J Clin Virol. 2019 Mar 4;114:1-5. doi: 10.1016/j.jcv.2019.03.003. [Epub ahead of print]
Diagnostic and analytical performance of the hepatitis B core related antigen immunoassay in hepatitis B patients.
van Halewijn GJ1, Geurtsvankessel CH2, Klaasse J2, van Oord GW3, de Knegt RJ3, van Campenhout MJ3, Boonstra A3, van der Eijk AA4.
Author information
1
Department of Gastroenterology and Hepatology, Erasmus MC, University Medical Center Rotterdam, the Netherlands; Department of Viroscience, Erasmus MC, University Medical Center Rotterdam, the Netherlands.
2
Department of Viroscience, Erasmus MC, University Medical Center Rotterdam, the Netherlands.
3
Department of Gastroenterology and Hepatology, Erasmus MC, University Medical Center Rotterdam, the Netherlands.
4
Department of Viroscience, Erasmus MC, University Medical Center Rotterdam, the Netherlands. Electronic address: [email protected].
Abstract
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.
Lumipulse G HBcrAg免疫测定提供了在1：100和1：10,000稀释度下的线性测量。 54个样本中的6个在急性CMV，EBV和HEV感染的血清中显示出非特异性反应性，其中2个> 3log U / ml。在HBeAg阳性患者中，在治疗和未治疗以及免疫功能低下的患者中测量最高水平的HBcrAg。未治疗的患者在无活性载体期具有相对低的血清HBcrAg水平，其在进展为HBeAg阴性肝炎期后增加。此外，我们发现HBcrAg用于区分已解决的HBV感染患者和对单独抗HBc的假阳性反应的适用性是有限的。
结论：