Analytical validation of hepatitis B core‐related antigen (HBcrAg) using dried blood spots (DBS)

Shimakawa, Yusuke; Vernoux, Laura; Gabassi, Audrey; Mercier‐Delarue, Séverine; Vincent, Jeanne Perpétue; Simon, François; Maylin, Sarah

doi:10.1111/jvh.13489

Cited by 11 publications

(14 citation statements)

References 31 publications

(54 reference statements)

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“…DBS have also been used in the HBcrAg assay, showing that HBcrAg correlated strongly with HBV DNA levels for genotypes A–E in individuals with high viral load, suggesting that DBS might be useful in resource-limited settings with limited access to NAT 45 . However, the assay used to measure HBcrAg, LUMIPULSE chemiluminescent enzyme immunoassay (Fujirebio, Tokyo, Japan), is currently not widely available.…”

Section: Point-of-care Testing: An Unmet Needmentioning

confidence: 99%

“…The current commercial HBcrAg assay, the chemiluminescent enzyme immunoassay (CLEIA; Lumipulse G HBcrAg, Fujirebio), is for research use only. It detects a combination of HBcAg, HBeAg (both free and in the HBeAg–HBe antibody complex) and precore proteins in the blood following sodium dodecyl sulfate and heat treatment 103 – 105 and has been validated for DBS 45 . The relative contribution of each component of HBcrAg in this assay has not been elucidated and affects the accuracy and utility of HBcrAg as a biomarker for cccDNA.…”

Section: Novel or Emerging Biomarkersmentioning

confidence: 99%

See 1 more Smart Citation

A roadmap for serum biomarkers for hepatitis B virus: current status and future outlook

Kramvis

Chang

Dandri

et al. 2022

Nat Rev Gastroenterol Hepatol

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Globally, 296 million people are infected with hepatitis B virus (HBV), and approximately one million people die annually from HBV-related causes, including liver cancer. Although there is a preventative vaccine and antiviral therapies suppressing HBV replication, there is no cure. Intensive efforts are under way to develop curative HBV therapies. Currently, only a few biomarkers are available for monitoring or predicting HBV disease progression and treatment response. As new therapies become available, new biomarkers to monitor viral and host responses are urgently needed. In October 2020, the International Coalition to Eliminate Hepatitis B Virus (ICE-HBV) held a virtual and interactive workshop on HBV biomarkers endorsed by the International HBV Meeting. Various stakeholders from academia, clinical practice and the pharmaceutical industry, with complementary expertise, presented and participated in panel discussions. The clinical utility of both classic and emerging viral and immunological serum biomarkers with respect to the course of infection, disease progression, and response to current and emerging treatments was appraised. The latest advances were discussed, and knowledge gaps in understanding and interpretation of HBV biomarkers were identified. This Roadmap summarizes the strengths, weaknesses, opportunities and challenges of HBV biomarkers.

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Section: Point-of-care Testing: An Unmet Needmentioning

confidence: 99%

Section: Novel or Emerging Biomarkersmentioning

confidence: 99%

A roadmap for serum biomarkers for hepatitis B virus: current status and future outlook

Kramvis

Chang

Dandri

et al. 2022

Nat Rev Gastroenterol Hepatol

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“…[18][19][20][21][22][23][24][25][26][27][28][29][30][31] Fourteen studies (n = 14) examined populations with known HBV, HCV and/or HIV status. 17,[32][33][34][35][36][37][38][39][40][41][42][43] Twelve articles (n = 12) examined patients attending or staying in hospitals, clinics and health centres. 19,[44][45][46][47][48][49][50][51][52][53][54] Eleven studies (n = 11) investigated populations engaged in risky behaviours that increase their susceptibility to blood-borne viruses (BBVs) like HBV.…”

Section: F I G U R Ementioning

confidence: 99%

The role of dried blood spot tests in the detection of hepatitis B infection: A systematic review

Virtudazo,

Aquino,

Arellano

et al. 2023

Journal of Viral Hepatitis

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Hepatitis B remains a public health problem worldwide despite vaccine availability. Although the existing diagnostic tools help detect the infection, logistics support and limited resources and technologies affect their usefulness and reliability in developing countries. This systematic review evaluated the performance of dried blood spots (DBS) as a collection and storage tool for diagnosing an hepatitis B virus (HBV) infection. A comprehensive search using OVID, Scopus and CINAHL databases was performed to collate articles published up to April 2023 that detected Hepatitis B infections using DBS. Five reviewers independently performed identification, screening, quality assessment and data extraction. A qualitative synthesis of the included studies was conducted. Of the 402 articles, 78 met the inclusion criteria. The results show that most studies focused on populations with known HBV, HCV and/or HIV status. Approximately half (49%) of the included studies utilized the Whatman Protein Saver Card for DBS collection. The DBS samples were then predominantly stored in room temperature conditions. In line with this, storage conditions influenced the concentration and stability of the analyte from the DBS samples, affecting the accuracy of downstream diagnostic methods. ELISA methods, using hepatitis B surface antigen (HBsAg) as an HBV marker, were the most widely used diagnostic tool for detecting HBV infection in DBS samples. The simplicity and cost‐effectiveness of the ELISA technique highlight its potential to be used in low‐resource settings. In line with this, the detection of HBsAg using an ELISA immunoassay had higher sensitivity (85.6%–100%), and specificity (95%–100%) ranges as compared to other target molecules and methods. Although this review only performed a qualitative analysis, DBS offers a promising method for collecting and storing blood samples; however, the standardization of sampling, storing conditions and diagnostic techniques is required to ensure sustainable application.

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“…Consequently, using a simplified treatment approach, HBcrAg alone demonstrated an AUROC of 0.91 [95% CI; 0.88-0.95]) with a sensitivity of 96.6% and specificity of 85.8%. HBcrAg still requires laboratory infrastructure, but it may be more affordable, and evidence exists that validates its performance using dried blood spot testing [36]. There is now supportive evidence for its value in discriminating those in the immune control/chronic infection versus immune reactive/chronic hepatitis phase of infection in HBeAg-negative patients [37].…”

Section: Disparities In the Treatment Of Chronic Hepatitis B Virus In...mentioning

confidence: 99%

Global Disparities in Hepatitis B Elimination—A Focus on Africa

Sonderup

Spearman

2022

Viruses

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In 2016, WHO member states at the World Health Assembly adopted a Global Health Sector Strategy that included a policy of eliminating viral hepatitis. Clear targets were established to assist in achieving this by 2030. The strategy, while achievable, has exposed existing global disparities in healthcare systems and their ability to implement such policies. Compounding this, the regions with most disparity are also those where the hepatitis B prevalence and disease burden are the greatest. Foundational to hepatitis B elimination is the identification of both those with chronic infection and crucially pregnant women, and primary prevention through vaccination. Vaccination, including the birth dose and full three-dose coverage, is key, but complete mother-to-child transmission prevention includes reducing the maternal hepatitis B viral load in the third trimester where appropriate. Innovations and simplified tools exist in order to achieve elimination, but what is desperately required is the will to implement these strategies through the support of appropriate investment and funding. Without this, disparities will continue.

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Analytical validation of hepatitis B core‐related antigen (HBcrAg) using dried blood spots (DBS)

Abstract: This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.

Cited by 11 publications

References 31 publications

A roadmap for serum biomarkers for hepatitis B virus: current status and future outlook

A roadmap for serum biomarkers for hepatitis B virus: current status and future outlook

The role of dried blood spot tests in the detection of hepatitis B infection: A systematic review

Global Disparities in Hepatitis B Elimination—A Focus on Africa

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