Comparison of the elecsys HBsAg II assay and the architect assay for quantification of hepatitis B surface antigen in chronic hepatitis B patients

Liao, Chen-Chih; Hsu, Chen-Ming; Gu, Po-Wen; Yeh, Chau‐Ting; Lin, Shi‐Ming; Chiu, Cheng-Tang

doi:10.4103/2319-4170.143485

Cited by 10 publications

(4 citation statements)

References 22 publications

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“…Detection of the surface antigen (HBsAg), the major HBV envelope protein, is pivotal for diagnosis of HBV infection and routinely used for testing of individuals with suspected HBV infection, therapeutic monitoring of infected subjects and screening of blood donors [9, 10]. Numerous variations in the HBV S gene give rise to a diversity of HBsAg mutations which are associated with immune escape, occult infection, and diagnostic escape [11, 12].…”

Section: Introductionmentioning

confidence: 99%

Ultra-deep sequencing reveals high prevalence and broad structural diversity of hepatitis B surface antigen mutations in a global population

Gencay

Hübner²,

Gohl³

et al. 2017

PLoS ONE

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The diversity of the hepatitis B surface antigen (HBsAg) has a significant impact on the performance of diagnostic screening tests and the clinical outcome of hepatitis B infection. Neutralizing or diagnostic antibodies against the HBsAg are directed towards its highly conserved major hydrophilic region (MHR), in particular towards its “a” determinant subdomain. Here, we explored, on a global scale, the genetic diversity of the HBsAg MHR in a large, multi-ethnic cohort of randomly selected subjects with HBV infection from four continents. A total of 1553 HBsAg positive blood samples of subjects originating from 20 different countries across Africa, America, Asia and central Europe were characterized for amino acid variation in the MHR. Using highly sensitive ultra-deep sequencing, we found 72.8% of the successfully sequenced subjects (n = 1391) demonstrated amino acid sequence variation in the HBsAg MHR. This indicates that the global variation frequency in the HBsAg MHR is threefold higher than previously reported. The majority of the amino acid mutations were found in the HBV genotypes B (28.9%) and C (25.4%). Collectively, we identified 345 distinct amino acid mutations in the MHR. Among these, we report 62 previously unknown mutations, which extends the worldwide pool of currently known HBsAg MHR mutations by 22%. Importantly, topological analysis identified the “a” determinant upstream flanking region as the structurally most diverse subdomain of the HBsAg MHR. The highest prevalence of “a” determinant region mutations was observed in subjects from Asia, followed by the African, American and European cohorts, respectively. Finally, we found that more than half (59.3%) of all HBV subjects investigated carried multiple MHR mutations. Together, this worldwide ultra-deep sequencing based genotyping study reveals that the global prevalence and structural complexity of variation in the hepatitis B surface antigen have, to date, been significantly underappreciated.

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Section: Introductionmentioning

confidence: 99%

Ultra-deep sequencing reveals high prevalence and broad structural diversity of hepatitis B surface antigen mutations in a global population

Gencay

Hübner²,

Gohl³

et al. 2017

PLoS ONE

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“…Currently, there are three quantitative assays for HBsAg measurement: Architect HBsAg QT (Abbott Diagnostics), Elecsys HBsAg II Quant (Roche Diagnostics) and DiaSorin Liaison XL. All assays provide measurements that correlate well with each other (Burdino et al, 2014;Liao et al, 2015). The Architect assay is capable of quantifying HBsAg concentrations ranging from 0.4 to 250 IU/mL (Deguchi et al, 2004).…”

