Tuesday, May 17, 2022

Hepatitis B Surf Ab Quant 3.1

Multiple Epitopes Of Hepatitis B Virus Surface Antigen Targeted By Human Plasma

Sreya Tarafdar

Plasma Derivatives Branch, Division of Plasma Protein Therapeutics, Office of Tissues and Advanced Therapies, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA

Plasma Derivatives Branch, Division of Plasma Protein Therapeutics, Office of Tissues and Advanced Therapies, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA

Hailing Yan

Plasma Derivatives Branch, Division of Plasma Protein Therapeutics, Office of Tissues and Advanced Therapies, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA

Lilin Zhong

Plasma Derivatives Branch, Division of Plasma Protein Therapeutics, Office of Tissues and Advanced Therapies, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA

Lu Deng

Plasma Derivatives Branch, Division of Plasma Protein Therapeutics, Office of Tissues and Advanced Therapies, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA

Yanqun Xu

Plasma Derivatives Branch, Division of Plasma Protein Therapeutics, Office of Tissues and Advanced Therapies, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA

Yong He

Evi Struble

Prevalence And Trends By Select Characteristics

Overall, from 2003 to 2014, the prevalence of protective levels of anti-HBs among adults at high risk aged 1849 years was 23.4% . This was significantly lower than the prevalence among adult participants of the same age during the same time period who were not at high risk . Significant differences within subgroups in overall hepatitis B protection prevalence from 2003 to 2014 were observed as well . Prevalence was significantly higher among females compared with males and among adults aged 1829 years compared with adults aged 3039 years and those aged 4049 years . Adults educated beyond high school were more likely to be protected than those with a high school education or less . Additionally, adults who were never married were more likely to be protected than those who were married. Last, adults who had health insurance and those who reported receiving hepatitis A vaccination were more likely than their counterparts to be protected from HBV infection. Notably, the prevalence of protective levels of anti-HBs across all population subgroups from 2003 to 2014 was relatively low, ranging from 13.6% to 43.8%.

Prevalence and Prevalence Ratios of Having Protective Levels of Hepatitis B Virus Antibody Among Adults Aged 1849 Years at High Risk of HBV Infection by Sociodemographic and Healthcare-related Characteristic, United States, 20032014

Characteristic .
Characteristic .

Predictors Of Protective Levels Of Hepatitis B Surface Antibody

Findings from our multivariable analyses revealed several significant results and confirmed a number of our bivariate findings. Younger adults aged 1829 and 3039 years were more likely to have protective levels of anti-HBs compared with adults aged 4049 years. Females had higher odds than males of being protected. Compared with non-Hispanic whites, non-Hispanic blacks were less likely to have protective levels of anti-HBs. Adults with greater than a high school education had increased odds of being protected from hepatitis B compared with those with a high school education or less. Finally, adults with health insurance compared with those without health insurance and those who reported having received hepatitis A vaccine compared with those who did not were more likely to be protected from hepatitis B.

Multivariate Logistic Regression Estimates of Characteristics Predicting the Likelihood of Having Protective Levels of Hepatitis B Virus Antibody Among Adults Aged 1849 Years at High Risk of HBV Infection, United States, 20032014

Characteristic .

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Discusses Physiology Pathophysiology And General Clinical Aspects As They Relate To A Laboratory Test

Hepatitis B virus infection, also known as serum hepatitis, is endemic throughout the world. The infection is spread primarily through blood transfusion or percutaneous contact with infected blood products, such as sharing of needles among injection drug users. The virus is also found in virtually every type of human body fluid and has been known to be spread through oral and genital contact. HBV can be transmitted from mother to child during delivery through contact with blood and vaginal secretions, but it is not commonly transmitted via the transplacental route.

The incubation period for HBV infection averages 60 to 90 days . Common symptoms include malaise, fever, gastroenteritis, and jaundice . After acute infection, HBV infection becomes chronic in 30% to 90% of infected children younger than 5 years of age and in 5% to 10% of infected individuals age 5 or older. Some of these chronic carriers are asymptomatic, while others progress to chronic liver disease, including cirrhosis and hepatocellular carcinoma.

