Table of Contents

Component Description

Human papillomavirus (HPV) infection is one of the most common sexually transmitted infections in the United States. There is no national surveillance system that currently exists to measure the full burden of HPV infection. Although HPV can infect men and women, less is known about HPV prevalence in men. In 2011, routine HPV vaccination was recommended by the Advisory Committee on Immunization Practices (ACIP) for males aged 11-12 years. Vaccination was also recommended for men through aged 21 years if not previously vaccinated. Information on the national prevalence of HPV infection is important for planning vaccination strategies and monitoring the impact of vaccination in the United States.

Eligible Sample

Examined male participants aged 14-59 years were eligible. This public data file only includes examined participants aged 18 to 59 years. See Analytic Notes for information on participants aged 14-17 years.

Description of Laboratory Methodology

DNA from the self-collected penile swab is extracted for use in the test below: Roche Linear Array.

Roche Linear Array Assay

This assay uses Roche Linear Array HPV Genotyping test that is based on HPV L1 consensus polymerase chain reaction (PCR) with biotinylated PGMY09/11 primer sets. It also includes biotinylated β-globin primers as an internal control for sample amplification. The primer mix amplifies essentially all HPV types found in the genital tract along with the human β-globin gene. After amplification the samples are typed by hybridization to the typing strips followed by colorimetric detection. The strip is a linear array of probes specific for 37 HPV types (6, 11, 16, 18, 26, 31, 33, 35, 39, 40, 42, 45, 51, 52, 53, 54, 55, 56, 58, 59, 61, 62, 64, 66, 67, 68, 69, 70, 71, 72, 73, 81, 82, 83, 84, and 89) and for the positive β-globin control as well. Types are read by comparing the reaction pattern to the typing template. Samples that are negative for HPV and the β-globin control indicate lack of a suitable sample and are considered inadequate for interpretation.

Please refer to the Laboratory Method Files section for detailed laboratory procedure manual(s) of the methods used.

Laboratory Method Files

Laboratory Quality Assurance and Monitoring

Penile swab specimens are processed, stored and shipped to the Division of High-Consequence Pathogens and Pathology, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention (CDC), 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 refrigerated (2-8°C) conditions until they are shipped to the CDC for testing.

The NHANES quality control and quality assurance protocols (QA/QC) meet the 1988 Clinical Laboratory Improvement Act (CLIA) 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 are 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.

Progress reports containing any problems encountered during shipping or receipt of specimens are submitted to NCHS. The reports are reviewed and the laboratories are required to explain any identified areas of concern.

The HPV PCR tests are research tests. The HPV laboratory followed strict research QC/QA and has been CLIA certified since August 2008. Detailed quality control and quality assurance instructions are discussed in the NHANES Laboratory Procedures Manual (LPM). The analytical methods are described in the Description of the Laboratory Methodology section.

Data Processing and Editing

The data were reviewed. Incomplete data or improbable values were sent to the performing laboratory for confirmation.

Analytic Notes

Refer to the 2013-2014 Laboratory Data Overview for general information on NHANES Laboratory data.

Sample Weights
MEC exam sample weights should be used for analyses.

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 weight variables. This laboratory data file can be linked to the other NHANES data files using the unique survey participant identifier (i.e., SEQN).

HPV PCR Assay Summary Variable
HPV PCR Summary variable (LBDRPCR) indicates the following: if at least one type is positive (LBDRPCR=1); if the sample is negative (LBDRPCR=2); if the sample is inadequate (LBDRPCR=3); or if the sample is missing (LBDRPCR=.).

If Beta globin is not present in the sample (both LBDRHP and LBDRLP are negative) and HPV type is not detected, the sample is coded as inadequate.

If any of the types on the strips (LBDR06-LBDRPI) are positive, the sample is coded as positive. If all of the types on the strip are coded as negative, and beta-globin is detected (either LBDRHP or LBDRLP is positive) the sample is coded as negative.

