迈瑞BC-6000Plus血细胞分析仪的临床性能评价
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摘要
目的:评价迈瑞BC-6000Plus血细胞分析仪的主要性能指标,确保临床检验的准确性。方法:依照国际血液学标准化委员会(International Council for Standardization in Haematology,ICSH)公布的评价方案以及中华人民共和国卫生行业标准WS/T 406—2012《临床血液学检验常规项目分析质量要求》对仪器的各项指标进行临床可接受性评价。根据WS/T 406—2012对仪器进行校准;本底计数采用连续检测3次稀释液的结果来评价;携带污染率采用连续检测高低值样本的差异进行评价;批内精密度采用连续检测11次新鲜全血的变异系数(coefficient of variation,CV)评价,批间精密度采用连续20次检测质控品的CV评价;不同吸样模式间比对采用自动和手动2种模式检测5个新鲜样本的偏差百分比来评价;正确度和可比性验证采用与实验室内正常参加室间质评并合格的Sysmex XE-5000血细胞分析仪比较进行评价;线性验证选用接近仪器声明检测范围的高值样本进行稀释检测评价。结果:迈瑞BC-6000Plus血细胞分析仪的校准结果、本底计数和不同吸样模式间比对结果均可满足厂家要求,精密度、正确度、线性范围良好,携带污染率小,各项性能指标均在行业标准范围内,且与Sysmex XE-5000血细胞分析仪的比对结果显示二者具有良好的可比性。结论:迈瑞BC-6000Plus血细胞分析仪临床分析性能良好,能较好地满足临床血细胞分析的需求。
Objective To evaluate the main performances of Mindray BC-6000 Plus blood cell analyzer to ensure the accuracy of clinical laboratory examinations. Methods Clinical acceptability evaluation on the analyzer performances was executed according to the proposed solution of International Council for Standardization in Haematology(ICSH) and WS/T406—2012 industrial standard of the People′s Republic of China Analytical quality specifications for routine tests in clinical hematology. The analyzer was calibrated with WS/T 406—2012 industrial standard; background counting was assessed with 3 times of continuous dilution tests; the carryover evaluation was implemented by continuous detections of the differences between high-and low-value samples; the within-run precision was evaluated by 11 times of continuous tests of the coefficient of variation(CV) of fresh whole blood, while the between-run precision was assessed by 20 times of continuous detections of the CV of the quality control materials; auto and manual sampling modes were estimated by testing the deviation percentages of 5 fresh samples; accuracy and comparability were evaluated with Sysmex XE-5000 blood cell analyzer passing external quality assessment; linear verification was performed by dilution measurement with high-value samples in the declared detection ranges. Results Mindray BC-6000 Plus blood cell analyzer showed that its parameters met the industrial standard including calibration result, background counting, sampling mode, precision, accurateness, linear range and carryover, and had a high comparability with Sysmex XE-5000 blood cell analyzer. Conclusion Mindray BC-6000 Plus blood cell analyzer proves to behave well in clinical blood cell analysis.
Objective To evaluate the main performances of Mindray BC-6000 Plus blood cell analyzer to ensure the accuracy of clinical laboratory examinations. Methods Clinical acceptability evaluation on the analyzer performances was executed according to the proposed solution of International Council for Standardization in Haematology(ICSH) and WS/T406—2012 industrial standard of the People′s Republic of China Analytical quality specifications for routine tests in clinical hematology. The analyzer was calibrated with WS/T 406—2012 industrial standard; background counting was assessed with 3 times of continuous dilution tests; the carryover evaluation was implemented by continuous detections of the differences between high-and low-value samples; the within-run precision was evaluated by 11 times of continuous tests of the coefficient of variation(CV) of fresh whole blood, while the between-run precision was assessed by 20 times of continuous detections of the CV of the quality control materials; auto and manual sampling modes were estimated by testing the deviation percentages of 5 fresh samples; accuracy and comparability were evaluated with Sysmex XE-5000 blood cell analyzer passing external quality assessment; linear verification was performed by dilution measurement with high-value samples in the declared detection ranges. Results Mindray BC-6000 Plus blood cell analyzer showed that its parameters met the industrial standard including calibration result, background counting, sampling mode, precision, accurateness, linear range and carryover, and had a high comparability with Sysmex XE-5000 blood cell analyzer. Conclusion Mindray BC-6000 Plus blood cell analyzer proves to behave well in clinical blood cell analysis.
引文
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[4]彭致平,黄明兰,赵连娣,等.迈瑞BC6800血细胞分析仪临床应用性能评价[J].国际检验医学杂志,2016,37(8):1 136-1 137.
[5]韦永琼,沈伟,刘成桂,等.迈瑞BC5390血液分析仪实验室性能验证[J].国际检验医学杂志,2016,37(8):1 046-1 048.
[6]谢楠,陆学军,赖慧英,等.迈瑞CAL8000血液分析流水线性能评价[J].中外医疗,2016,35(23):37-40.
[7]朱峰,张娜,龙平,等. Sysmex XN-1000B3全自动血液分析仪检测性能评价[J].医疗卫生装备,2015,36(8):104-106.
[8]张莉,吴炯,郭玮,等.医学检验检测系统应用前的性能评价[J].检验医学,2006,21(6):560-563.
[9]马科,张娅娟,冯博,等. Sysmex XE-5000全自动血细胞分析仪检测体液标本性能评价研究[J].医疗卫生装备,2014,35(9):90-93.
[2] CLSI. Evaluation of the linearity of quantitative measurement procedures:a statistical approach:CLSI EP06-A:2003[S].Wayne,PA,USA:CLSI,2003.
[3]田雪梅,牛莉莉,张鑫.迈瑞BC-6800血细胞分析仪的性能验证[J].新疆医学,2015,45(2):197-200.
[4]彭致平,黄明兰,赵连娣,等.迈瑞BC6800血细胞分析仪临床应用性能评价[J].国际检验医学杂志,2016,37(8):1 136-1 137.
[5]韦永琼,沈伟,刘成桂,等.迈瑞BC5390血液分析仪实验室性能验证[J].国际检验医学杂志,2016,37(8):1 046-1 048.
[6]谢楠,陆学军,赖慧英,等.迈瑞CAL8000血液分析流水线性能评价[J].中外医疗,2016,35(23):37-40.
[7]朱峰,张娜,龙平,等. Sysmex XN-1000B3全自动血液分析仪检测性能评价[J].医疗卫生装备,2015,36(8):104-106.
[8]张莉,吴炯,郭玮,等.医学检验检测系统应用前的性能评价[J].检验医学,2006,21(6):560-563.
[9]马科,张娅娟,冯博,等. Sysmex XE-5000全自动血细胞分析仪检测体液标本性能评价研究[J].医疗卫生装备,2014,35(9):90-93.