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罗氏cobas 6000 e601全自动电化学发光免疫分析仪性能验证 被引量:3
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作者 冯磊 徐文波 +4 位作者 张大莲 张兴锋 代艳娟 毛星星 罗曼玲 《医疗装备》 2014年第12期8-9,共2页
目的:罗氏cobas 6000 e601全自动电化学发光免疫分析仪进行仪器性能验证。方法:依照罗氏公司提供的全自动免疫分析仪性能验证程序,对试剂仓温度准确性及波动、孵育盘温度准确性及波动、测量池温度准确性及波动、加样系统准确性与重复性... 目的:罗氏cobas 6000 e601全自动电化学发光免疫分析仪进行仪器性能验证。方法:依照罗氏公司提供的全自动免疫分析仪性能验证程序,对试剂仓温度准确性及波动、孵育盘温度准确性及波动、测量池温度准确性及波动、加样系统准确性与重复性、交叉污染及灵敏度共计7项性能进行验证。结果:罗氏cobas 6000 e601全自动电化学发光免疫分析仪各项性能指标与厂商规定的分析性能基本一致,符合质量目标要求。结论:验证方案可操作性和实用性强,除可用于实验室管理机构的相关认证及认可工作,还可为仪器故障的诊断及处理提供依据。 展开更多
关键词 罗氏cobas 6000e601 全自动电化学发光免疫分析仪 性能验证
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Comparison of electrochemiluminescence and ELISA methods in the detection of blood borne pathogens in Gabon
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作者 Cyrille Bisseye Jophrette Mireille Ntsame Ndong +3 位作者 Anicet Mouity Matoumba Calixte Bengone Guy Mouelet Migolet Bolni Marius Nagalo 《Asian Pacific Journal of Tropical Biomedicine》 SCIE CAS 2017年第9期805-808,共4页
Objective: To assess the performances of Cobas 6000 e601 and EVOLIS Bio Rad in the detection of HIV, HBV and HCV in blood donors in Libreville(Gabon).Methods: A cross-sectional investigation was conducted in July 2017... Objective: To assess the performances of Cobas 6000 e601 and EVOLIS Bio Rad in the detection of HIV, HBV and HCV in blood donors in Libreville(Gabon).Methods: A cross-sectional investigation was conducted in July 2017 in a total of 2 000 blood donors recruited at the National Blood transfusion Center, Libreville Gabon.Among them, 363 donors were selected to compare the performances of COBAS 6000 e601(electro-chemiluminescence) and EVOLIS Bio Rad in detecting HIV, HBV and HCV using Cohen's kappa coefficient.Results: Both methods yielded similar results for the detection of HIV and HBs Ag. A very good agreement of 93.39% and an excellent agreement of 98.90% were obtained for the detection of HIV and Hbs Ag, with kappa values of 0.80 and 0.98, respectively. The observed agreement of 91.86% was found for the detection of HCV, which gave a fair agreement between the two methods with kappa = 0.33.Conclusions: The two evaluation methods showed a similar performance in the detection of HIV, HBV. However, given the high rate of intra and inter-genotypes recombination known for HIV and HBV, more robust techniques of detection such as polymerase chain reaction should be used to prevent post-transfusion contaminations. 展开更多
关键词 Cobas 6000 e601 EVOLIS BioRad Kappa coefficient Blood donors
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