Variables LBDRHP through LBDRPI are from the RUO Roche Linear Array HPV typing assay, however, LBDR52 also includes information from a type-specific assay for HPV 52. The Linear Array typing strip includes an XR probe that hybridizes with HPV 52 as well as HPV types 33, 35 and 58. Samples that are positive for the XR probe and 33, 35, or 58 require specific testing to confirm the presence of HPV 52.

Detection Limits
Since this data is reported as qualitative data the use of lower LLODs is not applicable.

Data Access
The public release data file includes HPV DNA data for males aged 18-59 years. HPV DNA data for youth aged 14–17 years are available through the NCHS Research Data Center (RDC)

 

References

Codebook and Frequencies

SEQN - Respondent sequence number

Variable Name:
SEQN
SAS Label:
Respondent sequence number
English Text:
Respondent sequence number.
Target:
Males only 18 YEARS - 59 YEARS

LBDRPCR - Roche HPV linear array summary result

Variable Name:
LBDRPCR
SAS Label:
Roche HPV linear array summary result
English Text:
Roche HPV linear array (LA) summary result
Target:
Males only 18 YEARS - 59 YEARS
Code or Value Value Description Count Cumulative Skip to Item
1 Positive 795 795
2 Negative 962 1757
3 Inadequate 111 1868
. Missing 107 1975

LBDRHP - Roche LA high positive globin control

Variable Name:
LBDRHP
SAS Label:
Roche LA high positive globin control
English Text:
Roche LA high positive globin control
Target:
Males only 18 YEARS - 59 YEARS
Code or Value Value Description Count Cumulative Skip to Item
1 Positive 1710 1710
2 Negative 47 1757
. Missing 218 1975

LBDRLP - Roche LA low positive globin control

Variable Name:
LBDRLP
SAS Label:
Roche LA low positive globin control
English Text:
Roche LA low positive globin control
Target:
Males only 18 YEARS - 59 YEARS
Code or Value Value Description Count Cumulative Skip to Item
1 Positive 1304 1304
2 Negative 453 1757
. Missing 218 1975

LBDR06 - HPV type 6

Variable Name:
LBDR06
SAS Label:
HPV type 6
English Text:
HPV type 6
Target:
Males only 18 YEARS - 59 YEARS
Code or Value Value Description Count Cumulative Skip to Item
1 Positive 48 48
2 Negative 1709 1757
3 Inadequate 111 1868
. Missing 107 1975

LBDR11 - HPV type 11

Variable Name:
LBDR11
SAS Label:
HPV type 11
English Text:
HPV type 11
Target:
Males only 18 YEARS - 59 YEARS
Code or Value Value Description Count Cumulative Skip to Item
1 Positive 5 5
2 Negative 1752 1757
3 Inadequate 111 1868
. Missing 107 1975

LBDR16 - HPV type 16

Variable Name:
LBDR16
SAS Label:
HPV type 16
English Text:
HPV type 16
Target:
Males only 18 YEARS - 59 YEARS
Code or Value Value Description Count Cumulative Skip to Item
1 Positive 73 73
2 Negative 1684 1757
3 Inadequate 111 1868
. Missing 107 1975

LBDR18 - HPV type 18

Variable Name:
LBDR18
SAS Label:
HPV type 18
English Text:
HPV type 18
Target:
Males only 18 YEARS - 59 YEARS
Code or Value Value Description Count Cumulative Skip to Item
1 Positive 35 35
2 Negative 1722 1757
3 Inadequate 111 1868
. Missing 107 1975

LBDR26 - HPV type 26

Variable Name:
LBDR26
SAS Label:
HPV type 26
English Text:
HPV type 26
Target:
Males only 18 YEARS - 59 YEARS
Code or Value Value Description Count Cumulative Skip to Item
1 Positive 3 3
2 Negative 1754 1757
3 Inadequate 111 1868
. Missing 107 1975

