Hepatitis viruses constitute a major public health problem because of the morbidity and mortality associated with the acute and chronic consequences of these infections. Because of the high rate of asymptomatic infection with these viruses, information about the prevalence of these diseases is needed to monitor prevention efforts. By testing a nationally representative sample of the U.S. population, NHANES provides the most reliable estimates of age-specific prevalence needed to evaluate the effectiveness of the strategies to prevent these infections. NHANES testing for markers of infection with hepatitis viruses is used to determine secular trends in infection rates across most age and racial/ethnic groups, and provides a national picture of the epidemiologic determinants of these infections.
Hepatitis is inflammation of the liver most often caused by a virus. Viral hepatitis is a major public health problem of global importance because of the ongoing transmission of viruses that cause the disease and increased morbidity and mortality associated with the acute and chronic consequences of these infections. Global and U.S. goals have been established for elimination of viral hepatitis as a public health threat by 2030 (HHS Healthy People, 2022 and HHS 2020).
In the U.S., the most common types of viral hepatitis are hepatitis A, B, and C. Effective vaccines are available to help prevent hepatitis A and hepatitis B. No vaccine is available for hepatitis C; however, highly effective, well-tolerated treatment can cure hepatitis C virus infection. Hepatitis D virus infection is less common in the U.S. and can occur only among persons with hepatitis B virus infection. Hepatitis E infection also is less common in the U.S. These five hepatitis viruses, also called hepatitides, are well-characterized for detection with laboratory assays and are monitored in U.S. public health surveillance systems.
NHANES viral hepatitis data are used to monitor progress toward goals in Healthy People and the Health and Human Services (HHS) Viral Hepatitis National Strategic Plan, which in turn support U.S. and global viral hepatitis elimination goals (HHS Healthy People, 2022 and National Academies of Sciences, Engineering, and Medicine, 2017). The viral hepatitis laboratory and interview components of NHANES complement data from outbreak, case-based surveillance, vital statistics, health care systems, and cohort studies that can provide timely, detailed, or longitudinal information for subnational geographic areas and disproportionately affected populations, such as people experiencing homelessness or living in correctional facilities; however, these sources lack information available from NHANES, such as race, ethnicity, education, income, and health status and behaviors.
Viral hepatitis data from NHANES are available beginning with NHANES II conducted in 1976-1980 for hepatitis A and hepatitis B, and with NHANES III conducted in 1988-1994 for hepatitis C, hepatitis D, and hepatitis E.
An estimated 300 million people worldwide are persistent carriers of hepatitis B virus (HBV). Infection with HBV results in a wide spectrum of acute and chronic liver diseases that may lead to cirrhosis and hepatocellular carcinoma. Transmission of HBV occurs by percutaneous exposure to blood products and contaminated instruments, sexual contact and perinatally from HBV-infected mothers to their unborn child. In 2022, U.S. vaccination guidelines were updated to recommend hepatitis B vaccination for all infants, unvaccinated children aged <19 years, adults aged 19 through 59 years, and adults aged 60 years and older with risk factors for hepatitis B.
HBV infection produces an array of unique antigens and antibody responses that, in general, follow distinct serological patterns.
Testing for hepatitis B surface antibody contributes information important to distinguish immunity from vaccination among persons who lack antibodies to hepatitis B core antigen. Assay results may be used as an aid in the determination of susceptibility to hepatitis B virus (HBV) infection for individuals prior to or following HBV vaccination, or where vaccination status is unknown.
The hepatitis B surface antibody test is used in NHANES to assess immunity due to vaccination.
Examined participants aged 2 years or older were eligible.
Hepatitis B surface antibody (anti-HBs) is measured using the VITROS Anti-HBs Quantitative assay. The test is performed using the VITROS Anti-HBs Quantitative Reagent Pack and VITROS Immunodiagnostic Products Anti-HBs Calibrators on the VITROS 3600 Immunodiagnostic System.
Refer to the Laboratory Method Files section for a detailed description of the laboratory methods used.
There were no changes to the lab method, lab equipment, or lab site for this component in the NHANES August 2021-August 2023 cycle.
Hepatitis B Surface Antibody Laboratory Procedure Manual (September 2024)
Serum specimens were processed, stored, and shipped to the Division of Viral Hepatitis, National Center for HIV, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, Atlanta, GA for analysis.
