Abstract

Serum (1→3)-β-D-glucan (BDG), is an adjunct test in the diagnosis of invasive fungal disease (IFD). Fungitell STAT™, a facile, rapid, single patient option, executable for one or more patient specimens in approximately an hour, has been developed to address a need for rapid in-house testing. This method presents qualitative information concerning serum BDG levels, using an index value that allows the rapid categorization of patients as positive, negative, or indeterminate relative to serum BDG titer. The categorical and analytical performance of Fungitell STAT was evaluated. The categorical agreement between methods was established by testing patient samples which had been previously categorized with Fungitell. Receiver Operating Characteristic curves were used to identify cut-offs using 93 de-identified patient specimens. Subsequently, using these cutoffs, an independent group of 488 patient specimens was analyzed. Positive percent agreement (PPA) with, and without, indeterminate results was 74% and 99%, respectively. Negative percent agreement (NPA) was 91% and 98% with, and without, indeterminate results, respectively. Additionally, commercially available normal off-the-clot sera were spiked with Saccharomyces cerevisiae-derived (1→3)-β-D-glucan to produce analytical samples. Analytical reproducibility using spiked samples was excellent with 94% of the CV (coefficient of variation) values ≤10% among three independent laboratories. Good correlation with the predicate method was demonstrated with correlation coefficients of 0.90 or better with patient samples and 0.99 with spiked samples. The Fungitell STAT index assay provides a rapid and suitable method for serum BDG testing.

中文翻译：

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Fungitell STAT™（一种快速（1→3）-β-D-葡聚糖单个患者样品的体外诊断测定）的性能特征。

摘要

血清（1→3）-β-D-葡聚糖（BDG）是诊断浸润性真菌病（IFD）的辅助测试。Fungitell STAT™是一种便捷，快速，单人选件，可以在大约一个小时内完成一个或多个患者标本的开发，以满足快速内部测试的需求。该方法使用一个索引值来提供有关血清BDG水平的定性信息，该索引值允许将患者相对于血清BDG滴度的快速分类为阳性，阴性或不确定。评估了Fungitell STAT的分类和分析性能。方法之间的绝对一致性是通过测试以前用Fungitell进行分类的患者样本建立的。使用接收者操作特征曲线，使用93个未识别的患者标本来识别临界值。后来，使用这些临界值，分析了一个独立组的488个患者标本。有和没有不确定结果的肯定协议百分比（PPA）分别为74％和99％。负百分比一致性（NPA）分别为91％和98％，有和没有不确定结果。此外，将市售的常规场外血清掺入酿酒酵母衍生的（1→3）-β-D-葡聚糖产生分析样品。在三个独立实验室中，使用加标样品的分析重现性极佳，CV（变异系数）值≤94％达到94％。与谓词方法的相关性良好，患者样本的相关系数为0.90或更高，加标样本的相关系数为0.99。Fungitell STAT指数测定法为血清BDG检测提供了一种快速而合适的方法。