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雅培全自动生化分析仪检测系统性能验证 被引量:1

Verification of performance of ARCHITCT automatic Biochemistry Analyzer
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摘要 目的评价雅培cil6200全自动生化分析仪的分析性能。方法按照美国临床实验室标准化协会CLSI公布的文件标准(EP5-A2,EP9-A2,EP10-A2,EP6-A2),对雅培精密度、准确度、携带污染率、线性范围等4个性能进行验证。结果批内精密度、批间精密度、准确度偏倚均低于1/4Tea(CLIA’88),携带污染率小于0.5%,线性范围结果与厂商提供的性能指标相符。结论雅培生化分析仪在精密度、准确度、携带污染率、线形范围等4个方面性能验证合格。 Objective To demonstrate the analytical performance of ARCHITCT Automatic Biochemistry Analyzer. Methods The precision,accuracy,carried contamination and linearity were validated according to Clinical and Laboratory Standards Institute(CLSI)documents(EP5-A2,EP9-A2,EP10 A2,EP6-A2). Results The within and be tween-batch precisions and accuracy evaluation experiments were all less than 1/4 Tea(CLIA'88). The carried contamination percentage of each item was under 0.5%. The linearity was in line with manufacturer's standards. Conclusion The main performance of precision, accuracy,carried contamination and linearity of ARCHITCT Automatic Biochemistry Analyzer was eligible.
作者 王晓娜
出处 《检验医学与临床》 CAS 2013年第A02期33-35,共3页 Laboratory Medicine and Clinic
关键词 全自动生化分析仪 精密度 准确度 性能验证 automatic c.hemistry analyzer precision accuracy verification
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