快速乳胶散射免疫比浊法检测尿RBP的方法学评价

Evaluation for Examination Methodology of Urinary Retinol Binding Protein by Latex Immunonephelometry

目的对快速乳胶散射免疫比浊法检测尿视黄醇结合蛋白（retinol binding protein，RBP）进行方法学评价。方法根据美国临床实验室标准化委员会（CLSI）中相关文件规定，对本研究方法进行精密度、线性范围、准确度、灵敏度和特异度评价。结果通过本方法检测尿RBP，最低检测限为0．0378mg／L；重复性精密度为1．121％，中间精密度为5．536％，再现性精密度为6．657％；线性范围在0～10mg／L内；回收率分别为98．67％和105．00％；当Tbil〈100mg／L时，Hb〈10mg／L时，尿Tbil和Hb对RBP的检测不存在干扰；与自动生化分析仪上采用尿RBP比对试剂盒检测结果进行相关性分析，r2=0．9740，相关度较好，且两种方法对40份临床标本检测的阳性率的差异无统计学意义（x2=0．952，P=0．329）。结论本研究通过快速乳胶散射免疫比浊法检测尿RBP，具有高灵敏度、高精密度、高准确度、抗干扰强等优点，适合在临床诊断中对尿RBP进行即时检测（point—of-care testing，POCT）。

Objective To evaluate the detection methodology of urinary retinol binding protein（RBP） by latex immune-nephelometry. Methods Tyhe Precision, linear range, accuracy, sensitivity, and specificity of the examination methodology that is currently used were evaluated according to the standard protocol of National Committee for Clinical Laboratory Standards （CLSI） documents. Results The lowest detection limit in this methodology was 0.037 8 mg/L and the linear range was 0-10 mg/L. Repeatability precision was 1.121%, inter-assay precision was 5.536% and reproducibility precision was 6.657%. The average recovery rate was 101.83% and there was no interference to RBP detection under the existence of 〈100 mg/L total bilirubin or 〈10 mg/L hemoglobin. There was a positive correlation between the present methodology and the control reagent of urinary RBP detection （r2 =0.974 0）, which was based on the platform of automatic biochemical analyzer, and there was no significance comparing with the results of urinary RBP of 40 clinical samples using these two methodology. Conclusion The present method of urinary RBP detection, with high sensitivity, precision, accuracy and strong anti-interference, is suitable for clinical laboratory point-of-care testing （POCT）.