BACKGROUND Several studies have used CD157 in white blood cells with or without proaerolysin (fluorescein-labeled proaerolysin [FLAER])-based flow cytometry assays in the diagnosis of paroxysmal nocturnal hemoglobinuria (PNH). METHODS We designed a seven-color CD marker panel comprising FLAER, CD15, CD64, CD24, CD14, CD157, and CD45 to verify CD157's clinical applicability and diagnostic performance in a clinical setting. RESULTS A total of 356 samples were tested. These included 43 PNH-positive samples and 313 PNH-negative samples. PNH clones confirmed by the CD157/FLAER combination were almost identical in size to the clones detected by the CD24/CD14/FLAER combination, and the accuracy of the CD157/FLAER combination was 100% in granulocytes and 99.7% in monocytes. Substitution of FLAER with CD157 resulted in 1.9% and 3.5% false-positives in granulocytes and monocytes, respectively. The accuracy was 98.3% and 96.9% in granulocytes and monocytes, respectively. Moreover, the loss of CD157 expression in granulocytes and monocytes was commonly observed in non-PNH patients. Some monocytes in non-PNH patients had weak expression of CD14 but normal expression of FLAER. In this study, PNH clones in granulocytes were always lower than those in matched monocytes. CONCLUSIONS We performed the first prospective exploration of the clinical usefulness of FLAER and CD157 in simultaneously recognizing PNH clones in granulocytes and monocytes and verified the applicability of CD157 in substitute for both CD14 and CD24. In the conditions where FLAER is not available, substitution of FLAER with CD157 is acceptable for the identification of PNH clones under the premise of giving full attention to the potential for false-positives.

中文翻译：

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包括CD157在内的流式细胞仪诊断阵发性夜间血红蛋白尿：来自现实世界的数据。

背景技术几项研究已经在有或没有基于原气溶素（荧光素标记的原气溶素[FLAER]）的流式细胞术检测中使用CD157来诊断阵发性夜间血红蛋白尿（PNH）。方法我们设计了一种七色CD标记板，包括FLAER，CD15，CD64，CD24，CD14，CD157和CD45，以验证CD157在临床环境中的临床适用性和诊断性能。结果总共测试了356个样品。其中包括43个PNH阳性样品和313个PNH阴性样品。通过CD157 / FLAER组合确认的PNH克隆的大小几乎与通过CD24 / CD14 / FLAER组合检测到的克隆大小相同，CD157 / FLAER组合的准确性在粒细胞中为100％，在单核细胞中为99.7％。用CD157替代FLAER导致1.9％和3。粒细胞和单核细胞分别有5％的假阳性。粒细胞和单核细胞的准确度分别为98.3％和96.9％。而且，在非PNH患者中通常观察到粒细胞和单核细胞中CD157表达的丧失。非PNH患者中的一些单核细胞CD14弱表达，但FLAER正常表达。在这项研究中，粒细胞中的PNH克隆始终低于匹配的单核细胞中的PNH克隆。结论我们进行了FLAER和CD157在同时识别粒细胞和单核细胞中PNH克隆的临床实用性方面的首次前瞻性探索，并验证了CD157替代CD14和CD24的适用性。在没有FLAER的情况下，