AS-1250M全自动生化分析仪的应用性能验证  

The Analysis Performance Evaluation of AS-1250M Automatic Biochemical Analyzer

作　　者：黄仕云 刘静 曾绮婷 黄婷 聂湘辉 HUANG Shi-yun;LIU Jing;ZENG Qi-ting;HUANG Ting;NIE Xiang-hui(Laboratory Department of Heyuan Central Blood Station,Guangdong Heyuan 517000)

机构地区：[1]河源市中心血站检验科,广东河源517000

出　　处：《中国医疗器械信息》2025年第2期47-49,59,共4页China Medical Device Information

摘　　要：目的:对本站新购置的AS-1250M全自动生化分析仪进行应用性能验证,以保障其检测结果的准确性和可靠性。方法:以谷氨酸氨基转移酶(ALT)项目为例,评价AS-1250M全自动生化分析仪的应用性能是否符合预期要求。结果:新(AS-1250M)、旧(BS-400)设备同时检测40份ALT标本,两者检测结果间差异无统计学意义(Z=0.329,P>0.05),各标本的相对偏倚均<±6%。中、低两个浓度ALT标本批内不精密度CV值分别为1.17%和1.80%,批间不精密度CV值分别为1.83%和1.86%。在2.68~602.44U/L范围表现出良好的线性关系。连续20份无偿献血者ALT标本检测结果显示,正常值参考范围通过验证。新设备携带污染率为0.31%。结论:新购置的AS-1250M全自动生化分析仪的各应用性能评价指标均符合质量标准。Objective:Analyse the automatic biochemical analyzer performance experiment evaluation,to ensure the accuracy and reliability of its results.Methods:Taking glutamate aminotransferase(ALT)as project,AS-1250M automatic biochemical analyzer were evaluated.Results:The new(AS-1250M)and old(BS-400)devices simultaneously detected 40 ALT specimens,and there was no statistically significant difference between the two detection results(Z=0.329,P>0.05).The relative bias of each specimen was<±6%.The intra batch imprecision CV values of ALT samples with medium and low concentrations were 1.17%and 1.80%,respectively,while the inter batch imprecision CV values were 1.83%and 1.86%,respectively.It shows a good linear relationship in the range of 2.68-602.44U/L.The ALT test results of 20 consecutive unpaid blood donors showed that the normal reference range was validated.The contamination rate of the new equipment was 0.31%.Conclusion:The performance evaluation indicators of the newly purchased AS-1250M fully automatic biochemical analyzer meet the quality standards.

关 键 词：全自动生化分析仪 应用性能评价 正确度 精密度 可报告线性范围 正常值参考范围 携带污染 

分 类 号：R446.1[医药卫生—诊断学]