3种血红蛋白快速检测仪检测结果可靠性分析

目的探讨不同血红蛋白快速检测仪检测结果的可接受性,为街头无偿献血初筛检测提供准确、可比的检验结果。方法随机选取60份街头采集的献血者血样,分别采用3种血红蛋白快速检测仪及血细胞分析仪检测血红蛋白含量,与参加卫生部室间质评并可溯源的血细胞分析仪(Sysmex-kx-21N)比较,建立回归方程,以1/2(CLIA'88)允许误差为标准判断偏倚是否可接受,并同时比较几种血红蛋白快速检测仪的精密度、平均检测时间。结果 3种血红蛋白快速检测仪检测结果与Sysmex-kx-21N全自动血细胞分析仪检测血红蛋白结果均有差异(p<0.05),HemoCue Hb 201+的偏倚(SE%)为1.6%,属于可接受的范围,用回归方程可以矫正;但Hemo Scan-A和Mission Hb的偏倚均大于CLIA'88允许范围3.5%,属于不可接受范围,该类仪器应重新调试或者停用;精密度最好的是HemoCue Hb 201+,最差的是Hemo Scan-A;测试时间最快的是Hemo Scan-A,最慢的是HemoCue Hb 201+。结论基于本研究的实验数据,得出HemoCue Hb201+快速检测仪检测结果具有可接受性,适合街头献血者Hb含量测定。

RELIABILITY ANALYSIS OF THE RESULTS IN 3 HEMOGLOBIN FAST DETECTORS

Objective Discuss the acceptability of test resuihs in different hemoglobin fast detectors to provide accurate and comparable test results for screening test of street free blood donation. Methods Using 3 hemoglobin fast detectors and blood cell analyzers to detect hemoglobin for 60 blood donors randomly selected at street collect station and compared with the results from the automatic blood cell analyzer（ Sysmex- kx- 21N） which is participated and traceable in the EQA of the Ministry of Health made regression equation. To judge whether the bias was acceptable by 1/2 （CLIA＇88） tolerrance, and made comparison of precision and average test time in different hemoglobin fast detectors. Results There was difference （p 〈 0. 05 ） in the results of hemoglobin between 3 hemoglobin fast detectors and Sysmex - kx -21N automatic blood cell analyzer. The bias of HemoCue Hb 201 ＋ （ SE% ） was 1.6%, which was within the acceptable limits and could be corrected by regression equation. But the bias of Hemo Scan - A and Mission Hb were larger than the 3.5 % limits allowed in CLIA＇88,which were without the acceptable limits, and the instruments should be recommissioning or stopped use. The best percision was HemoCue Hb 201 ＋ ,and the worst was Hemo Scan -A. The fastest test time was Hemo Scan -A, and the slowest was HemoCue Hb 201 ＋. Conclusion Based on the experimental data in this paper, the result from HemoCue Hb 201 ＋ fast detector is acceptable, and it is suitable to mensurate hemoglobin of blood donors at street.