Hepatitis viruses constitute a major public health problem because of the morbidity and mortality associated with the acute and chronic consequences of these infections. New immunization strategies have been developed to eliminate the spread of the hepatitis B virus (HBV) and the hepatitis A virus (HAV) in the United States. Recommendations have also been developed for the prevention and control of the hepatitis C virus (HCV) infection. 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 will provide the most reliable estimates of age-specific prevalence needed to evaluate the effectiveness of the strategies to prevent these infections. In addition, NHANES provides the means to better define the epidemiology of other hepatitis viruses. NHANES testing for markers of infection with hepatitis viruses will be used to determine secular trends in infection rates across most age and racial/ethnic groups, and will provide a national picture of the epidemiologic determinants of these infections.
Examined participants aged 2 years and older were eligible.
The VITROS Anti-HAV Total assay is performed using the VITROS Immunodiagnostic Products Anti-HAV Total Reagent Pack and the VITROS Immunodiagnostic Products Anti-HAV Total Calibrator on the VITROS ECi/ECiQ or VITROS 3600 Immunodiagnostic System.
A competitive immunoassay technique is used, which involves pre-incubation of anti-HAV in the sample with HAV antigen in the assay reagent, followed by incubation with a conjugate reagent that contains biotinylated mouse monoclonal anti-HAV antibody and horseradish peroxidase (HRP)-labeled mouse monoclonal anti-HAV antibody. The immune complex is captured by streptavidin on the wells. Unbound materials are removed by washing.
The bound HRP conjugate is measured by a luminescent reaction. A reagent containing luminogenic substrates (a luminol derivative and a peracid salt) and an electron transfer agent, is added to the wells. The HRP in the bound conjugate catalyzes the oxidation of the luminol derivative, producing light. The electron transfer agent (a substituted acetanilide) increases the level of light produced and prolongs its emission. The light signals are read by the VITROS ECi/ECiQ or VITROS 3600 Immunodiagnostic System. The binding of HRP is indicative of the absence of anti-HAV antibody.
Refer to the Laboratory Method Files section for detailed laboratory procedure manual(s) of the methods used.
There were no changes to the lab method, lab equipment, or lab site for this component in the NHANES 2013-2014 cycle.
Hepatitis A Antibody (October 2015)
Blood specimens are processed, stored, and shipped to the Division of Viral Hepatitis, National Center for HIV/AIDS, 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 Procedures Manual (LPM). Vials are stored under appropriate frozen (–30°C) conditions until they are 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 Act 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 quality assurance evaluation during unscheduled visits to evaluate both the quality of the laboratory work and the quality-control 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.
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.
Progress reports containing any problems encountered during shipping or receipt of specimens, summary statistics for each control pool, QC graphs, instrument calibration, reagents, and any special considerations are submitted to NCHS quarterly. The reports are reviewed for trends or shifts in the data. The laboratories are required to explain any identified areas of concern.
All QC procedures recommended by the manufacturers were followed. Reported results for all assays meet the Division of Viral Hepatitis, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention’s quality control and quality assurance performance criteria for accuracy and precision.
The data were reviewed. Incomplete data or improbable values were sent to the performing laboratory for confirmation.
Refer to the 2013 - 2014 Laboratory Data Overview for general information on NHANES laboratory data.
Demographic and Other Related Variables
The analysis of NHANES laboratory data must be conducted using the appropriate survey design and demographic variables. The NHANES 2013-2014 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.
The Fasting Questionnaire File includes auxiliary information such as fasting status, the time of venipuncture, and the conditions precluding venipuncture.
This laboratory data file can be linked to the other NHANES data files using the unique survey participant identifier (i.e., SEQN).
The assay used in this study cannot differentiate between natural infection and vaccination; therefore, seropositivity for anti-HAV reflects either natural or vaccine-induced immunity.
Since this data is reported as qualitative data the use of lower limits of detection (LLODs) isn’t applicable.
Exam sample weights should be used for analyses. 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.
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