LBDR31 - HPV type 31

Variable Name:
LBDR31
SAS Label:
HPV type 31
English Text:
HPV type 31
Target:
Males only 18 YEARS - 59 YEARS
Code or Value Value Description Count Cumulative Skip to Item
1 Positive 27 27
2 Negative 1730 1757
3 Inadequate 111 1868
. Missing 107 1975

LBDR33 - HPV type 33

Variable Name:
LBDR33
SAS Label:
HPV type 33
English Text:
HPV type 33
Target:
Males only 18 YEARS - 59 YEARS
Code or Value Value Description Count Cumulative Skip to Item
1 Positive 20 20
2 Negative 1737 1757
3 Inadequate 111 1868
. Missing 107 1975

LBDR35 - HPV type 35

Variable Name:
LBDR35
SAS Label:
HPV type 35
English Text:
HPV type 35
Target:
Males only 18 YEARS - 59 YEARS
Code or Value Value Description Count Cumulative Skip to Item
1 Positive 40 40
2 Negative 1717 1757
3 Inadequate 111 1868
. Missing 107 1975

LBDR39 - HPV type 39

Variable Name:
LBDR39
SAS Label:
HPV type 39
English Text:
HPV type 39
Target:
Males only 18 YEARS - 59 YEARS
Code or Value Value Description Count Cumulative Skip to Item
1 Positive 57 57
2 Negative 1700 1757
3 Inadequate 111 1868
. Missing 107 1975

LBDR40 - HPV type 40

Variable Name:
LBDR40
SAS Label:
HPV type 40
English Text:
HPV type 40
Target:
Males only 18 YEARS - 59 YEARS
Code or Value Value Description Count Cumulative Skip to Item
1 Positive 21 21
2 Negative 1736 1757
3 Inadequate 111 1868
. Missing 107 1975

LBDR42 - HPV type 42

Variable Name:
LBDR42
SAS Label:
HPV type 42
English Text:
HPV type 42
Target:
Males only 18 YEARS - 59 YEARS
Code or Value Value Description Count Cumulative Skip to Item
1 Positive 51 51
2 Negative 1706 1757
3 Inadequate 111 1868
. Missing 107 1975

LBDR45 - HPV type 45

Variable Name:
LBDR45
SAS Label:
HPV type 45
English Text:
HPV type 45
Target:
Males only 18 YEARS - 59 YEARS
Code or Value Value Description Count Cumulative Skip to Item
1 Positive 38 38
2 Negative 1719 1757
3 Inadequate 111 1868
. Missing 107 1975

LBDR51 - HPV type 51

Variable Name:
LBDR51
SAS Label:
HPV type 51
English Text:
HPV type 51
Target:
Males only 18 YEARS - 59 YEARS
Code or Value Value Description Count Cumulative Skip to Item
1 Positive 97 97
2 Negative 1660 1757
3 Inadequate 111 1868
. Missing 107 1975

LBDR52 - HPV type 52

Variable Name:
LBDR52
SAS Label:
HPV type 52
English Text:
HPV type 51
Target:
Males only 18 YEARS - 59 YEARS
Code or Value Value Description Count Cumulative Skip to Item
1 Positive 54 54
2 Negative 1703 1757
3 Inadequate 111 1868
. Missing 107 1975

LBDR53 - HPV type 53

Variable Name:
LBDR53
SAS Label:
HPV type 53
English Text:
HPV type 53
Target:
Males only 18 YEARS - 59 YEARS
Code or Value Value Description Count Cumulative Skip to Item
1 Positive 95 95
2 Negative 1662 1757
3 Inadequate 111 1868
. Missing 107 1975

LBDR54 - HPV type 54

Variable Name:
LBDR54
SAS Label:
HPV type 54
English Text:
HPV type 54
Target:
Males only 18 YEARS - 59 YEARS
Code or Value Value Description Count Cumulative Skip to Item
1 Positive 68 68
2 Negative 1689 1757
3 Inadequate 111 1868
. Missing 107 1975

