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作 者:薛秀娟[1] 刘洋[1] 刘春华[1] 刘家琪 耿杰 张向兵[1] 闫江舟[1] 袁源[1] 任亭亭 张国龙 XUE Xiujuan;LIU Yang;LIU Chunhua;LIU Jiaqi;GENG Jie;ZHANG Xiangbing;YAN Jiangzhou;YUAN Yuan;REN Tingting;ZHANG Guolong(Henan Provincial Center for Disease Control and Prevention,Zhengzhou 450016,China)
出 处:《中国艾滋病性病》2022年第11期1302-1305,共4页Chinese Journal of Aids & STD
摘 要:目的通过分析2016-2021年河南省CD4细胞检测的能力验证数据,评价实验室检测能力。方法依据2016-2021年河南省CD4细胞检测实验室能力验证结果,汇总分析参评实验室及使用设备变化情况,比较不同年份和使用不同检测设备实验室的考评成绩,评价检测能力。结果2016-2021年,参加能力验证的实验室数量从64家增加到83家,实验室使用流式细胞仪数量从64台增至103台,设备型号从2种增加至7种。6年来能力验证参加率均为100%,合格率范围为90.63%~97.26%。不同年度和使用不同检测设备实验室的能力验证结果比较显示,差异均无统计学意义(H=3.209,P=0.668;H=9.261,P=0.159)。使用BD FACSCalibur和Bricyte E6两种设备的实验室检测不同质控品结果比较显示,BD FACSCalibur实验室检测低值质控品、中值质控品的均值范围为137.05~167.00个/μL、574.38~723.18个/μL,Bricyte E6实验室的检测均值范围为113.76~174.67个/μL、607.33~747.07个/μL,部分检测值差异有统计学意义(P<0.05)。结论连续的CD4细胞检测能力验证活动显示近年参评实验室合格率较高,由于检测设备的限制,仍需进一步改进措施,形成更加客观的评价体系。Objective To analyze the CD4 proficiency testing data from 2016 to 2021 and evaluate the detection capability of the laboratories.Methods Based on the results of CD4 proficiency test results in the province from 2016 to2021,the laboratories and equipment changes and testing capabilities were analyzed.The quality assessment results of different years and laboratories using different equipment were compared.Results From 2016 to 2021,the number of participating laboratories has increased from 64 to 83,equipment increased from 64 to 103,and instrument types increased from 2 to 7.The laboratory participation rate in the past six years was 100%,and the pass rate ranged from 90.63%to97.26%.There was no significant difference between different years and laboratories using different equipment(H=3.209,P=0.668,H=9.261,P=0.159).BD FACSCalibur laboratory detected the mean value range of low-value quality control material and median value quality control material was 137.05-167.00 cells/μL,574.38-723.18 cells/μL,and the average detection range of the Bricyte E6 laboratory was 113.76-174.67 cells/μL,607.33-747.07 cells/μL.Two quality control products detected by the laboratories using the BD FACSCalibur and Bricyte E6 devices showed that some of the detected values had statistically significant differences(P<0.05).Conclusions The continuing CD4 cell proficiency testing activities showed that the qualified rate of laboratories was relatively high in recent years.Further improvement measures are still needed to form a more objective evaluation system due to the limitation of testing equipment.
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