Establishment of a time-resolved fluoroimmunoassay in detection of human epidermal growth factor receptor 2 / 中华核医学与分子影像杂志

ABSTRACT

Objective To set up a time-resolved fluoroimmunoassay (TRFIA) method for human epidermal growth factor receptor 2 (HER2) detection and to evaluate its performance.Methods Each well of the 96-microwell plate was coated with monoclonal antibody of HER2(H7) and another monoclonal antibody of HER2(E5) was labeled by Eu3+.The sensitivity,stability,specificity,measurement range and reference value of this method were tested.The correlation between chemiluminescence (CLIA) method and TRFIA method was analyzed.Results The sensitivity of HER2-TRFIA method was 0.214 ng/ml.The measurement range was 0.214-1 000 ng/ml.The mean within-run CV and mean between-run CV were 3.48％ and 4.13％,respectively.HER2-TRFIA method had no cross-reaction with HER1 and its reference range was 0-13.20 ng/ml.The correlation coefficient between TRFIA and CLIA was 0.997.The same batch of reagents were found to be stable for more than 6 months at 4 ℃.Conclusions HER2-TRFIA method has high sensitivity,specificity,stability and wide detecting range.It might be suitable for clinical use.