Section: Quantificationmentioning

confidence: 97%

Viral Biomarkers for Hepatitis B Virus-Related Hepatocellular Carcinoma Occurrence and Recurrence

et al. 2021

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Hepatocellular carcinoma (HCC) is the sixth most common cancer worldwide and the fourth leading cause of cancer-related death. The most common risk factor for developing HCC is chronic infection with hepatitis B virus (HBV). Early stages of HBV-related HCC (HBV-HCC) are generally asymptomatic. Moreover, while serum alpha-fetoprotein (AFP) and abdominal ultrasound are widely used to screen for HCC, they have poor sensitivity. Thus, HBV-HCC is frequently diagnosed at an advanced stage, in which there are limited treatment options and high mortality rates. Serum biomarkers with high sensitivity and specificity are crucial for earlier diagnosis of HCC and improving survival rates. As viral–host interactions are key determinants of pathogenesis, viral biomarkers may add greater diagnostic power for HCC than host biomarkers alone. In this review, we summarize recent research on using virus-derived biomarkers for predicting HCC occurrence and recurrence; including circulating viral DNA, RNA transcripts, and viral proteins. Combining these viral biomarkers with AFP and abdominal ultrasound could improve sensitivity and specificity of early diagnosis, increasing the survival of patients with HBV-HCC. In the future, as the mechanisms that drive HBV-HCC to become clearer, new biomarkers may be identified which can further improve early diagnosis of HBV-HCC.

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“…The quantification of HBsAg in the past was performed for research purposes by serial serum dilutions that allowed the determination of its titer with qualitative assays [ 18 ]. Currently, HBsAg quantification (qHBsAg) in serum is measured in international units per milliliter (IU/mL) on the same instruments that are used for routine serology, but with different reagents and in most cases with on board dilution of the sample [ 19 , 20 , 21 ]. The lower limit of HBsAg detection for the majority of the quantitative assays is 0.05 IU/mL in undiluted samples, which is higher than the cut off of the respective qualitative assays.…”

Section: Viral Biomarkersmentioning

confidence: 99%

“…Automated HBsAg quantification has been proven to be highly reproducible and the results between different analyzers show very good correlation [ 19 ]. Nevertheless, it is recommended to employ the same assay for monitoring, since differences, especially in the low ranges, might be of importance.…”

Section: Viral Biomarkersmentioning

confidence: 99%

Viral Biomarkers in Chronic HBeAg Negative HBV Infection

Hadziyannis

Laras

2018

Genes

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Viral biomarkers are important tools for monitoring chronic hepatitis B virus (HBV) hepatitis B early antigen (HBeAg) negative infection, both in its natural course as well as during and after treatment. The biomarkers consist of antibodies against viral epitopes, viral proteins, and molecular surrogate markers of the quantity and transcriptional activity of the stable episomal HBV covalently closed circular DNA (cccDNA) which is located in the nuclei of the infected hepatocytes. HBV deoxyribonucleic acid (DNA) or else viral load measurement in plasma or serum is a marker of HBV replication of major clinical importance. HBV DNA is used for staging and treatment monitoring as described in international scientific guidelines. Quantification of HBV antigens, mainly hepatitis B surface antigen (HBsAg) as well as Hepatitis B core related antigen (HBcrAg), play an important yet secondary role, especially in cases of low or undetectable HBV DNA and has been evaluated for the classification of the inactive carrier state, as a predictor of subsequent HBsAg clearance, treatment outcome, and development of hepatocellular carcinoma (HCC). The measurement of the replicative intermediate HBV RNA in serum is currently evaluated and may also prove to be a significant biomarker particularly in patients treated with nucleot(s)ide analogs. This review focuses on the viral biomarkers mentioned above and their role in HBV, HBeAg negative, infection.

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Comparison of the elecsys HBsAg II assay and the architect assay for quantification of hepatitis B surface antigen in chronic hepatitis B patients

Cited by 10 publications

References 22 publications

Ultra-deep sequencing reveals high prevalence and broad structural diversity of hepatitis B surface antigen mutations in a global population

Ultra-deep sequencing reveals high prevalence and broad structural diversity of hepatitis B surface antigen mutations in a global population

Viral Biomarkers for Hepatitis B Virus-Related Hepatocellular Carcinoma Occurrence and Recurrence

Viral Biomarkers in Chronic HBeAg Negative HBV Infection

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