Quantitation of hepatitis B surface antigen by an automated chemiluminescent microparticle immunoassay

Deguchi, Masashi; Yamashita, Naoko; Kagita, Masanori; Asari, Seishi; Iwatani, Yoshinori; Tsuchida, Takahiko; Iinuma, Kazushige; Mushahwar, Isa K.

doi:10.1016/j.jviromet.2003.10.002

Cited by 192 publications

(169 citation statements)

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“…5,13 Briefly, the assay was carried out in two steps: HBsAg present in the sample was bound to antibody to hepatitis B surface antigen (anti-HBs)-coated microparticles, and an acridinium-labeled anti-HBs conjugate was added together with pretrigger and trigger solutions. The products of the resulting chemiluminescent reaction were measured in relative light units.…”

Section: Methodsmentioning

confidence: 99%

“…Recent advances in the development of HBsAg assays with a quantitative, analytical approach have led to the exploration of its potential role in monitoring disease and therapy outcome. Since 2004, when Deguchi et al 5 determined Pearson's correlation coefficient (r) between the quantitative hepatitis B surface antigen (qHBsAg) titer and the serum HBV DNA level to be 0.862, the field of qHBsAg research has been active. Specifically, qHBsAg has shown to be correlated with intrahepatic covalently closed circular DNA (cccDNA), 6,7 and subsequent studies have lent further support to a correlation between qHBsAg and serum HBV DNA levels.…”

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confidence: 99%

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Quantitative hepatitis B surface antigen and hepatitis B e antigen titers in prediction of treatment response to entecavir

et al. 2011

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Quantitative hepatitis B surface antigen (qHBsAg) and quantitative hepatitis B e antigen (qHBeAg) titers are emerging as useful tools for measuring viral loads and for predicting the virological response (VR) and serological response (SR) to pegylated interferon therapy. However, the clinical utility of these assays in patients taking entecavir (ETV) is largely unknown. Treatment-naive patients with chronic hepatitis B (CHB) who were taking ETV for 2 years were enrolled. The qHBsAg and qHBeAg levels were serially measured with the Architect assay. From 95 patients, 60.0% of whom were hepatitis B e antigen-positive [HBeAg(1)], 475 samples were analyzed. The median baseline log hepatitis B virus (HBV) DNA, log qHBsAg, and log qHBeAg values were 6.73 copies/mL (4.04-9.11 copies/mL), 3.58 IU/mL (1.17-5.10 IU/ mL), and 1.71 Paul Ehrlich (PE) IU/mL (20.64 to 2.63 PE IU/mL), respectively. For the prediction of VR (HBV DNA < 60 copies/mL at 24 months) in HBeAg(1) patients, baseline alanine aminotransferase (P 5 0.013), HBV DNA (P 5 0.040), and qHBsAg levels (P 5 0.033) were significant. For the prediction of VR, the area under the curve for the baseline log qHBsAg level was 0.823 (P < 0.001); a cutoff level of 3.98 IU/mL (9550 IU/mL on a nonlogarithmic scale) yielded the highest predictive value with a sensitivity of 86.8% and a specificity of 78.9%. As for SR (HBeAg loss at 24 months), the reduction of qHBeAg was significantly greater in the SR(1) group versus the SR(2) group. The sensitivity and specificity were 75.0% and 89.8%, respectively, with a decline of 1.00 PE IU/mL at 6 months. With ETV therapy, the correlation between HBV DNA and qHBsAg peaked at 6 months in HBeAg(1) patients. Conclusion: Both qHBsAg and qHBeAg decreased significantly with ETV therapy. The baseline qHBsAg levels and the on-treatment decline of qHBeAg in HBeAg(1) patients were proven to be highly useful in predicting VR and SR, respectively. The determination of qHBsAg and qHBeAg can help us to select the appropriate strategy for the management of patients with CHB. However, the dynamic interplay between qHBsAg, qHBeAg, and HBV DNA during antiviral therapy remains to be elucidated. (HEPATOLOGY 2011;53:1486-1493 C hronic infection with hepatitis B virus (HBV) is a worldwide health problem, with more than 400 million people thought to be infected.Moreover, these patients are at increased risk for disease progression to cirrhosis and hepatocellular carcinoma. 1 Large cohort studies have shown that elevated levels of Abbreviations: ALT, alanine aminotransferase; anti-HBs, antibody to hepatitis B surface antigen; AUC, area under the curve; AUROC, area under the receiver operating characteristic

