Laboratoire de Parasitologie-Mycologie, Département des Agents Infectieux, Institut de Biologie et de Pathologie, CHU Grenoble Alpes, Grenoble, France.
Univ. Grenoble Alpes, CNRS, CHU Grenoble Alpes, Grenoble INP, TIMC, Grenoble, France.
Front Cell Infect Microbiol. 2021 Jul 16;11:669237. doi: 10.3389/fcimb.2021.669237. eCollection 2021.
To evaluate the analytical and clinical performance of a prototype of a VIDAS Galactomannan (GM) unitary test (bioMérieux, Marcy l'Etoile, France) and compare to that of the Platelia™ Ag assay (Bio-Rad, CA, USA).
Repeatability, reproducibility, and freeze-thaw stability of VIDASGM were evaluated. Sera from patients at risk of IA were concurrently tested with both the VIDASGM and Platelia™ Ag assays. Correlations between the two assays were assessed by Passing Bablok (PB) regression and performance by ROC analysis.
The correlations between the VIDASGM indexes after one and two cycles of freezing/thawing were r=1.00 and r=0.989, respectively. The coefficients of variation for negative, low-positive, and positive sera were 13%, 6%, and 5% for repeatability and 14.4%, 7.2%, and 5.5% for reproducibility. Overall, 126 sera were tested with both assays (44 fresh and 82 frozen). The correlation between VIDASGM and Platelia™ Ag was r=0.798. The areas under the curve of the ROC analyses were 0.892 and 0.894, for VIDASGM and Platelia™ Ag, respectively.
This new VIDASGM prototype assay showed adequate analytical and clinical performance and a good correlation with that of Platelia™ Ag with 126 sera, although these results need to be confirmed in a larger prospective and multicentric study. As for the other VIDAS assays, VIDASGM is a single-sample automated test using a solid reagent strip and receptacle. It is easy to use and suitable for rapid on-demand test results.
评估一款 Vidas 半乳甘露聚糖（GM）单元检测（法国马西-勒泰利埃的生物梅里埃）原型的分析和临床性能，并与 Platelia™ Ag 检测（美国加利福尼亚州的伯乐）进行比较。
评估 VidasGM 的重复性、再现性和冻融稳定性。同时使用 VidasGM 和 Platelia™ Ag 检测对有侵袭性曲霉菌病（IA）风险的患者的血清进行检测。通过 Passing Bablok（PB）回归评估两种检测方法之间的相关性，并通过 ROC 分析评估性能。
冻融一个和两个循环后，VIDASGM 指数之间的相关性分别为 r=1.00 和 r=0.989。阴性、低阳性和阳性血清的重复性变异系数分别为 13%、6%和 5%，再现性变异系数分别为 14.4%、7.2%和 5.5%。总体上，两种检测方法共检测了 126 份血清（44 份新鲜和 82 份冷冻）。VIDASGM 与 Platelia™ Ag 的相关性为 r=0.798。ROC 分析的曲线下面积分别为 0.892 和 0.894，用于 VidasGM 和 Platelia™ Ag。
该新型 VidasGM 原型检测方法在分析和临床性能方面表现良好，与 Platelia™ Ag 的相关性较好，尽管这些结果需要在更大的前瞻性和多中心研究中得到确认。与其他 Vidas 检测方法一样，VIDASGM 是一种使用固相试剂条和容器的单个样本自动化检测方法。它易于使用，适用于快速按需检测结果。
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