视黄醇结合蛋白的免疫透射比浊法方法学评价

Methodological evaluation of immune turbidimetric method for assay of retinol-binding protein

目的对测定血清视黄醇结合蛋白(RBP)的胶乳增强免疫透射比浊法进行方法学的技术性能评价,为临床实验室引进该检测方法提供依据。方法采用胶乳增强免疫透射比浊法测定血清RBP,按照NCCLS评价方案和相关文件的要求,评价该方法的精密度、准确度、线性范围和干扰因素。结果正常值和高值的批内CV%为3.3%和2.5%,批间CV%为3.8%和3.2%,日间CV%为4.9%和4.0%,总CV%为6.1%和4.9%;平均回收率为98.8%;RBP线性上限为120mg/L;血红蛋白浓度≤5g/L、胆红素浓度≤442μmol/L和三酰甘油浓度≤9.0mmol/L时对RBP测定均无显著性干扰。结论胶乳增强免疫透射比浊法的可靠性强,实用性高,具备全自动生化分析仪的临床实验室值得引进该检测方法用于常规测定。

Objective To evaluate the methodological performance of the latex enhanced immune turbidimetric method for assay of retinol--binding protein in serum, to provide the basis for the introduc- tion of the detection method for clinical laboratory. Methods Using latex enhanced immune turbidimet- tic method to detect the concentration of RBP in serum, according to evaluation programs of NCCLS and related documentation requirements, to evaluate the precision, accuracy, linear range and interference factors. Results Intra CV% of normal and high values were 3.3% and 2.5%, batch CV% 3.8% and 3.2%, between--day CV%, 4.9% and 4.0% ,t he total CV% 6.1% and 4.9% ; average recovery were 98. 8% ; RBP linear upper limit were 120mg/L; RBP detection had no significant interference when he- moglobin concentration were less than or equal to 5g / L, bilirubin less than or equal to 442umol / L and triglycerides less than or equal to 9 mmol/L. Conclusions Latex enhanced immune turbidimetric method has reliability, high availability. Clinical laboratory with automatic biochemical analyzer is worth the in- troduction of this detection method for routine determination.