Sysmex XN-L-550全自动血细胞分析仪性能验证及评价
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摘要
目的:对Sysmex XN-L-550全自动血细胞分析仪的主要性能进行验证和评价。方法:参照WS/T 406—2012《临床血液学检验常规项目分析质量要求》、WS/T 405—2012《血细胞分析参考区间要求》及美国临床和实验室标准化委员会相关文件,以靶机Sysmex XE-5000全自动血细胞分析仪为参照仪器,对Sysmex XN-L-550全自动血细胞分析仪的检测项目白细胞(WBC)、红细胞(RBC)、血红蛋白(Hb)、红细胞比容(HCT)、血小板(PLT)、红细胞平均体积(MCV)、平均红细胞血红蛋白含量(MCH)、平均红细胞血红蛋白浓度(MCHC)的本底计数、携带污染率、精密度、正确度、仪器不同吸样模式的结果可比性、实验室内的结果可比性、参考区间、线性范围进行验证。结果:该仪器的WBC、RBC、Hb、PLT本底检测结果良好;WBC、RBC、Hb、PLT携带污染率均为0.00%,符合标准要求;WBC、RBC、Hb、HCT、PLT、MCV、MCH、MCHC批内和批间精密度的变异系数均小于参考值;以Sysmex XE-5000全自动血细胞分析仪的测定均值为标准,偏倚分别为WBC 4.01%、RBC 0.10%、Hb 0.56%、HCT 1.44%、PLT 3.69%、MCV 1.31%、MCH 0.42%、MCHC-0.95%,均低于允许偏差;与Sysmex XE-5000全自动血细胞分析仪的比对结果及自动和手动吸样模式的比对结果均具有可比性;参考区间符合实验室检测人群,线性范围宽。结论:Sysmex XN-L-550全自动血细胞分析仪各项性能指标验证结果良好,可满足临床检测要求。
Objective To verify and evaluate the main performances of Sysmex XN-L-550 automatic blood cell analyzer.Methods According to WS/T 406—2012 Analytical quality specifications for routine tests in clinical hematology, WS/T 405—2012 Reference intervals for blood cell analysis and related documents of Clinical and Laboratory Standards Institute of the United States Sysmex XN-L-550 blood cell analyzer had its indexes verified including background count of WBC, RBC, Hb,HCT, PLT, MCV, MCH and MCHC, carryover, precision, accuracy, results comparability for different sampling modes and labs, reference interval as well as linear range, with Sysmex XE-5000 automatic blood cell analyzer as the reference. Results The analyzer behaved well in background count of WBC, RBC, Hb and PLT; the carryovers of WBC, RBC, Hb and PLT were all 0.00%; the coefficients of variation of within-and inter-assay of WBC, RBC, Hb, HCT, PLT, MCV, MCH and MCHC were all lower than the reference values; when compared with measure values by Sysmex XE-5000 analyzed, the biases of WBC,RBC, Hb, HCT, PLT, MCV, MCH and MCHC were 4.01%, 0.10%, 0.56%, 1.44%, 3.69%, 1.31%, 0.42% and -0.95%respectively, which were all lower than allowable deviations; the results by Sysmex XE-5000 and Sysmex XN-L-550 analyzers as well as by auto and manual sampling were all comparable; Sysmex XN-L-550 analyzer had the reference intervals and linear range meet the requirements. Conclusion Sysmex XN-L-550 automatic blood cell analyzer has good performances and can meet the clinical lab requirements. [Chinese Medical Equipment Journal,2019,40(6):48-51]
Objective To verify and evaluate the main performances of Sysmex XN-L-550 automatic blood cell analyzer.Methods According to WS/T 406—2012 Analytical quality specifications for routine tests in clinical hematology, WS/T 405—2012 Reference intervals for blood cell analysis and related documents of Clinical and Laboratory Standards Institute of the United States Sysmex XN-L-550 blood cell analyzer had its indexes verified including background count of WBC, RBC, Hb,HCT, PLT, MCV, MCH and MCHC, carryover, precision, accuracy, results comparability for different sampling modes and labs, reference interval as well as linear range, with Sysmex XE-5000 automatic blood cell analyzer as the reference. Results The analyzer behaved well in background count of WBC, RBC, Hb and PLT; the carryovers of WBC, RBC, Hb and PLT were all 0.00%; the coefficients of variation of within-and inter-assay of WBC, RBC, Hb, HCT, PLT, MCV, MCH and MCHC were all lower than the reference values; when compared with measure values by Sysmex XE-5000 analyzed, the biases of WBC,RBC, Hb, HCT, PLT, MCV, MCH and MCHC were 4.01%, 0.10%, 0.56%, 1.44%, 3.69%, 1.31%, 0.42% and -0.95%respectively, which were all lower than allowable deviations; the results by Sysmex XE-5000 and Sysmex XN-L-550 analyzers as well as by auto and manual sampling were all comparable; Sysmex XN-L-550 analyzer had the reference intervals and linear range meet the requirements. Conclusion Sysmex XN-L-550 automatic blood cell analyzer has good performances and can meet the clinical lab requirements. [Chinese Medical Equipment Journal,2019,40(6):48-51]
引文
[1]医学实验室质量和能力认可准则(ISO 15189:2012):CNAS-CL02:2012[S].北京:中国标准出版社,2012.
[2]临床血液学检验常规项目分析质量要求:WS/T 406—2012[S].北京:中国标准出版社,2012.
[3]血细胞分析参考区间:WS/T 405—2012[S].北京:中国标准出版社,2012.
[4] National Committee for Clinical Laboratory Standards. Evaluation of the linearity of quantitative measurement procedures:a statistical approach:EP6-A[S]. Wayne,PA,USA:NCCLS,2003.
[5]孔莉,王建平,童兰庭,等.不同型号Sysmex血细胞分析仪检测红细胞计数及相关参数的比较[J].医疗卫生装备,2017,38(5):95-98.
[6]张驰,李莹,夏丽波,等. Sysmex XN-9000血液分析仪体液模式胸腹水检测的性能评价[J].医疗卫生装备,2018,39(6):63-67.
[7]曾付芳,田方,项渊,等.血液筛查实验室定性检测方法的性能验证[J].世界最新医学信息文摘,2018,18(30):18-20.
[8]陈瑜,孙朝琴,程树强,等. Sysmex XN-2000全自动血细胞分析仪的性能验证[J].贵州医药,2018,42(3):355.
[2]临床血液学检验常规项目分析质量要求:WS/T 406—2012[S].北京:中国标准出版社,2012.
[3]血细胞分析参考区间:WS/T 405—2012[S].北京:中国标准出版社,2012.
[4] National Committee for Clinical Laboratory Standards. Evaluation of the linearity of quantitative measurement procedures:a statistical approach:EP6-A[S]. Wayne,PA,USA:NCCLS,2003.
[5]孔莉,王建平,童兰庭,等.不同型号Sysmex血细胞分析仪检测红细胞计数及相关参数的比较[J].医疗卫生装备,2017,38(5):95-98.
[6]张驰,李莹,夏丽波,等. Sysmex XN-9000血液分析仪体液模式胸腹水检测的性能评价[J].医疗卫生装备,2018,39(6):63-67.
[7]曾付芳,田方,项渊,等.血液筛查实验室定性检测方法的性能验证[J].世界最新医学信息文摘,2018,18(30):18-20.
[8]陈瑜,孙朝琴,程树强,等. Sysmex XN-2000全自动血细胞分析仪的性能验证[J].贵州医药,2018,42(3):355.