[Comparative analysis of electro-chemiluminescence immunoassay and chemiluminescent microparticle immunoassay abilities to quantitatively assess hepatitis B surface antigen].

OBJECTIVE

To perform a systematic comparative analysis of two different commercial automated systems using chemiluminescence immunoassay to quantitatively detect hepatitis B virus surface antigen (HBsAg) in patient sera.

METHODS

The Elecsys2010 electrical chemiluminescence immunoassay (ECLIA; manufactured by Roche) and the ARCHITECT il000 chemiluminescence magnetic microparticle immunoassay (CMIA; manufactured by Abbott) were used to detect HBsAg in 100 serum samples of individuals who presented at our department with suspected hepatitis infection between January and May 2012. The manufacturer's protocols were strictly followed. The categorical data was analyzed by Chi-squared test, and linear regression analysis was used to compare the results of the two assay systems.

RESULTS

The HBsAg detection results from the two different assay systems showed good correlation (r >or= 0.95), and had good correlation at a low (r = 0.966), medium (r = 0.974) and high (r = 0.984) cutoff values. However, the positive detection rate of CMIA was significantly higher than that of ECLIA(94% vs. 88%, P < 0.05). When the HBsAg content was below 0.10 IU/ml, the ECLIA detection rate and sensitivity were slightly higher than those of CMIA.

CONCLUSION

The ARCHITECT i1000 and Elecsys 2010 immunoassay systems have good correlation in quantitative detection of HBsAg, but the former may be more sensitive.