Diagnostic and analytical performance of the hepatitis B core related antigen immunoassay in hepatitis B patients.
Acute Disease
Adolescent
Adult
Aged
Biomarkers
/ blood
Cross Reactions
Female
Hepatitis B
/ diagnosis
Hepatitis B Antibodies
/ blood
Hepatitis B Core Antigens
/ blood
Humans
Immunoassay
Male
Middle Aged
Reagent Kits, Diagnostic
/ standards
Retrospective Studies
Sensitivity and Specificity
Young Adult
Diagnostics
Hepatitis B core related antigen
Hepatitis B virus
Sensitivity and specificity
Serological marker
Journal
Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology
ISSN: 1873-5967
Titre abrégé: J Clin Virol
Pays: Netherlands
ID NLM: 9815671
Informations de publication
Date de publication:
05 2019
05 2019
Historique:
received:
02
11
2018
revised:
24
02
2019
accepted:
03
03
2019
pubmed:
11
3
2019
medline:
21
5
2020
entrez:
11
3
2019
Statut:
ppublish
Résumé
Novel serological markers for Hepatitis B virus (HBV) infection are needed for prognosis and guidance of therapy. We evaluated the diagnostic performance of the Fujirebio Lumipulse G HBcrAg immunoassay on the Fujirebio LUMIPULSE G1200 analyzer. Analytical performance was examined using three HBeAg positive HBV samples. Diagnostic specificity was assessed using subpanels of 54 confirmed acute HAV, HCV, HEV, B19, CMV and EBV infections. Diagnostic sensitivity was investigated in well-defined HBV positive patient groups, both treated and untreated, including immunocompromised patients. The Lumipulse G HBcrAg immunoassay provided a linear measurement at a dilution between 1:100 and1:10,000. Six out of 54 samples showed non-specific reactivity in sera from acute CMV, EBV and HEV infections, of which 2 of them >3 log U/ml. The highest levels of HBcrAg were measured in HBeAg positive patients, in both treated and untreated as well as in immunocompromised patients. Untreated patients had relatively low serum HBcrAg levels in the inactive carrier phase, which increased upon progression into the HBeAg-negative hepatitis phase. Also, we showed that the applicability of HBcrAg to distinguish between patients with resolved HBV infection and false-positive reactivity to solitary anti-HBc is limited. Our study demonstrated significant differences in HBcrAg levels depending on HBeAg status, the clinical phase, as well as the treatment status. Specificity of the assay is good; only 2 out of 54 samples showed reactivity above 3 log U/ml. Before implementing the assay in clinical practice, additional research in larger patient cohorts should be carried out.
Sections du résumé
BACKGROUND
Novel serological markers for Hepatitis B virus (HBV) infection are needed for prognosis and guidance of therapy.
OBJECTIVE
We evaluated the diagnostic performance of the Fujirebio Lumipulse G HBcrAg immunoassay on the Fujirebio LUMIPULSE G1200 analyzer.
STUDY DESIGN
Analytical performance was examined using three HBeAg positive HBV samples. Diagnostic specificity was assessed using subpanels of 54 confirmed acute HAV, HCV, HEV, B19, CMV and EBV infections. Diagnostic sensitivity was investigated in well-defined HBV positive patient groups, both treated and untreated, including immunocompromised patients.
RESULTS
The Lumipulse G HBcrAg immunoassay provided a linear measurement at a dilution between 1:100 and1:10,000. Six out of 54 samples showed non-specific reactivity in sera from acute CMV, EBV and HEV infections, of which 2 of them >3 log U/ml. The highest levels of HBcrAg were measured in HBeAg positive patients, in both treated and untreated as well as in immunocompromised patients. Untreated patients had relatively low serum HBcrAg levels in the inactive carrier phase, which increased upon progression into the HBeAg-negative hepatitis phase. Also, we showed that the applicability of HBcrAg to distinguish between patients with resolved HBV infection and false-positive reactivity to solitary anti-HBc is limited.
CONCLUSIONS
Our study demonstrated significant differences in HBcrAg levels depending on HBeAg status, the clinical phase, as well as the treatment status. Specificity of the assay is good; only 2 out of 54 samples showed reactivity above 3 log U/ml. Before implementing the assay in clinical practice, additional research in larger patient cohorts should be carried out.
Identifiants
pubmed: 30852396
pii: S1386-6532(19)30048-4
doi: 10.1016/j.jcv.2019.03.003
pii:
doi:
Substances chimiques
Biomarkers
0
Hepatitis B Antibodies
0
Hepatitis B Core Antigens
0
Reagent Kits, Diagnostic
0
Types de publication
Evaluation Study
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1-5Informations de copyright
Copyright © 2019 Elsevier B.V. All rights reserved.