摘要
目的验证强生公司Vitros5.1FS自动生化分析仪20项常规生化检测指标的生物参考区间。方法根据生物参考区间的验证要求,每个项目纳入参考个体20例,标本采集符合要求。经评价Vitros5.1FS自动生化分析仪的性能正常,采用配套校准品和试剂校准仪器,质控结果在控,按Vitros5.1FS自动生化分析仪作业指导书进行样本检测,验证参考个体的检测结果是否与《全国临床检验操作规程》第3版或《VITROS实验方法学手册》提供的生物参考区间一致。结果除丙氨酸氨基转移酶(ALT)、天门冬氨酸氨基转移酶(AST)、肌酐(Cr)、乳酸脱氢酶(LDH)、无机磷(Phos)、胆碱酯酶(Che)与《VITROS实验方法学手册》提供的生物参考区间一致外,其他项目与《全国临床检验操作规程》(第3版)提供的生物参考区间一致。结论不同实验室应制订不同的生物参考区间,以确保临床诊断结果的准确性。
Objective To authenticate the biological reference interval of 20 biochemistry test items on Vitros5.1FS（Johnson. co. Ltd） automatic biochemistry analyzer. Methods According to the experimental requirements ,20 cases of healthy reference indi viduals were selected in each project. Sample collection met the requirements. The test equipment was validation and reliable after the performance evaluation. The sample were detected in accordance with the standard operating procedures. The results were ob- served within the reference interval provided by ＂National Clinical Laboratory Procedures（Third Edition）＂or ＂VITROS Experimen- tal Methodology Manual＂. Results The reference interval of ALT, AST, Crea, LDH, Phos, Che accorded with reference interval provided by ＂VITROS Experimental Methodology Manual＂, and the rest was consistent with that of ＂National Clinical Laboratory Procedures（Third Edition）＂. Conclusion The each laboratory should verify the biological reference intervals in order to ensure the clinical diagnosis value of results.
出处
《重庆医学》
CAS
CSCD
北大核心
2013年第3期332-333,共2页
Chongqing medicine
关键词
参考值
实验室技术和方法
化学
临床
reference values
laboratory techniques and procedures ~ chemistry, clinical
