国产AFP时间分辨荧光免疫分析试剂盒的方法学评价

Methodological evaluation of homemade reagent for AFP with time-resolved fluoroimmunoassay

目的对本所研制的AFP时间分辨荧光免疫分析(TRFIA)试剂盒进行方法学评价。方法用精密度、灵敏度、稳定性及回收率等对AFP试剂盒进行方法学評价,并与进口试剂进行比较。结果国产AFP(TRFIA)试剂盒的批内和批间的CV分别为1.87%和7.95%,平均回收率为102.06%,灵敏度为0.43μg/L,同Roche公司Elecsys2010的所测值相关系数为0.7832,同Wallac公司Auto Delfia-1235的所测值相关系数为0.9739,阳性符合率为100%。结论国产AFP(TRFIA)试剂盒具有高精密度、高特异性、高稳定性,同进口试剂比较具有较高相关性,阳性符合率较好,值得临床推广应用。

Objective To evaluate the methodology for AFP with time-resolved fluoroimmunoassay （TRFIA） established by jiangsu institute of nuclear medicine. Methods precision, sensitive, stability and recovery rate of the homemade reagent were analyzed and compared with those of import reagent. Results The within-run and between-run CV of AFP （TRFIA） detecting results by homemade reagent were 1.87% and 7.95% respectively. The recovery rate was 102.06% and the sensitivity was 0.43μg/L. The coefficient of correlation to the values by Elecsys 2010 of Roche and AutoDelfia-1235 of Wallace were 0.7832 and 0.9739. Positive rate accorded with Wallace was 100%. Conclusions Homemade reagent for AFP （TRFIA） test is of high precision, sensitive and stable compared with import reagent, it can be used as a routine laboratory test.