Advances in Clinical and Experimental Medicine
2018, vol. 27, nr 8, August, p. 1045–1054
Publication type: original article
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
1 Shanghai Public Health Clinical Center, Fudan University, Shanghai, China
2 Fujirebio Shanghai Representative Office, Shanghai, China
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.
Conclusion. 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.
hepatitis B surface antigen, performance evaluation, Lumipulse HBsAg-HQ, pathology, noninvasive diagnosis
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