LBDR55 - HPV type 55

Variable Name:
LBDR55
SAS Label:
HPV type 55
English Text:
HPV type 55
Target:
Males only 18 YEARS - 59 YEARS
Code or Value Value Description Count Cumulative Skip to Item
1 Positive 53 53
2 Negative 1704 1757
3 Inadequate 111 1868
. Missing 107 1975

LBDR56 - HPV type 56

Variable Name:
LBDR56
SAS Label:
HPV type 56
English Text:
HPV type 56
Target:
Males only 18 YEARS - 59 YEARS
Code or Value Value Description Count Cumulative Skip to Item
1 Positive 24 24
2 Negative 1733 1757
3 Inadequate 111 1868
. Missing 107 1975

LBDR58 - HPV type 58

Variable Name:
LBDR58
SAS Label:
HPV type 58
English Text:
HPV type 58
Target:
Males only 18 YEARS - 59 YEARS
Code or Value Value Description Count Cumulative Skip to Item
1 Positive 22 22
2 Negative 1735 1757
3 Inadequate 111 1868
. Missing 107 1975

LBDR59 - HPV type 59

Variable Name:
LBDR59
SAS Label:
HPV type 59
English Text:
HPV type 59
Target:
Males only 18 YEARS - 59 YEARS
Code or Value Value Description Count Cumulative Skip to Item
1 Positive 69 69
2 Negative 1688 1757
3 Inadequate 111 1868
. Missing 107 1975

LBDR61 - HPV type 61

Variable Name:
LBDR61
SAS Label:
HPV type 61
English Text:
HPV type 61
Target:
Males only 18 YEARS - 59 YEARS
Code or Value Value Description Count Cumulative Skip to Item
1 Positive 88 88
2 Negative 1669 1757
3 Inadequate 111 1868
. Missing 107 1975

LBDR62 - HPV type 62

Variable Name:
LBDR62
SAS Label:
HPV type 62
English Text:
HPV type 62
Target:
Males only 18 YEARS - 59 YEARS
Code or Value Value Description Count Cumulative Skip to Item
1 Positive 130 130
2 Negative 1627 1757
3 Inadequate 111 1868
. Missing 107 1975

LBDR64 - HPV type 64

Variable Name:
LBDR64
SAS Label:
HPV type 64
English Text:
HPV type 64
Target:
Males only 18 YEARS - 59 YEARS
Code or Value Value Description Count Cumulative Skip to Item
1 Positive 1 1
2 Negative 1756 1757
3 Inadequate 111 1868
. Missing 107 1975

LBDR66 - HPV type 66

Variable Name:
LBDR66
SAS Label:
HPV type 66
English Text:
HPV type 66
Target:
Males only 18 YEARS - 59 YEARS
Code or Value Value Description Count Cumulative Skip to Item
1 Positive 85 85
2 Negative 1672 1757
3 Inadequate 111 1868
. Missing 107 1975

LBDR67 - HPV type 67

Variable Name:
LBDR67
SAS Label:
HPV type 67
English Text:
HPV type 67
Target:
Males only 18 YEARS - 59 YEARS
Code or Value Value Description Count Cumulative Skip to Item
1 Positive 13 13
2 Negative 1744 1757
3 Inadequate 111 1868
. Missing 107 1975

LBDR68 - HPV type 68

Variable Name:
LBDR68
SAS Label:
HPV type 68
English Text:
HPV type 68
Target:
Males only 18 YEARS - 59 YEARS
Code or Value Value Description Count Cumulative Skip to Item
1 Positive 25 25
2 Negative 1732 1757
3 Inadequate 111 1868
. Missing 107 1975

