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

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.