Vitros 350干化学分析仪检测胆红素的临床性能评估  

Clinical performance evaluation on dry chemistry method of Vitros 350 for the determination of serum bilirubin

作　　者：余琳[1] 李飞奉[1] 高月亭[1] 林勇平[1] 范婷婷[1] 刘忠民[1] 

机构地区：[1]广州医科大学附属第一医院检验科,广东广州510120

出　　处：《国际检验医学杂志》2015年第19期2812-2813,2816,共3页International Journal of Laboratory Medicine

摘　　要：目的评价强生Vitro350干化学检测系统测定胆红素的临床性能,保证检验质量。方法应用美国临床和实验室标准化协会（CLSI）颁布的EP15-A2文件评价干化学法检测总胆红素（TBIL）、非结合胆红素（Bu）、结合胆红素（Bc）,并分析其精密度、准确度和可报告范围等性能;同时对TBIL和Bu、Bc的参考区间进行诊断性能验证。结果干化学法检测TBIL和Bu、Bc的精密度与准确度均在原卫生部临检中心规定的允许误差内;TBIL可报告范围为6.57~428.83μmol/L,Bu 4.5~320.1μmol/L,Bc 4.5~364.9μmol/L。结论胆红素干化学检测系统的技术性能和诊断性能能够满足临床的需要。Objective To evaluate clinical performance on dry chemistry method of Vitros 350 for the determination of serum biliruhin in order to ensure the quality of examination. Methods Evaluation protocols were employed to evaluate the precision, the trueness and the linearity of total bilirubin（TBIL）, unconjugated biliruhin （Bu） and conjugated bilirubin （Be） by dry chemistry method,to verify the reference ranges of TBIL,Bu and Bc simultaneously. Results The precision and trueness of TBIL,Bu and Be were wilhin the allowable ranges of Clinical and l,aboratory Ltandards Institute （CLSI）. The linear range of TBIL, Bu and Bc in our laboratory were 6.57-428.83 μmol/L,4.5-320.1 μmol/L and 4.5-364.9 μmol/L respectively. Conclusion Both technical per- formance evaluation and diagnostic performance verification of bilirubin by dry chemical detection system could meet the needs of the clinic.

关 键 词：胆红素 干化学检测系统 性能评估 

分 类 号：R446.1[医药卫生—诊断学]