【摘要】 目的评估5种免疫透射比浊法试剂盒在生化分析仪上检测特定蛋白钩状效应的性能。方法应用北京九强生物技术股份有限公司(A)、四川迈克生物科技股份有限公司(B)、深圳迈瑞生物医疗电子股份有限公司(C)、宁波美康生物科技股份有限公司(D)和北京利德曼生化股份有限公司(E)5种市场占有率较高的免疫透射比浊法试剂盒,分别测定6个特定蛋白项目,在分析测量范围已知的前提下,配制一系列浓度梯度样品进行检测,比较不同厂家试剂盒钩状效应的性能。结果 5种试剂盒中,B和C测定链球菌溶血素O(ASO)、超敏C反应蛋白(hs-CRP)和β2-微球蛋白(β2-MG)3个项目抗原过量的安全范围上限较大,浓度分别在10 000IU/mL、1 000mg/L和226mg/L左右未出现钩状效应。血清胱抑素C(CysC)试剂盒中上限最大的是C和E试剂盒,均大于112mg/L。除D试剂盒外,其他厂家试剂检测视黄醇结合蛋白(RBP)的安全范围上限均在700mg/L以上。尿微量清蛋白(mALB)试剂盒抗原过量安全范围上限最大的是D,浓度达43 560mg/L左右仍未出现钩状效应。结论不同厂家免疫透射比浊法试剂盒钩状效应性能不同,实验室在使用之前应进行钩状效应性能验证,选择防范钩状效应最好的试剂盒。更多还原

【Abstract】 Objective To evaluate the performance of hook effect of five immunoturbidimetric kits for the detection of specific proteins on biochemical analyzers.Methods Five immunoturbidimetric kits with higher market share that came from Beijing BSBE(A),Sichuan maccura(B),Shenzhen Mindray(C),Ningbo Medical System(D)and Beijing Leadman(E)were used to determine six specific proteins.A series of concentration gradient samples were prepared and tested to compare the performance of hook effect from different manufactures′kits when the analytical measurement ranges were known.Results In the five kits,the upper limits of the safe range of antigen excess about ASO,hs-CRP andβ2-MG were relatively higher in B and C.No hook effect occurred at the approximate concentration of 10 000 IU/mL,1 000 mg/L and 226 mg/L respectively.The highest upper limits for CysC were C and E kits,and both were greater than 112 mg/L.The upper limits of the safety range for other manufacturers were more than 700 mg/L about RBP except for D.The maximum upper limit of mALB was D.Hook effect did not appear at the concentration of 43 560 mg/L approximately.Conclusion Different manufactures′immunoturbidimetric kits have different hook effect performance.The laboratories should verify the hook effect performance before using the kits,and select the most suitable kit to prevent hook effect.更多还原