The Lumipulse G HBsAg-Quant assay for screening and quantification of the hepatitis B surface antigen

Performance evaluation of HBsAg by Lumipulse HBsAg-HQ: The agreement with HBsAg by Architect HBsAg-QT and the effectiveness in predicting liver tissue pathological states of chronic hepatitis B patients

“…However, Yang et al reported that the S gene mutations within the "a" determinant, such as T126A, T126S, Q129H, Q129R, T140S, and G145E, did not affect the correlation and agreement observed between the serum HBsAg-HQ and HBsAg-QT and HBsAg-EII. 17 In this study, regardless of the serum HBeAg state and HBsAg levels, the difference between the serum HBsAg-HQ and HBsAg-QT levels was not significant. Further analyses of the grouping according to the HBeAg state and HBsAg levels also showed similar results.…”

“…Yang et al also found that, of the 112 tested samples, HBsAg-HQ displayed an excellent correlation with both HBsAg-QT and HBsAg-EII (r = 0.985 and r = 0.990); the Bland-Altman analyses demonstrated that, compared to HBsAg-QT and HBsAg-EII, HBsAg-HQ had an upward bias of 0.19 log 10 IU/mL with a 95% LOA of -0.01 to 0.39 log 10 mIU/mL and 0.07 log 10 IU/mL with a 95% LOA of -0.12 to 0.25 log 10 mIU/mL, respectively. 17 In this study, the serum HBsAg-HQ was significantly correlated with HBsAg-QT. The Bland-Altman analyses showed that, compared to the serum HBsAg-QT, the HBsAg-HQ had a slight bias of 0.04 log 10 mIU/mL with a 95% LOA of -0.61 to 0.69 log 10 mIU/mL; the overall disagreement rate was 3.64%.…”

“…16 Recently, Yang et al evaluated and compared the agreement of the qualitative and quantitative results of serum HBsAg-HQ with HB-sAg-QT and HBsAg-EII. 17 The results showed that of the 2,043 samples tested, 1,844 samples gave negative results for both HBsAg-HQ and HBsAg-QT, and 172 samples yielded positive results for both HBsAg-HQ and HBsAg-QT. Of the remaining 27 samples that had inconsistent HBsAg results, 3 were HBsAg-QT-positive and 24 were HBsAg--HQ-positive.…”

“…11 The original studies on this assay indicated that the detection of serum HBsAg by Lumipulse HBsAg-HQ (HBsAg-HQ) could potentially assist in diagnosing occult hepatitis B infection 12−15 and showed consistent results with the qualitative and quantitative detection of serum HBsAg by Architect HBsAg-QT (HBsAg-QT) and HB-sAg by Elecsys HBsAg II (HBsAg-E II). 16,17 However, the correlation between the serum HBsAg-HQ levels and the natural history and the liver tissue pathological states of chronic HBV infection have not yet been adequately investigated. 18…”

EASL 2017 Clinical Practice Guidelines on the management of hepatitis B virus infection

“…In rare cases, the absence of HBsAg could be related to the sensitivity of the assay used for detection. 22 Patients in this phase have normal ALT values and usually, but not always, undetectable serum HBV DNA. HBV DNA (cccDNA) can be detected frequently in the liver.…”