The Performance Evaluation of Sysmex-XN Automatic Hematology Analyzer in Complete Blood Count_West China Medical Journal

Authors：

 MAOZhi-gang , JINYong-mei , ZHENGQin , ZENGTing-ting , CHENYue-mei ,  SUJun

Department of Clinical Laboratory, West China Hospital, Sichuan University, Chengdu, Sichuan 610041, P. R. China;

Corresponding?author：

SUJun, Email: daisy2667@163.com

Keywords：

Sysmex-XN automatic hematology analyzer; Performance evaluation; Precision; Comparability test; Residual contamination rate

DOI：

10.7507/1002-0179.20140265

Video：

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Objective To evaluate the complete blood count performance quality of Sysmex-XN automatic hematology analyzer. Methods We investigated the precision rate, residual contamination rate, analytic linearity range, and background counting of Sysmex-XN-B3 analyzer. Results The inner and inter-group precision test showed that the inaccuracy of the analyzer was lower than the allowable standard of 1/4 (CLIA'88). The highest level of residual contamination rate was 0.12%, lower than the standard of manufacturer (≤1%). Linearity evaluation showed that the white blood cell count analytic linear range was from 0.51×10⁹/L to 393.40×10⁹/L, the red blood cell count analytic linear range was from 0.51×10¹²/L to 8.15×10¹²/L, the hemoglobin analytic linear range from 15.0 g/L to 244.5 g/L, and the platelet count analytic linear range was from 3.0×10⁹/L to 2 072.5×10⁹/L. Background counting was also lower than the standard of manufacturer. Comparison between the two different series of analyzers showed that the inaccuracy rate of Sysmex-XN-B3 was not only lower than the standard of National Center for Clinical Laboratories, but also lower than the standard of 1/2 (CLIA'88). Conclusion Sysmex-XN automatic hematology analyzer has a high performance in capability evaluation. It is an excellent tool for routine hematologic blood examination.

Citation： MAOZhi-gang, JINYong-mei, ZHENGQin, ZENGTing-ting, CHENYue-mei, SUJun. The Performance Evaluation of Sysmex-XN Automatic Hematology Analyzer in Complete Blood Count. West China Medical Journal, 2014, 29(5): 871-874. doi: 10.7507/1002-0179.20140265 Copy

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1. 龐博, 劉貴建. 血液細胞分析技術的臨床應用與研究進展[J]. 首都醫科大學學報, 2013, 34(4):550-553.
2. 梁芳, 葛亮, 張憲波. NCCLS Ep9-A2文件在不同血細胞分析儀結果比對中的應用[J]. 航空航天醫學雜志, 2011, 22(2):216-218.
3. 張莉, 吳炯, 郭瑋, 等. 醫學檢驗檢測系統應用前的性能評價[J]. 檢驗醫學, 2006, 21(6):560-563.
4. 葉應嫵, 王毓三, 中華人民共和國衛生部醫政司. 全國臨床檢驗操作規程[M]. 2版. 南京:東南大學出版社, 1997:54.
5. NCCLS. ISBN 1-56238-451-1/ISSN 0273-3099 User demonstration of performance for precision and accuracy; approved guideline. NCCLS document EP15-A[S]. Wayne, PA:NCCLS, 2001.
6. 中華人民共和國衛生部. WS/T 406-2012臨床血液學檢驗常規項目分析質量要求[S]. 2012.
7. NCCLS. ISBN 1-56238-498-8 Evaluation of the linearity of quantitative measurement procedures:a statistical approach. Approved guideline. NCCLS document EP6-A[S]. Wayne, PA:NCCLS, 2003.
8. NCCLS. ISBN 1-56238-472-4/ISSN 0273-3099 Method comparison and bias estimation using patient samples; approved guideline-second edition. NCCLS document EP9-A2[S]. Wayne, PA:NCCLS, 2002.
9. 許秀妝, 陳燕妝, 章金燦, 等. Sysmex XE-5000全自動血細胞分析儀性能評價[J]. 檢驗醫學與臨床, 2011, 8(23):2896-2898.
10. 馮仁豐. 臨床檢驗質量管理技術基礎[M]. 2版. 上海:上海科學技術文獻出版社, 2003:45-46.
11. 劉紋, 鄭炘, 劉曉敏. SYSMEX-XE-5000血細胞分析儀血小板計數性能評價分析[J]. 檢驗醫學與臨床, 2011, 8(20):2492-2494.
12. Briggs C, Longair I, Kumar P, et al. Performance evaluation of the Sysmex haematology XN modular system[J]. J Clin Pathol, 2012, 65(11):1024-1030.
13. 叢玉隆, 樂家新, 袁家穎. 實用血細胞分析技術與臨床[M]. 北京:人民軍醫出版社, 2011:14.

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West China Medical Journal

The Performance Evaluation of Sysmex-XN Automatic Hematology Analyzer in Complete Blood Count

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