干式时间分辨荧光免疫层析法检测血清抗链球菌溶血素“O”的方法学性能验证

Validation of Dry Time-Resolved Fluorescence Immunochromatography for Detection of Serum Anti Streptolysin“O”

目的验证时间分辨荧光免疫层析法抗链球菌溶血素“O”(ASO)检测试剂的方法学性能。方法参照CLSI对上海捷门生物技术有限公司生产的干式时间分辨荧光分析仪(FIT-1000)ASO荧光免疫层析法检测的精密度、正确度、线性及参考范围进行验证。并以贝克曼IMMAGE800免疫散射速率法作为参考系统,对临床标本进行比对实验。结果正确度试验,检测ASO浓度分别为83.2,136和269 IU/ml的校准品,相对偏倚分别为-1.03%,-0.99%和-2.70%。检测低、高两个浓度血清标本的ASO精密度,CV分别为8.32%,6.39%。ASO浓度范围46.37~868.13 IU/ml时,线性方程为Y=0.9588X-3.889(r2=0.9985)。临床标本(n=61)比对实验,Deming回归方程Y=1.256X-6.51,r=0.9506。性能评价项目结果均达到厂商声明标准。结论应用干式时间分辨荧光分析仪(FIT-1000)及配套试剂检测ASO,其正确性、重复性良好,可满足临床尤其是基层医疗单位的要求。

Objective To verify the methodological performance of anti streptolysin“O”(ASO)detection reagent by timeresolved fluorescence immunochromatography CTRFIC.Methods According to CLSI,the precision,accuracy,linearity and reference range of ASO fluorescence immunochromatography(FIT-1000)produced by Shanghai Jiemen Biotechnology Co.Ltd were verified.Beckman IMMAGE800 was used as the reference system to compare the clinical samples.Results In the accuracy test,the relative bias was-1.03%,-0.99%and-2.70%,when the ASO concentration was 83.2,136 and 269 IU/ml,respectively.The precision of ASO was 8.32%and 6.39%respectively.When the concentration of ASO ranged from 46.37 to 868.13 IU/ml,the linear equation was Y=0.9588X-3.889(r^2=0.9985).The Deming regression equation Y=1.256X-6.51,r=0.9506.The results of performance evaluation items all meet the manufacturer’s declaration standard.Conclusion The accuracy and repeatability of dry TRFIC analyzer(FIT-1000)and related reagents for ASO detection are good,which can meet the requirements of clinical,especially primary medical units.