Table of Contents

Component Description

Human papillomavirus (HPV) infection is the most common sexually transmitted infection in the United States. Cervical infection with certain types of HPV is causally associated with cervical cancer in women. No national surveillance system exists to measure the full burden of HPV infection, and no reliable national population estimate of HPV exists. NHANES offers a unique opportunity to assess the prevalence of HPV infection in the general population.

Reducing the prevalence of HPV infection is a Developmental Healthy People 2010 objective: “Reducing the number of new HPV cases can help minimize the overall number of cases of high risk subtypes associated with cervical cancer in females ...” Two HPV vaccines are licensed, and knowledge of the national prevalence of HPV infection is critical for planning vaccination strategies and monitoring the impact of vaccination in the United States.

Eligible Sample

All participants aged 18 to 59 years.

Description of Laboratory Methodology

Competitive Luminex Immunoassay of Antibodies to Neutralizing Epitopes on HPV 6, 11, 16 and 18 L1-Virus-Like Particles (VLPs)

This method uses the Luminex platform to simultaneously assay antibodies to HPV 6, 11, 16 and 18. Type-specific antibodies of any Ig class are detected by competing with and blocking the binding of fluorescently tagged neutralizing monoclonal antibody from VLP-coated microspheres.

Data Processing and Editing

Blood specimens were processed, stored and shipped to Atlanta, Ga. for analysis. Detailed specimen collection and processing instructions are discussed in the NHANES LPM. Read the LABDOC file for detailed data processing and editing protocols. The analytical methods are described in the Description of the Laboratory Methodology section. The Competitive Luminex Immunoassay was conducted at Pharmaceutical Product Development (PPD) Inc. using the protocol established by Merck for vaccine clinical trials.

Analytic Notes

The analysis of NHANES laboratory data must be conducted with the key survey design and basic demographic variables. The Demographic file contains: Status Variables providing core information on the survey participant including examination status, Recoded Demographic Variables including age, gender, race etc., and Interview and Examination Sample Weight Variables and Survey Design Variables. The recommended procedure for variance estimation requires use of stratum and PSU variables (SDMVSTRA and SDMVPSU, respectively), which are included in the demographic data file for each data release. The Questionnaire Data Files contain socio-economic data, health indicators, and other related information collected during household interviews. The Phlebotomy Examination file includes auxiliary information on duration of fasting, the time of day of the venipuncture, and the conditions precluding venipuncture. The Demographic, Questionnaire and Phlebotomy Examination files may be linked to the laboratory data file using the unique survey participant identifier SEQN.

Serum

Competitive Luminex Immunoassay for HPV 6, 11, 16, 18 established the serostatus cut-off values for a positive result for each HPV type in the assay as listed below. A final titer below this value is negative and a value equal or above is considered positive.

Sero-Status Cutoff(mMU/mL): HPV6=20, HPV11=16, HPV16=20, HPV18=24.

References

Codebook and Frequencies

SEQN - Respondent sequence number

Variable Name:
SEQN
SAS Label:
Respondent sequence number
English Text:
Respondent sequence number.
Target:
Both males and females 18 YEARS - 59 YEARS

LBX06 - HPV 06 result

Variable Name:
LBX06
SAS Label:
HPV 06 result
English Text:
HPV 06 result
Target:
Both males and females 18 YEARS - 59 YEARS
Code or Value Value Description Count Cumulative Skip to Item
1 Positive 695 695
2 Negative 2935 3630
. Missing 320 3950

LBX11 - HPV 11 result

Variable Name:
LBX11
SAS Label:
HPV 11 result
English Text:
HPV 11 result
Target:
Both males and females 18 YEARS - 59 YEARS
Code or Value Value Description Count Cumulative Skip to Item
1 Positive 207 207
2 Negative 3423 3630
. Missing 320 3950

LBX16 - HPV 16 result

Variable Name:
LBX16
SAS Label:
HPV 16 result
English Text:
HPV 16 result
Target:
Both males and females 18 YEARS - 59 YEARS
Code or Value Value Description Count Cumulative Skip to Item
1 Positive 461 461
2 Negative 3169 3630
. Missing 320 3950

LBX18 - HPV 18 result

Variable Name:
LBX18
SAS Label:
HPV 18 result
English Text:
HPV 18 result
Target:
Both males and females 18 YEARS - 59 YEARS
Code or Value Value Description Count Cumulative Skip to Item
1 Positive 212 212
2 Negative 3418 3630
. Missing 320 3950