Table of Contents

Component Description

Human papillomavirus (HPV) infection is one of the most common sexually transmitted infections in the United States. 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 age 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 18-59 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, 89, and IS39) 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.

Refer to the Laboratory Method Files section for a detailed description of the laboratory methods used.

Laboratory Method Files

HPV Penile Swab Linear Array Laboratory Procedure Manual (November 2019)

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 were stored under appropriate refrigerated (2-8°C) conditions until they were shipped to the National Center for Emerging and Zoonotic Infectious Diseases 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. 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 2015-2016 Laboratory Data Overview for general information on NHANES laboratory data.

Please refer to the NHANES Analytic Guidelines and the on-line NHANES Tutorial for details on the use of sample weights and analytic issues.

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 2015-2016 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 β-globin is not present in the sample (both LBDRHP and LBDRLP are negative) and an 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 β-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 707 707
2 Negative 910 1617
3 Inadequate 163 1780
. Missing 82 1862

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 1562 1562
2 Negative 55 1617
3 Inadequate 0 1617
. Missing 245 1862

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 1220 1220
2 Negative 397 1617
3 Inadequate 0 1617
. Missing 245 1862

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 47 47
2 Negative 1570 1617
3 Inadequate 163 1780
. Missing 82 1862

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 7 7
2 Negative 1610 1617
3 Inadequate 163 1780
. Missing 82 1862

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 50 50
2 Negative 1567 1617
3 Inadequate 163 1780
. Missing 82 1862

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 23 23
2 Negative 1594 1617
3 Inadequate 163 1780
. Missing 82 1862

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 1614 1617
3 Inadequate 163 1780
. Missing 82 1862

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 24 24
2 Negative 1593 1617
3 Inadequate 163 1780
. Missing 82 1862

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 2 2
2 Negative 1615 1617
3 Inadequate 163 1780
. Missing 82 1862

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 31 31
2 Negative 1586 1617
3 Inadequate 163 1780
. Missing 82 1862

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 43 43
2 Negative 1574 1617
3 Inadequate 163 1780
. Missing 82 1862

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 22 22
2 Negative 1595 1617
3 Inadequate 163 1780
. Missing 82 1862

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 30 30
2 Negative 1587 1617
3 Inadequate 163 1780
. Missing 82 1862

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 33 33
2 Negative 1584 1617
3 Inadequate 163 1780
. Missing 82 1862

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 95 95
2 Negative 1522 1617
3 Inadequate 163 1780
. Missing 82 1862

LBDR52 - HPV type 52

Variable Name:
LBDR52
SAS Label:
HPV type 52
English Text:
HPV type 52
Target:
Males only 18 YEARS - 59 YEARS
Code or Value Value Description Count Cumulative Skip to Item
1 Positive 66 66
2 Negative 1551 1617
3 Inadequate 163 1780
. Missing 82 1862

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 86 86
2 Negative 1531 1617
3 Inadequate 163 1780
. Missing 82 1862

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 56 56
2 Negative 1561 1617
3 Inadequate 163 1780
. Missing 82 1862

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 16 16
2 Negative 1601 1617
3 Inadequate 163 1780
. Missing 82 1862

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 24 24
2 Negative 1593 1617
3 Inadequate 163 1780
. Missing 82 1862

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 62 62
2 Negative 1555 1617
3 Inadequate 163 1780
. Missing 82 1862

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 66 66
2 Negative 1551 1617
3 Inadequate 163 1780
. Missing 82 1862

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 87 87
2 Negative 1530 1617
3 Inadequate 163 1780
. Missing 82 1862

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 0 0
2 Negative 1617 1617
3 Inadequate 163 1780
. Missing 82 1862

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 52 52
2 Negative 1565 1617
3 Inadequate 163 1780
. Missing 82 1862

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 7 7
2 Negative 1610 1617
3 Inadequate 163 1780
. Missing 82 1862

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 29 29
2 Negative 1588 1617
3 Inadequate 163 1780
. Missing 82 1862

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 73 73
2 Negative 1544 1617
3 Inadequate 163 1780
. Missing 82 1862

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 4 4
2 Negative 1613 1617
3 Inadequate 163 1780
. Missing 82 1862

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 34 34
2 Negative 1583 1617
3 Inadequate 163 1780
. Missing 82 1862

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 13 13
2 Negative 1604 1617
3 Inadequate 163 1780
. Missing 82 1862

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 22 22
2 Negative 1595 1617
3 Inadequate 163 1780
. Missing 82 1862

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 25 25
2 Negative 1592 1617
3 Inadequate 163 1780
. Missing 82 1862

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 27 27
2 Negative 1590 1617
3 Inadequate 163 1780
. Missing 82 1862

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 13 13
2 Negative 1604 1617
3 Inadequate 163 1780
. Missing 82 1862

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 55 55
2 Negative 1562 1617
3 Inadequate 163 1780
. Missing 82 1862

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 110 110
2 Negative 1507 1617
3 Inadequate 163 1780
. Missing 82 1862

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 75 75
2 Negative 1542 1617
3 Inadequate 163 1780
. Missing 82 1862

LBDRPI - HPV type IS39

Variable Name:
LBDRPI
SAS Label:
HPV type IS39
English Text:
HPV type IS39
Target:
Males only 18 YEARS - 59 YEARS
Code or Value Value Description Count Cumulative Skip to Item
1 Positive 4 4
2 Negative 1613 1617
3 Inadequate 163 1780
. Missing 82 1862