Does the ultrasensitive HBsAg Next assay enhance Hepatitis B diagnosis? An evaluation of analytical performances.

Autor: Bourdin J; AP-HP, Hôpital Saint Louis, Laboratoire de Virologie, Paris, France., Sellier P; AP-HP, Hôpital Lariboisière, Service de Maladies Infectieuses, Paris, France., Salmona M; AP-HP, Hôpital Saint Louis, Laboratoire de Virologie, Paris, France; Université Paris Cité INSERM U976, Paris, France., Lascoux-Combe C; AP-HP, Hôpital Saint Louis, Service de Maladies Infectieuses, Paris, France., Delaugerre C; AP-HP, Hôpital Saint Louis, Laboratoire de Virologie, Paris, France; Université Paris Cité, Inserm U944, Biology of Emerging Viruses, Paris, France., Maylin S; AP-HP, Hôpital Saint Louis, Laboratoire de Virologie, Paris, France. Electronic address: sarah.maylin@aphp.fr.
Jazyk: angličtina
Zdroj: Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology [J Clin Virol] 2024 Oct; Vol. 174, pp. 105707. Date of Electronic Publication: 2024 Jun 22.
DOI: 10.1016/j.jcv.2024.105707
Abstrakt: Background: Accurate laboratory confirmation for Hepatitis B diagnosis and monitoring are crucial. Recently an ultrasensitive immunoassay test, the HBsAg Next (HBsAgNx), has been reported approximately eight times more sensitive than current HBsAg assays. The aim of our study was to assess the analytical performances of this new test.
Methodology: 253 clinical samples from Saint Louis University Hospital were analyzed, splitted into four panels: (1) routine prospectively screening serums (n = 196), (2) retrospective serum samples before HBV reactivation (HBV-R) (n = 18), (3) occult HBV infection (OBI) (n = 10) and (4) a selection of wild type HBV genotypes (n = 29) RESULTS: Panel 1, showed robust agreement with the HBsAg Qualitative II (HBsAgQII) assay (Cohen's kappa = 0.83). Despite this agreement, 7 false positive with the HBsAgQII assay were found negative with HBsAgNx. One OBI was detected only with HBsAgNx. Panel 2 showed potential time savings in diagnosing HBV-R using HBsAgNx among 4/18 HBsAg positives samples. Panel 3 highlighted the ability of HBsAgNx to detect HBsAg in OBI patients defined by negative for HBsAg with HBsAgQII assay and positive for HBV DNA. Furthermore, the HBsAgNx assay detected all different genotypes.
Conclusion: The study highlights the effectiveness of the HBsAgNx assay, showing its performance. It excels in detecting weakly positive samples and addressing challenging cases. HBsAgNx assay demonstrates promising analytical performances, with improved sensitivity and specificity compared to standard HBsAgQII assay, able to detect all genotypes. Its potential impact on early detecting and monitoring reactivations, and occult infections could be very useful in clinical practice.
Competing Interests: Declaration of competing interest All authors declare no conflict of interest for this work.
(Copyright © 2024 Elsevier B.V. All rights reserved.)
Databáze: MEDLINE
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