating probable versus no IPA when using the manufacturer recommended cut-off. ROC curve analysis showed an AUC of 0.936 (95% CI 0.901-0.971) for the clarus AGM prototype, while the Platelia AGM yielded an AUC of 0.918 (95% CI 0.876-0.959).
CONCLUSIONS: Clarus AGM prototype demonstrated a strong correlation and promising test performance, comparable to Platelia AGM, rendering it a viable alternative in patients at risk of IPA.
摘要：
背景：使用来自支气管肺泡灌洗液（BALF）的Platelia曲霉酶免疫测定（PlateliaAGM）进行半乳甘露聚糖（GM）检测有助于早期诊断侵袭性肺曲霉病（IPA）。全球范围内,只有少数实验室有能力进行现场转基因测试，需要可获得和负担得起的替代品。因此，我们使用BALF样本对新型Clarus曲霉GM酶免疫测定原型(ClarusAGM原型)和PlateliaAGM进行了比较评价.
方法：这是一个单中心，prospective,横断面研究，根据2020EORTC/MSG和2024FUNDICU共识定义，常规进行PlateliaAGM测试，然后对AGM测试结果为真阳性或真阴性的患者进行ClarusAGM原型测试。描述性统计，ROC曲线分析,和Spearman相关性分析用于评估ClarusAGM原型测定法的分析性能。
结果：这项研究招募了259名成年患者，其中53(20%)被归类为可能的IPA，而206不符合IPA标准。Spearman的相关性分析揭示了两种测定之间的强相关性(rho=0.727,p<0.001)。当使用制造商推荐的截止值时,ClarusAGM原型具有96%(51/53)的灵敏度和74%(153/206)的特异性,用于区分可能的与无IPA。ROC曲线分析显示，ClarusAGM原型的AUC为0.936（95％CI0.901-0.971），而PlateliaAGM的AUC为0.918（95%CI0.876-0.959）。
结论：ClarusAGM原型表现出很强的相关性和有希望的测试性能，与PlateliaAGM相比，使其成为有IPA风险的患者的可行替代方案。
方法：这是一个单中心，prospective,横断面研究，根据2020EORTC/MSG和2024FUNDICU共识定义，常规进行PlateliaAGM测试，然后对AGM测试结果为真阳性或真阴性的患者进行ClarusAGM原型测试。描述性统计，ROC曲线分析,和Spearman相关性分析用于评估ClarusAGM原型测定法的分析性能。
结果：这项研究招募了259名成年患者，其中53(20%)被归类为可能的IPA，而206不符合IPA标准。Spearman的相关性分析揭示了两种测定之间的强相关性(rho=0.727,p<0.001)。当使用制造商推荐的截止值时,ClarusAGM原型具有96%(51/53)的灵敏度和74%(153/206)的特异性,用于区分可能的与无IPA。ROC曲线分析显示，ClarusAGM原型的AUC为0.936（95％CI0.901-0.971），而PlateliaAGM的AUC为0.918（95%CI0.876-0.959）。
结论：ClarusAGM原型表现出很强的相关性和有希望的测试性能，与PlateliaAGM相比，使其成为有IPA风险的患者的可行替代方案。