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Section: Methodsmentioning

confidence: 99%

mentioning

confidence: 99%

Quantitative hepatitis B surface antigen and hepatitis B e antigen titers in prediction of treatment response to entecavir

et al. 2011

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“…Initially, HBsAg levels were expressed as serial dilutions of a reference sample from the Paul Ehrlich Institute (Langen, Germany) (44). Recently, new quantitative HBsAg assays have been developed that fulfill the prerequisites of a biomarker: reproducibility, automated quantification with high-throughput platforms, relatively low cost ( o 10% of the cost of a serum HBV DNA assay) and standardization (IU/ml) (45,46). Indeed, the most recent evidence supports the role of HBsAg as a predictive marker for an anti-HBV treatment response (47)(48)(49)(50)(51)(52)(53).…”

Section: Hbsag Revisitedmentioning

confidence: 99%

Quantification of hepatitis B surface antigen: a new concept for the management of chronic hepatitis B

Moucari

Marcellin

2011

Liver International

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HBsAg is a very important clinical test that might not only indicate active hepatitis B virus (HBV) infection but might also be used to predict clinical and treatment outcome. Clearance of HBsAg in patients with chronic HBV infection is associated with a much better clinical outcome, although surveillance for early detection of hepatocellular carcinoma (HCC) should continue. HBV DNA quantification is currently used for selecting candidates for therapy, monitoring response to therapy and detecting the emergence of drug resistance. Assays for HBsAg quantification are less expensive than HBV DNA and fully automated with a high throughput capacity. HBsAg titering may be a useful tool to manage patients with chronic HBV, to more clearly define which patients may, and more importantly, may not, benefit from treatment. Baseline and on-treatment HBsAg quantification may help to refine future treatment algorithms for both immune-modulator therapy and nucleos(t)ide analogues. Both HBV markers provide complementary information on the status of HBV infection. However, the relevance of serum HBsAg levels and its use as a reliable replacement for both covalently closed circular DNA and HBV DNA remain unclear.

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“…A correlation between the levels of circulating HBsAg and the levels of intrahepatic HBV cccDNA has led to renewed interest in the development of sensitive quantitative assays for HBsAg as well as HBeAg [32,33]. Although population distributions have been defined for patients having chronic hepatitis B [32][33][34][35][36], it is clear that much more relevant data can be obtained than by standard qualitative serology.…”

Section: Quantitative Hbeag and Hbsag Assaysmentioning

confidence: 99%

“…Although population distributions have been defined for patients having chronic hepatitis B [32][33][34][35][36], it is clear that much more relevant data can be obtained than by standard qualitative serology. Thus, the use of quantitative HBeAg and HBsAg assays may allow fine-tuning of treatment protocols.…”

Section: Quantitative Hbeag and Hbsag Assaysmentioning

confidence: 99%

New developments in HBV molecular diagnostics and quantitative serology

Bowden

Thompson

2008

Hepatol Int

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New standardized assays for the quantification of hepatitis B virus (HBV) DNA have yielded insights into the association of HBV DNA levels with the relative risk of developing liver disease. Quantification of HBV DNA has also played a role in the management of chronic hepatitis B by allowing criteria to be established for determining patient eligibility for antiviral therapy, monitoring response, and identifying the development of resistance. In addition to serum HBV DNA levels, the HBV genotype may influence disease progression and response to therapy. However, many of the studies that have included genotype assessment do not compare across the range of genotypes, and current management guidelines do not incorporate genotype determination. More recently, quantitative assays for intrahepatic HBV replicative intermediates, as well as hepatitis B e antigen and hepatitis B surface antigen, indicate that these factors may have promise in identifying patients likely to respond to treatment. Additional work is needed to standardize and validate these assays before they can be considered to be of true diagnostic value. A wide variety of research techniques are being used to investigate chronic hepatitis B. Further evaluation is needed to decide which will have the greatest clinical applicability.

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Quantitation of hepatitis B surface antigen by an automated chemiluminescent microparticle immunoassay

Cited by 192 publications

References 5 publications

Quantitative hepatitis B surface antigen and hepatitis B e antigen titers in prediction of treatment response to entecavir

Quantitative hepatitis B surface antigen and hepatitis B e antigen titers in prediction of treatment response to entecavir

Quantification of hepatitis B surface antigen: a new concept for the management of chronic hepatitis B

New developments in HBV molecular diagnostics and quantitative serology

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