Fuster Oscar, Andino Belinda, Pardo Amparo, Laiz Begoña
Hematology Unit, Department of Clinical Chemistry, Hospital Universitari i Politècnic La Fe, Valencia, Spain.
J Clin Lab Anal. 2018 Feb;32(2). doi: 10.1002/jcla.22240. Epub 2017 Apr 26.
Accurate evaluation of hematology analyzers is recommended before these devices can be broadly introduced for the routine testing of continuous ambulatory peritoneal dialysis (CAPD), ascitic, and pleural fluids.
We evaluated the performance of Mindray BC-6800 for white blood cell (WBC) and differential cell count in 50 CAPD, 60 ascitic and 40 pleural compared with manual microscopy. Within-run precision, limit of blank (LoB), limit of detection (LoD), limit of quantitation (LoQ), and carryover were assessed.
The Passing-Bablok regression in all fluids showed the following equations: y =1.05x+3.31 (95%CI slope 0.95 to 1.12; intercept -0.25 to 5.52); y =0.85x+15.63 (95%CI slope 0.72 to 1.05; intercept -24.18 to 84.47); and y =1.21x+13.37 (95%CI slope 1.03 to 1.35; intercept 4.00 to 32.47) with bias 78 cells/μL. The AUC for clinical PMN cut-off was 0.88 (95%CI: 0.77 to 0.98). In ascitic, pleural, and CAPD fluids the AUC for clinical PMN cut-off were 0.88 (95%CI: 0.63 to 1.00), 0.83 (95%CI: 0.68 to 0.99), and 1.00 (95%CI: 1.00 to 1.00) respectively. CV ranged from 3%-34%. LoB of 3 cell/μL was verified. LoD and LoQ reported the same result (8 cells/μL). Carry over never exceeded 0.05%.
The effectiveness of BC-6800 to categorize cells from different body fluids was not compromised by the slight positive bias observed. This conclusion is supported by the high AUC and agreement between the automated method and the reference method. The results show that BC-6800 offers rapid, accurate, and reproducible results for clinical management of CAPD, ascitic, and pleural fluids.
在将血液分析仪广泛应用于持续性非卧床腹膜透析(CAPD)液、腹水和胸水的常规检测之前,建议对其进行准确评估。
我们将迈瑞BC - 6800检测50份CAPD液、60份腹水和40份胸水的白细胞(WBC)及细胞分类计数结果与手工显微镜检查结果进行比较,评估其批内精密度、空白限(LoB)、检测限(LoD)、定量限(LoQ)和携带污染率。
所有体液的Passing - Bablok回归显示以下方程:y = 1.05x + 3.31(95%CI斜率0.95至1.12;截距 - 0.25至5.52);y = 0.85x + 15.63(95%CI斜率0.72至1.05;截距 - 24.18至84.47);以及y = 1.21x + 13.37(95%CI斜率1.03至1.35;截距4.00至32.47),偏差为78个细胞/μL。临床中性粒细胞临界值的AUC为0.88(CI 95%:0.77至0.98)。在腹水、胸水和CAPD液中,临床中性粒细胞临界值的AUC分别为0.88(CI 95%:0.63至1.00)、0.83(CI 95%:0.68至0.99)和1.00(CI 95%:1.00至1.00)。变异系数(CV)范围为3% - 34%。验证了空白限为3个细胞/μL。检测限和定量限报告结果相同(8个细胞/μL)。携带污染率从未超过0.05%。
观察到的轻微正偏差并未影响BC - 6800对不同体液细胞分类的有效性。这一结论得到了高AUC以及自动化方法与参考方法之间一致性的支持。结果表明,BC - 6800为CAPD液、腹水和胸水的临床管理提供了快速、准确且可重复的结果。