Hepatitis B surface antigen is the first serologic marker, appearing in the serum 6 to 16 weeks following HBV infection. In acute cases, HBsAg usually disappears 1 to 2 months after the onset of symptoms with the appearance of hepatitis B surface antibody . Anti-HBs also appears as the immune response following hepatitis B vaccination.

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Definition Of Hcc Occurrence Cirrhosis And Significant Fibrosis

HCC was diagnosed according to the guidelines of the American Association for the Study of Liver Disease. The presence of cirrhosis was reviewed according to imaging findings of cirrhotic hepatic change and/or clinical criteria indicating portal hypertension, such as the presence of ascites, esophageal or gastric varix, or splenomegaly with thrombocytopenia.

Hepatic fibrosis was defined using a noninvasive prediction model Fibrosis-4 index. The equation for FIB-4 index is as follows

FIB-4=age x AST / x 1/2)

Subjects with FIB-4> 1.45 were regarded as those who have high probability of advanced fibrosis,.

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Definition Of Groups And Outcome Measures

The coexistence of HBsAg and anti-HBs was defined by the simultaneous positivity for both HBsAg and anti-HBs. The coexistence group included chronic hepatitis B patients who were positive for both HBsAg and anti-HBs during follow-up. The transient or intermittent coexistence of HBsAg and anti-HBs during follow-up was also included in the coexistence group. The dynamic change of HBsAg and anti-HBs of the patients in coexistence group is presented in Supplementary Fig. . The control group include patients who never experienced coexistence of HBsAg and anti-HBs during follow-up.

The primary outcome was HCC incidence. Secondary outcomes were HBsAg seroclearance and all-cause mortality. HBsAg seroclearance was defined as the loss of serum HBsAg, not related to liver transplantation. The follow-up duration for HCC occurrence was calculated from the time of initial visit to the time of last evaluation of the image or the diagnosis of HCC. The follow-up duration for HBsAg seroclearance was calculated from the time of initial evaluation of HBsAg to the time of last HBsAg evaluation or HBsAg seroclearance. Predictors for outcomes were evaluated. All-cause mortality was evaluated in all subjects using the survival data provided by the National Micro Data Service System .

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Ethical Approval And Informed Consent

This study protocol conformed to the ethical guidelines of the 1975 Declaration of Helsinki and was approved by the Institutional Review Board of Seoul National University Hospital . The requirement for informed consent from subjects was waived because the researchers accessed only deidentified database entries for analytical purposes.

Discusses Conditions That May Cause Diagnostic Confusion Including Improper Specimen Collection And Handling Inappropriate Test Selection And Interfering Substances

Individuals who have received blood component therapies , plasma, or intravenous immunoglobulin infusion) in the previous 3 to 6 months may have false-positive hepatitis B surface antibody results due to passive transfer of anti-HBs present in these products.

Individuals possessing IgM anti-rubella virus may have falsely high results with the VITROS Anti-HBs quantitative test.

Anti-HBs levels from past hepatitis B or hepatitis B virus vaccination may fall below detectable levels over time.

A positive anti-HBs result does not exclude infection by another hepatitis virus.

Performance characteristics have not been established for the following specimen characteristics:

-Grossly icteric

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Understanding Of Lab Tests Results

Please visit the site associated with The American Association for Clinical Chemistry for better understanding of tests. There you will find the most detailed and full information regarding lab tests. In common questions tab you will find answers on the most common questions.

In addition, you can use a special form to ask the question. It is useful, if there is no answer on your question on the web site. A laboratory scientist will answer your question. It is a part of voluntary service provided by the American Society for Clinical Laboratory Science.

Baseline Characteristics Of Enrolled Participants

Between 1997 and 1999, 2436 newborns who received a full course of primary vaccination were initially recruited in the study cohort, and 1551 participants were followed in 2017. Of the 1551 individuals, 199 individuals with a history of booster vaccination were excluded, and 1352 participants were included in the final analysis. Of the 1352 participants, 616 were male, and the average age of the enrolled participants was 19.3years . All participants completed primary vaccination at day 187.2 after birth, resulting in an average of 18.8 follow-up years.