Detailed instructions on specimen collection and processing are discussed in the NHANES Laboratory Procedure Manual (LPM). Vials were stored under appropriate frozen (–30°C) conditions until they were shipped to Division of Viral Hepatitis, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention for testing.
The NHANES quality assurance and quality control (QA/QC) protocols meet the 1988 Clinical Laboratory Improvement Amendments mandates. Detailed QA/QC instructions are discussed in the NHANES LPM.
Mobile Examination Centers (MECs)
Laboratory team performance is monitored using several techniques. NCHS and contract consultants use a structured competency assessment evaluation during visits to evaluate both the quality of the laboratory work and the QC procedures. Each laboratory staff member is observed for equipment operation, specimen collection and preparation; testing procedures and constructive feedback are given to each staff member. Formal retraining sessions are conducted annually to ensure that required skill levels were maintained.
Analytical Laboratories
NHANES uses several methods to monitor the quality of the analyses performed by the contract laboratories. In the MEC, these methods include performing blind split samples collected on “dry run” sessions. In addition, contract laboratories randomly perform repeat testing on 2% of all specimens.
The data were reviewed. Incomplete data or improbable values were sent to the performing laboratory for confirmation.
There are over 800 laboratory tests performed on NHANES participants. However, not all participants provided biospecimens or enough volume for all the tests to be performed. The specimen availability can also vary by age or other population characteristics. Analysts should evaluate the extent of missing data in the dataset related to the outcome of interest as well as any predictor variables used in the analyses to determine whether additional re-weighting for item non-response is necessary.
Please refer to the NHANES Analytic Guidelines and the on-line NHANES Tutorial for further details on the use of sample weights and other analytic issues.
Phlebotomy Weights
For the August 2021-August 2023 cycle, analysis of nonresponse patterns for the phlebotomy component in the MEC examination revealed differences by age group and race/ethnicity, among other characteristics. For example, approximately 67% of children aged 1-17 years who were examined in the MEC provided a blood specimen through phlebotomy, while 95% of examined adults aged 18 and older provided a blood specimen. Therefore, an additional phlebotomy weight, WTPH2YR, has been included in this data release to address possible nonresponse bias. Participants who are eligible but did not provide a blood specimen have their phlebotomy weight assigned a value of “0” in their records. The phlebotomy weight should be used for analyses that use variables derived from blood analytes, and is included in all relevant data files.
Demographic and Other Related Variables
The analysis of NHANES laboratory data must be conducted using the appropriate survey design and demographic variables. The NHANES August 2021-August 2023 Demographics File contains demographic data, health indicators, and other related information collected during household interviews as well as the sample design variables. The recommended procedure for variance estimation requires use of stratum and PSU variables (SDMVSTRA and SDMVPSU, respectively) in the demographic data file.
This laboratory data file can be linked to the other NHANES data files using the unique survey participant identifier (i.e., SEQN).
Detection Limits
This data is qualitative. The use of lower limits of detection (LLODs) isn’t applicable.
National Academies of Sciences, Engineering, and Medicine. 2017. A national strategy for the elimination of hepatitis B and C. Washington, DC: The National Academies Press. Available from: http://www.nationalacademies.org/hmd/reports/2017/national-strategy-for-the-elimination-of-hepatitis-b-and-c.aspx
U.S. Department of Health and Human Services. 2020. Viral Hepatitis National Strategic Plan for the United States: A Roadmap to Elimination (2021–2025). Washington, DC. Available from: https://www.hhs.gov/hepatitis/viral-hepatitis-national-strategic-plan/index.html
U.S. Department of Health and Human Services. Healthy People. 2022. Available from: https://health.gov/our-work/national-health-initiatives/healthy-people
| Code or Value | Value Description | Count | Cumulative | Skip to Item |
|---|---|---|---|---|
| 4391.8220579 to 253478.77765 | Range of Values | 7583 | 7583 | |
| 0 | No blood sample provided | 1028 | 8611 | |
| . | Missing | 0 | 8611 |
| Code or Value | Value Description | Count | Cumulative | Skip to Item |
|---|---|---|---|---|
| 1 | Positive | 2042 | 2042 | |
| 2 | Negative | 5324 | 7366 | |
| 3 | Indeterminate | 0 | 7366 | |
| . | Missing | 1245 | 8611 |