Abstract: Objective To analyze the consistency of results for detection of hepatitis B virus surface antigen (HBsAg) in blood donors between electrical chemiluminescence immunoassay (ECLIA) and enzymelinked immunosorbent aasay (ELISA) and to explore the effect of ECLIA application routinely in the detection of blood donors. Methods Blood samples from blood donors were collected from December 2016 to November 2017. HBsAg was detected by ECLIA and two ELISA reagents (Reagent A and Reagent B) from different manufacturers. ECLIA were also performed for some samples which were non-reactivity in HBsAg but were reactivity in nucleic acid detection (NAT) HBV DNA. According to the 0≤S/CO<0.3, 0.3≤S/CO<0.9and S/CO≥0.9 in the ELISA, the ECLIA positive samples were grouped and counted to analyze the consistency of results between ECLIA and ELISA. ECLIA was used as a reference method to analyze the sensitivity and specificity of the two ELISA reagents. Results A total of 11 127 HBsAg were detected. The positive rates of reagent A,reagent B and ECLIA were 2.642%, 3.020, and 2.894%, respectively, the differences among them were not statistically significant (P>0.05).ECLIA showed excellent consistency with the two ELISA reagents (К_{reagent A}=0.927, К_{reagent B}=0.900). With ECLIA as the reference method, in the non-reactive samples in the ELISA detection, the ECLIA positive rate of group in “0.3≤S/CO<0.9” was0.35% higher than that of group in “0≤S/CO<0.3”0.11% (P<0.05). The sensitivity of reagent A was 88.82% lower than that of reagent B 92.24%, the specificity of reagent A was 99.93% slightly higher than 99.64% of reagent B. 16 cases were positive in ECLIA from 78 cases of HBsAg which were non-reactive in ELISA but reactive in NAT, with a positive rate of 15.5%. Conclusion The detection of HBsAg samples by twice of ELISA still has the possibility of missed detection. ECLIA can shorten the "window period" of ELISA detection, and has a high consistency with the ELISA results. The existing blood detection method can add once of ECLIA to improve blood safety.

Key words: Electrical chemiluminescence immunoassay, Blood donors, HBsAg, ELISA, Blood detection