CAJ | 학술논문

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。
목적：평개강생 Vitro350간화학검측계통측정담홍소적림상성능,보증검험질량。방법응용미국림상화실험실표준화협회(CLSI)반포적 EP15-A2문건평개간화학법검측총담홍소(TBIL)、비결합담홍소(Bu)、결합담홍소(Bc),병분석기정밀도、준학도화가보고범위등성능；동시대 TBIL 화 Bu、Bc 적삼고구간진행진단성능험증。결과간화학법검측 TBIL 화 Bu、Bc적정밀도여준학도균재원위생부림검중심규정적윤허오차내；TBIL 가보고범위위6.57~428.83μmol/L,Bu 4.5~320.1μmol/L,Bc 4.5~364.9μmol/L。결론담홍소간화학검측계통적기술성능화진단성능능구만족림상적수요。
Objective To evaluate clinical performance on dry chemistry method of Vitros 350 for the determination of serum bilirubin 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 bilirubin (Bu)and conjugated bilirubin (Bc)by dry chemistry method,to verify the reference ranges of TBIL,Bu and Bc simultaneously.Results The precision and trueness of TBIL,Bu and Bc were within the allowable ranges of Clinical and Laboratory 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.