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What Is A Hepatitis B Surface Antibody Test

Hepatitis B surface antibody test is part of a panel of blood tests to diagnose HBV infection. Hepatitis B surface antibody test determines the presence and quantity of anti-HBs in the blood serum, which can indicate protection from HBV infection.

Hepatitis B disease affects the liver and commonly spreads through body fluids such as blood, semen, and vaginal secretions.

Hepatitis B Vaccine And Surface Antibody Titer Faqs

PLEASE NOTE: This is program specific some programs require 3 Hepatitis B vaccines AND a positive Hepatitis B Surface Antibody titer while others will accept 3 vaccines OR a titer. Please read the information in your CastleBranch account carefully so that you know exactly what you need to meet your programs requirements. If you have any questions, please email and a team member will respond.

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In Vivo Hbv Suppression By Potent Broadly Neutralizing Antibody Bc1187

To determine whether potent HBV neutralizers from natural controllers can stably suppress HBV viremia in vivo, HBV-carrier mice were treated for 17 d with Bc1.187 antibody . Viremic mice experienced a decrease in circulating HBsAg levels upon treatment with Bc1.187 but not with the isotype control . However, the development of murine anti-human IgG antibodies rapidly altered therapy effectiveness . To overcome or limit ADA production, we generated a chimeric version of Bc1.187 by combining the antibodys variable domains with the murine Ig2a and IgK constant regions. The chimeric Bc1.187 antibody had a serum half-life of 3.9 d in nontransduced wild-type mice , and led to reproducible viremia drops when administrated weekly in HBV-carrier mice . 16 d of treatment with 0.5 mg i.v. injections of c-Bc1.187 every 2 d but not control antibody led to a loss of circulating HBsAg in all mice from day 4 with an average 2.5 log10 fold decrease compared with the set-point . During c-Bc1.187 therapy, serum HBV DNA content was also drastically diminished by an average 2.5 log10 fold and reached the detection limit by day 21 in all but one mouse . HBsAg and HBV viremia were still suppressed for 2 wk after the last antibody injection before rising back to baseline levels . As expected in this model, serum levels of HBe antigen, a surrogate marker for viral replication, remained unchanged during therapy .

What Is The Normal Range For Hepatitis B Surface Antibody

  • What Is the Normal Range for Hepatitis B Surface Antibody? Center
  • Hepatitis B surface antibodies are measured in blood samples in milli-International Units/milliliter mIU/mL). The ranges for hepatitis B surface antibodies are:

    • Anti-HBs greater than 10-12 mIU/mL: Protected against hepatitis B virus infection, either from vaccination or successful recovery from a previous HBV infection.
    • Anti-HBs less than 5 mIU/mL: Negative for HBV infection, but susceptible and hence requires vaccination.
    • Anti-HBs from 5-12 mIU/mL: Inconclusive results and the test should be repeated.

    However, there is no standardization of these values so it is advisable to check the manufacturers values it is the reason values are mainly reported as positive or negative.

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    Peptides Proteins And Anti

    All peptides were synthesized by GenScript, Inc. The wildtype HBsAg peptides and their corresponding mutants were biotinylated at the N-terminus with the sequence SGSG as a linker between the peptide and the biotin tag, while all other peptides carried the biotin label at their C-terminus with GGGSAK as a linker between the peptide and the biotin tag. Recombinant HBsAg proteins of subtypes ad and ay, which were expressed in Saccharomyces cerevisiae, were purchased from Bio-Rad Laboratories . HBIG lots made by various FDA-licensed manufacturers were obtained from the National Institutes of Health Clinical Center Pharmacy and used in this study as the source materials of anti-HBs antibodies. All these HBIG lots had met the lot release potency specification of â¥312 IU/ml anti-HBs.

    What Do Hepatitis B Test Results Mean

    Hepatitis B test results help determine if HBV infection is negative or positive, and if positive, whether the infection is acute or chronic, or if recovery is complete. A combination of results are considered to identify and classify HBV infection status.

