Clinical evaluation of a novel and highly sensitive immunoassay for anti‐hepatitis B core antigen using a fully automated immunochemical analyzer

Izumida, Kyo; Kaneko, Atsushi; Takahashi, Kazuya; Kusumoto, Shigeru; Narita, Takuma; Takami, Akiyoshi; Iida, Shinsuke; Aoyagi, Katsumi; Tanaka, Yasuhito

doi:10.1111/hepr.13229

Cited by 5 publications

(3 citation statements)

References 26 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…HBcAb levels can be measured by immunoassays such as Architect Anti HBc II, (Abbott Laboratories, North Chicago, IL, USA) and Lumipulse Presto II (Fujirebio Inc., Tokyo, Japan) [16]. Kyo Izumida et al developed a highly sensitive HBcAb assay suitable for clinical use [17]. It showed an excellent quantitative performance; the quantifiable range spans from 0.005 IU/mL to 1.500 IU/mL.…”

Section: Detection Of Hepatitis B Core Antibody (Hbcab)mentioning

confidence: 99%

Viral Diagnosis of Hepatitis B and Delta: What We Know and What Is Still Required? Specific Focus on Low- and Middle-Income Countries

et al. 2022

View full text Add to dashboard Cite

To achieve the World Health Organization’s (WHO) goals of eradicating viral hepatitis globally by 2030, the regional prevalence and epidemiology of hepatitis B virus (HBV) and hepatitis delta virus (HDV) coinfection must be known in order to implement preventiveon and treatment strategies. HBV/HDV coinfection is considered the most severe form of vira l hepatitis due to it’s rapid progression towards cirrhosis, hepatocellular carcinoma, and liver-related death. The role of simplified diagnosticsis tools for screening and monitoring HBV/HDV-coinfected patients is crucial. Many sophisticated tools for diagnoses have been developed for detection of HBV alone as well as HBV/HDV coinfection. However, these advanced techniques are not widely available in low-income countries and there is no standardization for HDV detection assays, which are used for monitoring the response to antiviral therapy. More accessible and affordable alternative methods, such as rapid diagnostic tests (RDTs), are being developed and validated for equipment-free and specific detection of HBV and HDV. This review will provide some insight into both existing and diagnosis tools under development, their applicability in developing countries and how they could increase screening, patient monitoring and treatment eligibility.

show abstract

Section: Detection Of Hepatitis B Core Antibody (Hbcab)mentioning

confidence: 99%

Viral Diagnosis of Hepatitis B and Delta: What We Know and What Is Still Required? Specific Focus on Low- and Middle-Income Countries

et al. 2022

View full text Add to dashboard Cite

show abstract

“…Antibody to the HBV core protein (AHBc) is a diagnostic marker indicating past exposure or current infection. Recently, several commercially available ELISA-based tests (anti-HBc ELISA, Beijing Wantai Biological, Beijing, China; Lumipulse G HBcAb-N, Fujirebio, Japan [ 139 ]) have been developed to allow quantification of AHBc in serum or plasma. An international reference standard has been prepared for AHBc in IU/mL unitage, allowing standardization and comparison among the various quantitative assays [ 140 ].…”

Section: Novel Hbv Biomarkersmentioning

confidence: 99%

Novel Biomarkers of Hepatitis B Virus and Their Use in Chronic Hepatitis B Patient Management

Osiowy

2021

Viruses

View full text Add to dashboard Cite

Even though an approved vaccine for hepatitis B virus (HBV) is available and widely used, over 257 million individuals worldwide are living with chronic hepatitis B (CHB) who require monitoring of treatment response, viral activity, and disease progression to reduce their risk of HBV-related liver disease. There is currently a lack of predictive markers to guide clinical management and to allow treatment cessation with reduced risk of viral reactivation. Novel HBV biomarkers are in development in an effort to improve the management of people living with CHB, to predict disease outcomes of CHB, and further understand the natural history of HBV. This review focuses on novel HBV biomarkers and their use in the clinical setting, including the description of and methodology for quantification of serum HBV RNA, hepatitis B core-related antigen (HBcrAg), quantitative hepatitis B surface antigen (qHBsAg), including ultrasensitive HBsAg detection, quantitative anti-hepatitis B core antigen (qAHBc), and detection of HBV nucleic acid-related antigen (HBV-NRAg). The utility of these biomarkers in treatment-naïve and treated CHB patients in several clinical situations is further discussed. Novel HBV biomarkers have been observed to provide critical clinical information and show promise for improving patient management and our understanding of the natural history of HBV.

show abstract

“…Izumida et al. developed a highly sensitive anti‐HBc assay, 64 which had 27–81‐fold superior sensitivity than conventional anti‐HBc assays. Remarkably, it showed positivity in preserved samples that had undetectable anti‐HBc by conventional assays and detected low anti‐HBc levels, even after serious immunosuppressive therapies, including autologous hematopoietic stem cell transplantation 64 …”

Section: Topics Of Conventional Biomarkers That Predict Hbv Reactivationmentioning

confidence: 99%

Novel strategies for the early diagnosis of hepatitis B virus reactivation

Matsui

Tanaka

2021

Hepatology Research

Self Cite

View full text Add to dashboard Cite

Hepatitis B virus (HBV) reactivation under systemic chemotherapy or immunosuppressive therapy is a serious complication among HBV‐resolved patients. Some medications, such as more than 2 weeks of corticosteroid therapy, can influence HBV reactivation; therefore, screening tests that measure hepatitis B surface antigen (HBsAg), hepatitis B core antibody, and hepatitis B surface antibody before therapy are required. Additionally, because HBV reactivation has been reported in patients positive for HBsAg treated with immune checkpoint inhibitors (ICIs), the prophylactic administration of nucleos(t)ide analogues prior to administering ICIs is recommended for HBsAg‐positive patients. Under these circumstances, highly sensitive novel biomarkers are expected to be used for the early diagnosis of HBV reactivation. A fully automated high‐sensitivity HBsAg assay (detection limit: 5 mIU/ml) by Lumipulse HBsAg‐HQ, with 10‐fold higher sensitivity than that of conventional assays, is currently used. Furthermore, ultra‐sensitive HBsAg assays using a semi‐automated immune complex transfer chemiluminescence enzyme immunoassay (ICT‐CLEIA; detection limit: 0.5 mIU/ml) have been developed. Recently, a fully automated, novel high‐sensitivity hepatitis B core‐related antigen assay (iTACT‐HBcrAg; cut‐off value: 2.1 Log U/mL) has been developed and reported. The utility of ICT‐CLEIA and iTACT‐HBcrAg for the diagnosis of HBV reactivation appears comparable to the use of HBV DNA. In this review, we provide the latest information related to medications that influence HBV reactivation and recently developed novel biomarkers that predict and monitor HBV reactivation.

show abstract

Clinical evaluation of a novel and highly sensitive immunoassay for anti‐hepatitis B core antigen using a fully automated immunochemical analyzer

Abstract: The clinical efficacy of the newly developed, highly sensitive HBcAb assay would enable the identification of patients at risk of HBV reactivation more accurately.

Cited by 5 publications

References 26 publications

Viral Diagnosis of Hepatitis B and Delta: What We Know and What Is Still Required? Specific Focus on Low- and Middle-Income Countries

Viral Diagnosis of Hepatitis B and Delta: What We Know and What Is Still Required? Specific Focus on Low- and Middle-Income Countries

Novel Biomarkers of Hepatitis B Virus and Their Use in Chronic Hepatitis B Patient Management

Novel strategies for the early diagnosis of hepatitis B virus reactivation

Contact Info

Product

Resources

About