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 hepatitis B virus (HBV) and hepatitis A virus (HAV) in the United States. Recommendations have also been developed for the prevention and control of 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. Testing for hepatitis B surface antibody contributes information important to distinguish immunity from vaccination among persons who lack antibodies to hepatitis B core. 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.
All participants aged 2 years or older are eligible to be tested.
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. Detailed instructions on specimen collection and processing can be found on the NHANES website.
The VITROS Anti-HBs Quantitative assay is performed using the VITROS Anti-HBs Quantitative Reagent Pack and VITROS Immunodiagnostic Products Anti-HBs Calibrators on the VITROS ECi/ECiQ or VITROS 3600 Immunodiagnostic System.
An immunometric technique is used. This involves the reaction of anti-HBs in the sample with HBsAg (ad and ay subtypes) coated onto the wells. A horseradish peroxidase (HRP)-labeled HBsAg conjugate (ad and ay subtypes) then complexes with the bound anti-HBs forming an “antigen sandwich.” Unbound materials are removed by washing.
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 increases the level and duration of the light produced. The light signals are read by the VITROS ECi/ECiQ or VITROS 3600 Immunodiagnostic System. The amount of HRP conjugate bound is directly proportional to the concentration of anti-HBs present.
There were no changes (from the previous 2 years of NHANES) to the lab methods.
The analytical methods are described in the Description of Laboratory Methodology section above.
The NHANES quality control and quality assurance protocols (QA/QC) meet the 1988 Clinical Laboratory Improvement Act mandates. Detailed QA/QC instructions are discussed in the NHANES Laboratory/Medical Technologists Procedures Manual (LPM).
A detailed description of the quality assurance and quality control procedures can be found on the NHANES website.
Refer to the 2011-2012 Laboratory Data Overview for general information on NHANES laboratory data.
The analysis of NHANES 2011-2012 laboratory data must be conducted using the appropriate survey design and demographic variables. The NHANES 2011-2012 Demographics File contains demographic data, health indicators, and other related information collected during household interviews as well as the sample weight variables. The Fasting Questionnaire File includes auxiliary information such as fasting status, the time of venipuncture, and the conditions precluding venipuncture. The demographics and fasting questionnaire files may be linked to the laboratory data file using the unique survey participant identifier (i.e., SEQN).
The age range and constraints for Hepatitis B testing are as follows: The anti-HBs test is performed on all participants aged 2 years or older.
Exam sample weights should be used for analyses.
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