Table of Contents

Component Description

The human papillomavirus (HPV) in oral rinse estimates the prevalence and determinants of oral HPV infection in the United States population. Oral HPV infection is newly appreciated as a strong risk factor for a distinct type of oropharyngeal squamous cell carcinoma that is rising in incidences in the United States. It has been estimated that oral HPV16 infection confers an approximate 15-fold increase in risk for oropharyngeal cancer. Despite these strong risks, little is known about the epidemiology of oral HPV infection. No population-based surveys of oral HPV infection, type distribution and determinants, have been performed in any population worldwide.

Eligible Sample

Examined participants, aged 14-69 years, were tested. The public-use data file includes data for persons 18-69 years of age. Please see Analytic Notes about the release of data for adolescents 14-17 years of age.

Description of Laboratory Methodology

Samples will be centrifuged at 4,000 x g for 10 minutes at 4°C; the pellet will be resuspended in 1 ml of Puregene cell lysis solution and incubated at 37°C for 15 min followed by DNase-free RNase a (5µg/ml) digestion for 30 min at 37°C. Proteinase K (20 mg/ml) digestion will be performed overnight at 55°C followed by heat inactivation for 10 min at 95°C. Protein precipitation solution (340 µL) will be added and sample will be further purified according to the Puregene DNA purification kit protocol.

Purified DNA will be analyzed for 37 types of HPV by means of a multiplex polymerase-chain-reaction (PCR) assay targeted to the conserved L1 region of the viral genome, using PGYM09/11 primer pools and primers for ß-globin (33). PCR products will be denatured in 0.13 N NaOH and hybridized to an immobilized HPV probe array (Roche Diagnostics) using an extended line-blot assay for genotyping of 37 HPV types, including HPV-6, -11, -16, -18, -26, -31, -33, -35, -39, -40, -42, -45, -51, -52, -53, -54, -55, -56, -57, -58, -59, -61, -62, -64, -66, -67, -68, -69, -70, -71, -72, -73, -81, -82 (MM4 and IS39 subtypes), -83, -84 and -89, and ß-globin (Roche Molecular Systems, Inc., Alameda, CA). Positive controls, consisting of 10 and 100 HPV-16 (SiHa) or HPV-18 (C4–2)-positive cells diluted in a background of HPV-negative cells (K562), and a negative control (K562 cells), in addition to the manufacturer’s controls, are included in each experiment. Samples positive for ß-globin will be considered of sufficient quality for analysis. The HPV type will be reported for positive samples.

Refer to NHANES 2013-2014 Lab Methods for HPV in oral rinse for detailed description of the laboratory method used.

There were no changes to equipment, lab method, or lab site for this component for the 2013-2014 cycle.

Laboratory Method Files

Laboratory Quality Assurance and Monitoring

Oral rinse specimens were processed, stored and shipped to the Ohio State University Gillison Laboratory, Columbus, Ohio.

Detailed instructions on specimen collection and processing are discussed in the NHANES Laboratory Procedures Manual (LPM).  Vials are stored under appropriate frozen (–30°C) conditions until they are shipped to Ohio State University for testing.

The NHANES quality assurance and quality control (QA/QC) protocols meet the 1988 Clinical Laboratory Improvement Act 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 person is observed for equipment operation, specimen collection and preparation; testing procedures and constructive feedback are given to each staff. Formal retraining sessions are conducted annually to ensure that required skill levels were 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 2.0% of all specimens.

Progress reports containing any problems encountered during shipping or receipt of specimens, summary statistics for each control pool, QC graphs, instrument calibration, reagents, and any special considerations are submitted to NCHS quarterly. The reports are reviewed for trends or shifts in the data. The laboratories are required to explain any identified areas of concern.

All QC procedures recommended by the manufacturers were followed. Reported results for all assays meet the Division of Laboratory Sciences’ quality control and quality assurance performance criteria for accuracy and precision.

Analytic Notes

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

Demographic and Other Related Variables

The analysis of NHANES 2013 - 2014 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. 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 public release data file includes Oral HPV data for participants aged 18–69. Data for youth aged 14–17 years are available through the NCHS Research Data Center (RDC).

Detection Limits

Since this data is reported as qualitative data the use of lower LLODs isn’t applicable.

Exam sample weights should be used for analyses. 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.

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 14 YEARS - 17 YEARS

ORXGH - HPV High Globulin Band result

Variable Name:
ORXGH
SAS Label:
HPV High Globulin Band result
English Text:
HPV High Globulin Band result
Target:
Both males and females 14 YEARS - 17 YEARS
Code or Value Value Description Count Cumulative Skip to Item
1 Positive 684 684
2 Negative 0 684
3 Not evaluated 24 708
. Missing 0 708

ORXGL - HPV Low Globulin Band result

Variable Name:
ORXGL
SAS Label:
HPV Low Globulin Band result
English Text:
HPV Low Globulin Band result
Target:
Both males and females 14 YEARS - 17 YEARS
Code or Value Value Description Count Cumulative Skip to Item
1 Positive 684 684
2 Negative 0 684
3 Not evaluated 24 708
. Missing 0 708

ORXH06 - HPV Type 6

Variable Name:
ORXH06
SAS Label:
HPV Type 6
English Text:
HPV Type 6
Target:
Both males and females 14 YEARS - 17 YEARS
Code or Value Value Description Count Cumulative Skip to Item
1 Positive 1 1
2 Negative 683 684
3 Not evaluated 24 708
. Missing 0 708

ORXH11 - HPV Type 11

Variable Name:
ORXH11
SAS Label:
HPV Type 11
English Text:
HPV Type 11
Target:
Both males and females 14 YEARS - 17 YEARS
Code or Value Value Description Count Cumulative Skip to Item
1 Positive 0 0
2 Negative 684 684
3 Not evaluated 24 708
. Missing 0 708

