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. Key words: Receptor, epidermal growth factor; Breast neoplasms; Fluoroimmunoassay
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