    The following are some interpretations of hepatitis B test results:

    Table: Hepatitis B test results and interpretations

    Test

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    Hepatitis B Blood Tests

    The Hepatitis B Panel of Blood Tests

    Only one sample of blood is needed for a hepatitis B blood test, but the Hepatitis B Panel includes three parts. All three test results are needed to fully understand whether a person is infected or not. Below is an explanation of the 3-part Hepatitis B Panel of blood test results.

  • HBsAg A positive or reactive HBsAg test result means that the person is infected with hepatitis B. This test can detect the actual presence of the hepatitis B virus in your blood. If a person tests positive, then further testing is needed to determine if this is a new acute infection or a chronic hepatitis B infection. A positive HBsAg test result means that you are infected and can spread the hepatitis B virus to others through your blood.
  • anti-HBs or HBsAb A positive or reactive anti-HBs test result indicates that a person is protected against the hepatitis B virus. This protection can be the result of receiving the hepatitis B vaccine or successfully recovering from a past hepatitis B infection. This test is not routinely included in blood bank screenings. A positive anti-HBs test result means you are immune and protected against the hepatitis B virus and cannot be infected. You are not infected and cannot spread hepatitis B to others.
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    Kinetics And Risk Of De Novo Hepatitis B Infection In Hbsagnegative Patients Undergoing Cytotoxic Chemotherapy

    • CheeKin HuiCorrespondenceAddress requests for reprints to: CheeKin Hui, MD, University of Hong Kong, Queen Mary Hospital, Department of Medicine, 102 Pokfulam Road, Hong Kong SAR, China. fax: 2281 84030.Centre For The Study of Liver Diseases, The University of Hong Kong, Hong Kong SAR, ChinaResearch Centre For Infection and Immunity, The University of Hong Kong, Hong Kong SAR, China
    • HaiYing ZhangAffiliationsCentre For The Study of Liver Diseases, The University of Hong Kong, Hong Kong SAR, ChinaResearch Centre For Infection and Immunity, The University of Hong Kong, Hong Kong SAR, China
    • YuiHung YuengAffiliationsCentre For The Study of Liver Diseases, The University of Hong Kong, Hong Kong SAR, ChinaResearch Centre For Infection and Immunity, The University of Hong Kong, Hong Kong SAR, China
    • John M. LukAffiliationsCentre For The Study of Liver Diseases, The University of Hong Kong, Hong Kong SAR, ChinaDepartment of Surgery, Queen Mary Hospital, The University of Hong Kong, Hong Kong SAR, China
    • George K.K. LauAffiliationsCentre For The Study of Liver Diseases, The University of Hong Kong, Hong Kong SAR, ChinaResearch Centre For Infection and Immunity, The University of Hong Kong, Hong Kong SAR, China

    Background & Aims:Methods:Results:

    Abbreviations used in this paper:

    Lancet.J Hepatol.

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    Clinical And Laboratory Assessments

    Demographic data, medication history including antiviral agents and comorbidities such as malignancy were assessed based on electronic medical records.

    Laboratory tests included assessments of serology associated with HBV infection, liver function, AFP levels, platelet counts, and antibodies against hepatitis C virus and human immunodeficiency virus. Serologic markers for HBV including HBsAg, anti-HBs, hepatitis B e antigen , and anti-HBe were assessed by chemiluminescent microparticle immunoassays . The concentration of HBsAg was determined using a previously generated Architect HBsAg calibration curve , and the samples with higher than 250 IU/ml HBsAg levels were diluted to 1:5001:1000. By June 2010, qHBsAg more than 250 were expressed as > 250 IU/ml without presenting an exact value. Thus, we divided subjects into 2 groups as those with qHBsAg> 250 IU/ml and those with qHBsAg250 IU/ml in this study.

    Serum HBV DNA levels were measured with Roche COBAS TaqMan quantitative PCR assay, which has a low detection limit of 20 IU/mL. The threshold for anti-HBs positivity was an anti-HBs titer > 10 IU/mL. Blood samples were collected before 10:00 AM after the patients had completed a 12-h overnight fast. All laboratory tests were conducted using standard methods.

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