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.
Examined male participants aged 14-59 years were eligible. This
data file includes only examined participants aged 14-17 years with limited
access. See Analytic Notes for information on participants aged 18-59 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
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
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
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.
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.
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.
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
Data Processing and Editing
were reviewed. Incomplete data or improbable values were sent to the performing
laboratory for confirmation.
Refer to the 2015-2016 Laboratory Data
for general information on NHANES laboratory data. 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.
MEC exam sample weights should be used for
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).
PCR Assay Summary Variable
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.
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.
Since this data is reported as qualitative
data the use of lower LLODs is not applicable.
The HPV DNA data for youth aged 14–17
years are only available through the NCHS
Research Data Center (RDC).