Background: A novel high-sensitivity HBsAg quantification assay, Lumipulse HBsAg-HQ, was developed. However, its performance in practical application has not yet been adequately investigated.
Objectives: The aim of the study was to evaluate the agreement of serum HBsAg by Lumipulse HBsAg-HQ (HBsAg-HQ) with HBsAg by Architect HBsAg-QT (HBsAg-QT) and comparatively investigate the efficacy of serum HBsAg-HQ and HBsAg-QT in predicting the liver tissue pathological states of chronic hepatitis B (CHB) patients.
Material and methods: A total of 147 HBeAg-positive and 128 HBeAg-negative patients were enrolled. HBsAg-HQ and HBsAg-QT were measured using CLEIA Lumipulse G1200 and CMIA Abbott Architect I2000 automatic analyzer, respectively. The Scheuer standard was used for the pathological diagnosis of liver tissue samples.
Results: In both HBeAg-positive and HBeAg-negative patients, HBsAg-HQ was significantly positively correlated with HBsAg-QT (r = 0.913 and r = 0.959, respectively), the overall disagreement rates between HBsAg-HQ and HBsAg-QT were 2.72% (4/147) and 4.69% (6/128), respectively. In HBeAg-positive patients, the area under the ROC curve (AUC) of HBsAg-HQ and HBsAg-QT for predicting the grade ≥G3 (0.686 and 0.684, respectively) and stage ≥S4 (0.739 and 0.745, respectively) were the greatest compared with other pathological states; the optimal cutoffs of HBsAg-HQ and HBsAg-QT for predicting the grade ≥G3 were <2.244 × 107 mIU/mL and <3.589 × 107 mIU/mL, and those for predicting the stage ≥S4 were 7.328 × 106 mIU/mL and <6.194 × 106 mIU/mL, respectively.
Conclusions: HBsAg-HQ is highly correlated and in agreement with HBsAg-QT in both HBeAg-positive and HBeAg-negative patients; HBsAg-HQ and HBsAg-QT are very valuable in predicting the grade ≥G3 and stage ≥S4 in HBeAg-positive patients.
Keywords: Lumipulse HBsAg-HQ; hepatitis B surface antigen; noninvasive diagnosis; pathology; performance evaluation.