Department of Laboratory Medicine, University of Ulsan College of Medicine and Asan Medical Center, Seoul, Korea.
Int J Lab Hematol. 2018 Jun;40(3):258-267. doi: 10.1111/ijlh.12774. Epub 2018 Jan 4.
We developed and validated reflex testing rules for the microscopic examination (ME) of body fluids (BFs) on the Sysmex XN-550 (Sysmex Corporation) instrument.
We assessed the detection limits, precision, linearity, and carryover. To develop the reflex testing rules (derivation arm), we tested 515 samples and then validated the rules using another 507 samples (validation arm).
All analytical performances were acceptable, and the carryover was negligible. There was agreement between the automated count and ME of red blood cells (r = .98) and total nucleated cells (TNCs) (r = .98), as well as the differential counts of neutrophils (r = .90) and lymphocytes (r = .84). We developed reflex testing rules: TNCs <10/μL, cell 2/cell 1 ratio ≤0.7, HF-BF cells >7.9/100 white blood cells, LY-X ≥85 or LY-Y ≥90, and eosinophils >2.5%. In the validation arm, implementation of the rules resulted in 126 rule-negative samples (24.9%) that were well correlated between the 2 methods. We propose a new workflow for BF cell analysis based on automated counting.
The Sysmex XN-550 can be a suitable alternative to ME for BF cell analysis, especially for screening samples and subsequent automatic reporting under the rational use of laboratory-specific rules.
我们开发并验证了 Sysmex XN-550 仪器上体液(BFs)的显微镜检查(ME)的反射测试规则。
我们评估了检测限、精密度、线性和携带污染。为了开发反射测试规则(推导臂),我们测试了 515 个样本,然后使用另外 507 个样本对规则进行了验证(验证臂)。
所有分析性能均合格,携带污染可忽略不计。自动计数和 ME 的红细胞(r =.98)和总核细胞(TNC)(r =.98)以及中性粒细胞(r =.90)和淋巴细胞(r =.84)的差异计数之间存在一致性。我们开发了反射测试规则:TNCs <10/μL、细胞 2/细胞 1 比值≤0.7、HF-BF 细胞>7.9/100 白细胞、LY-X ≥85 或 LY-Y ≥90 以及嗜酸性粒细胞>2.5%。在验证臂中,实施规则导致 126 个规则阴性样本(24.9%),这两种方法之间相关性良好。我们提出了一种基于自动计数的 BF 细胞分析新工作流程。
XN-550 可以成为 BF 细胞分析的 ME 的替代方法,特别是在合理使用实验室特定规则进行筛选样本和随后的自动报告时。