Performances evaluation of Sysmex XN-9000 hematology analyzer under body fluid mode for detecting peritoneal and pleural fluids
10.7687/j.issn1003-8868.2018.06.063
- VernacularTitle:Sysmex XN-9000血液分析仪体液模式胸腹水 检测的性能评价
- Author:
Chi ZHANG
1
;
Ying LI
;
Li-Bo XIA
;
Qing GUAN
Author Information
1. 华中科技大学同济医学院附属同济医院检验科
- Keywords:
XN-9000 hematology analyzer;
peritoneal and pleural fluids;
body fluid mode;
performance assessment;
quality control
- From:
Chinese Medical Equipment Journal
2018;39(6):63-67
- CountryChina
- Language:Chinese
-
Abstract:
Object To verify and evaluate the performances of Sysmex XN-9000 hematology analyzer under body fluid mode when used for peritoneal and pleural fluids detection.Methods According to the guidance of ICSH, Sysmex XN-9000 hematology analyzer under body fluid mode had its performances verified on background counting, carryover, precision, linear range and etc of RBC-BF and TC-BF, and then was compared with microscopy on RBC-BF, TC-BF, PMN％, MN％, N％, L％, M％and E％.Results The RBC-BF and TC-BF had the background counting being 0.00, carryover being 0.00％and 0.07％ respectively, coefficients of variation (CV) of within-run precision being from 0.96％to 17.89％as well as from 2.19％to 10.33％respectively, CV of between-run precision being from 3.34％to 4.73％as well as from 8.33％to 10.75％resptctively, and the linear ranges being (0～5) ×1012/L and (0～20) ×109/L respectively. There was a high correlation between Sysmex XN-9000 hematology analyzer and microscopy when detecting RBC-BF, TC-BF, PMN％, MN％, N％, L％, M％and E％. The Spearman rank correlation coefficients (rs) were 0.977, 0.995, 0.863, 0.929, 0.926, 0.949, 0.965 and 0.816 (P<0.05), and there were statistical significances between the correlations. Bland-Altman bias analysis on the analyzer and microscopy showed that RBC-BF had the bias (4.6％) lower than that (5.6％) of TC-BF;MN％had the bias (-2.0％) lower than that (4.2％) of PMN％;L％, N％, M％and E％had the bias being-0.5％, 4.4％,-5.9％and-1.6％respectively, which were all met the requirements of the manufacturer.Conclusion Sysmex XN-9000 hematology analyzer under body fluid mode proves its performances for routine detection of peritoneal and pleural fluids.