LBDR69 - HPV type 69

Variable Name:
LBDR69
SAS Label:
HPV type 69
English Text:
HPV type 69
Target:
Males only 18 YEARS - 59 YEARS
Code or Value Value Description Count Cumulative Skip to Item
1 Positive 2 2
2 Negative 1755 1757
3 Inadequate 111 1868
. Missing 107 1975

LBDR70 - HPV type 70

Variable Name:
LBDR70
SAS Label:
HPV type 70
English Text:
HPV type 70
Target:
Males only 18 YEARS - 59 YEARS
Code or Value Value Description Count Cumulative Skip to Item
1 Positive 36 36
2 Negative 1721 1757
3 Inadequate 111 1868
. Missing 107 1975

LBDR71 - HPV type 71

Variable Name:
LBDR71
SAS Label:
HPV type 71
English Text:
HPV type 71
Target:
Males only 18 YEARS - 59 YEARS
Code or Value Value Description Count Cumulative Skip to Item
1 Positive 14 14
2 Negative 1743 1757
3 Inadequate 111 1868
. Missing 107 1975

LBDR72 - HPV type 72

Variable Name:
LBDR72
SAS Label:
HPV type 72
English Text:
HPV type 72
Target:
Males only 18 YEARS - 59 YEARS
Code or Value Value Description Count Cumulative Skip to Item
1 Positive 33 33
2 Negative 1724 1757
3 Inadequate 111 1868
. Missing 107 1975

LBDR73 - HPV type 73

Variable Name:
LBDR73
SAS Label:
HPV type 73
English Text:
HPV type 73
Target:
Males only 18 YEARS - 59 YEARS
Code or Value Value Description Count Cumulative Skip to Item
1 Positive 32 32
2 Negative 1725 1757
3 Inadequate 111 1868
. Missing 107 1975

LBDR81 - HPV type 81

Variable Name:
LBDR81
SAS Label:
HPV type 81
English Text:
HPV type 81
Target:
Males only 18 YEARS - 59 YEARS
Code or Value Value Description Count Cumulative Skip to Item
1 Positive 45 45
2 Negative 1712 1757
3 Inadequate 111 1868
. Missing 107 1975

LBDR82 - HPV type 82

Variable Name:
LBDR82
SAS Label:
HPV type 82
English Text:
HPV type 82
Target:
Males only 18 YEARS - 59 YEARS
Code or Value Value Description Count Cumulative Skip to Item
1 Positive 21 21
2 Negative 1736 1757
3 Inadequate 111 1868
. Missing 107 1975

LBDR83 - HPV type 83

Variable Name:
LBDR83
SAS Label:
HPV type 83
English Text:
HPV type 83
Target:
Males only 18 YEARS - 59 YEARS
Code or Value Value Description Count Cumulative Skip to Item
1 Positive 68 68
2 Negative 1689 1757
3 Inadequate 111 1868
. Missing 107 1975

LBDR84 - HPV type 84

Variable Name:
LBDR84
SAS Label:
HPV type 84
English Text:
HPV type 84
Target:
Males only 18 YEARS - 59 YEARS
Code or Value Value Description Count Cumulative Skip to Item
1 Positive 128 128
2 Negative 1629 1757
3 Inadequate 111 1868
. Missing 107 1975

LBDR89 - HPV type 89

Variable Name:
LBDR89
SAS Label:
HPV type 89
English Text:
HPV type 89
Target:
Males only 18 YEARS - 59 YEARS
Code or Value Value Description Count Cumulative Skip to Item
1 Positive 89 89
2 Negative 1668 1757
3 Inadequate 111 1868
. Missing 107 1975

LBDRPI - HPV type IS39

Variable Name:
LBDRPI
SAS Label:
HPV type IS39
English Text:
HPV type IS39
Target:
Both males and females 18 YEARS - 59 YEARS
Code or Value Value Description Count Cumulative Skip to Item
1 to 2 Range of Values 1757 1757
. Missing 218 1975