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Published on: June 18, 2020
Serum hepatitis B core-related antigen is an effective tool to categorize patients with HBeAg-negative chronic
Elisabetta Loggi1, Ranka Vukotic1, Fabio Conti1
1Dipartimento di Scienze Mediche e Chirurgiche, Centro di Ricerca per lo Studio delle Epatiti, Università degli Studi di Bologna, Bologna, Italy.
Insights
Hepatitis B core-related antigen (HBcrAg) serum levels accurately distinguish active chronic hepatitis B from quiescent infection. This marker aids in patient classification, offering a reliable tool for clinical management.
Area of Science:
- Hepatology
- Virology
- Clinical Diagnostics
Background:
- Distinguishing active chronic hepatitis B (CHB) from clinically quiescent infection (CIB) is challenging.
- Hepatitis B core-related antigen (HBcrAg) is a quantifiable marker with diagnostic potential.
- Current methods may not always easily differentiate between CHB and CIB states.
Purpose of the Study:
- To evaluate HBcrAg serum levels in HBeAg-negative HBV infection.
- To assess HBcrAg's ability to identify clinical profiles compared to HBsAg levels.
- To determine HBcrAg's utility in classifying patients with HBV infection.
Main Methods:
- Retrospective assessment of HBcrAg serum levels using ChemiLuminescent Enzyme Immunoassay (CLEIA).
- Analysis of data from treatment-naive, HBeAg-negative patients.
- Correlation of serological data (HBcrAg, HBsAg, HBV-DNA) with clinical profiles over a minimum 1-year follow-up.
Main Results:
- HBcrAg correlated closely with HBV-DNA (Spearman r=0.746) and weakly with HBsAg (Spearman r=0.471).
- HBcrAg levels were significantly higher in CHB patients than in CIB carriers.
- An HBcrAg cut-off of 2.5 logU/mL optimally identified CIB patients with accuracy comparable to HBsAg.
Conclusions:
- Single-point HBcrAg measurement accurately identifies CIB in HBeAg-negative HBV infection.
- HBcrAg serves as a valuable tool for patient classification and clinical outcome assessment.
- HBcrAg offers improved accuracy over HBsAg in categorizing difficult-to-classify patients.
Abstract:
The discrimination between active chronic hepatitis B (CHB) and the clinically quiescent infection (CIB) is not always easy, as a significant portion of patients falls in a "grey" zone. Hepatitis B core-related antigen (HBcrAg) is a now quantifiable serological marker with potential applications in diagnosis and therapy monitoring. The aim of the present study was to evaluate the HBcrAg serum levels in HBeAg-negative HBV infection, and its ability in identifying the clinical profile, in comparison with HBsAg serum levels. HBcrAg was retrospectively assessed on serum samples from a population of treatment-naive HBeAg-negative patients by ChemiLuminescent Enzyme Immunoassay (CLEIA). HBsAg and HBV-DNA data were collected. Serological data were associated to clinical profile, defined in the subsequent follow-up of at least 1 year. In the overall population of 160 HBeAg-negative patients, HBcrAg results weakly correlated with qHBsAg levels (Spearman r = 0.471, P < 0.0001) and correlated closely with HBV-DNA (Spearman r = 0.746, P < 0.0001). HBcrAg levels were significantly higher in 85 CHB patients relative to 75 CIB carriers. A value of 2.5 logU/mL produced the optimal cut-off to identify CIB patients, with diagnostic accuracy comparable to HBsAg levels. In long-term clinical evaluation, a single measurement of HBcrAg at the established cut-off was optimally consistent with clinical outcome. Conversely, the HBsAg cut-off performed well in the true quiescent phase and less in more difficult-to-categorize patients. In conclusion, single-point use of HBcrAg serum levels provides an accurate identification of CIB and represents a useful tool for patient classification.
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