ORXH16 - HPV Type 16

Variable Name:
ORXH16
SAS Label:
HPV Type 16
English Text:
HPV Type 16
Target:
Both males and females 14 YEARS - 17 YEARS
Code or Value Value Description Count Cumulative Skip to Item
1 Positive 1 1
2 Negative 683 684
3 Not evaluated 24 708
. Missing 0 708

ORXH18 - HPV Type 18

Variable Name:
ORXH18
SAS Label:
HPV Type 18
English Text:
HPV Type 18
Target:
Both males and females 14 YEARS - 17 YEARS
Code or Value Value Description Count Cumulative Skip to Item
1 Positive 0 0
2 Negative 684 684
3 Not evaluated 24 708
. Missing 0 708

ORXH26 - HPV Type 26

Variable Name:
ORXH26
SAS Label:
HPV Type 26
English Text:
HPV Type 26
Target:
Both males and females 14 YEARS - 17 YEARS
Code or Value Value Description Count Cumulative Skip to Item
1 Positive 0 0
2 Negative 684 684
3 Not evaluated 24 708
. Missing 0 708

ORXH31 - HPV Type 31

Variable Name:
ORXH31
SAS Label:
HPV Type 31
English Text:
HPV Type 31
Target:
Both males and females 14 YEARS - 17 YEARS
Code or Value Value Description Count Cumulative Skip to Item
1 Positive 0 0
2 Negative 684 684
3 Not evaluated 24 708
. Missing 0 708

ORXH33 - HPV Type 33

Variable Name:
ORXH33
SAS Label:
HPV Type 33
English Text:
HPV Type 33
Target:
Both males and females 14 YEARS - 17 YEARS
Code or Value Value Description Count Cumulative Skip to Item
1 Positive 0 0
2 Negative 684 684
3 Not evaluated 24 708
. Missing 0 708

ORXH35 - HPV Type 35

Variable Name:
ORXH35
SAS Label:
HPV Type 35
English Text:
HPV Type 35
Target:
Both males and females 14 YEARS - 17 YEARS
Code or Value Value Description Count Cumulative Skip to Item
1 Positive 0 0
2 Negative 684 684
3 Not evaluated 24 708
. Missing 0 708

ORXH39 - HPV Type 39

Variable Name:
ORXH39
SAS Label:
HPV Type 39
English Text:
HPV Type 39
Target:
Both males and females 14 YEARS - 17 YEARS
Code or Value Value Description Count Cumulative Skip to Item
1 Positive 0 0
2 Negative 684 684
3 Not evaluated 24 708
. Missing 0 708

ORXH40 - HPV Type 40

Variable Name:
ORXH40
SAS Label:
HPV Type 40
English Text:
HPV Type 40
Target:
Both males and females 14 YEARS - 17 YEARS
Code or Value Value Description Count Cumulative Skip to Item
1 Positive 0 0
2 Negative 684 684
3 Not evaluated 24 708
. Missing 0 708

ORXH42 - HPV Type 42

Variable Name:
ORXH42
SAS Label:
HPV Type 42
English Text:
HPV Type 42
Target:
Both males and females 14 YEARS - 17 YEARS
Code or Value Value Description Count Cumulative Skip to Item
1 Positive 0 0
2 Negative 684 684
3 Not evaluated 24 708
. Missing 0 708

ORXH45 - HPV Type 45

Variable Name:
ORXH45
SAS Label:
HPV Type 45
English Text:
HPV Type 45
Target:
Both males and females 14 YEARS - 17 YEARS
Code or Value Value Description Count Cumulative Skip to Item
1 Positive 0 0
2 Negative 684 684
3 Not evaluated 24 708
. Missing 0 708

ORXH51 - HPV Type 51

Variable Name:
ORXH51
SAS Label:
HPV Type 51
English Text:
HPV Type 51
Target:
Both males and females 14 YEARS - 17 YEARS
Code or Value Value Description Count Cumulative Skip to Item
1 Positive 0 0
2 Negative 684 684
3 Not evaluated 24 708
. Missing 0 708

ORXH52 - HPV Type 52

Variable Name:
ORXH52
SAS Label:
HPV Type 52
English Text:
HPV Type 52
Target:
Both males and females 14 YEARS - 17 YEARS
Code or Value Value Description Count Cumulative Skip to Item
1 Positive 0 0
2 Negative 684 684
3 Not evaluated 24 708
. Missing 0 708

ORXH53 - HPV Type 53

Variable Name:
ORXH53
SAS Label:
HPV Type 53
English Text:
HPV Type 53
Target:
Both males and females 14 YEARS - 17 YEARS
Code or Value Value Description Count Cumulative Skip to Item
1 Positive 1 1
2 Negative 683 684
3 Not evaluated 24 708
. Missing 0 708

ORXH54 - HPV Type 54

Variable Name:
ORXH54
SAS Label:
HPV Type 54
English Text:
HPV Type 54
Target:
Both males and females 14 YEARS - 17 YEARS
Code or Value Value Description Count Cumulative Skip to Item
1 Positive 0 0
2 Negative 684 684
3 Not evaluated 24 708
. Missing 0 708

ORXH55 - HPV Type 55

Variable Name:
ORXH55
SAS Label:
HPV Type 55
English Text:
HPV Type 55
Target:
Both males and females 14 YEARS - 17 YEARS
Code or Value Value Description Count Cumulative Skip to Item
1 Positive 2 2
2 Negative 682 684
3 Not evaluated 24 708
. Missing 0 708

ORXH56 - HPV Type 56

Variable Name:
ORXH56
SAS Label:
HPV Type 56
English Text:
HPV Type 56
Target:
Both males and females 14 YEARS - 17 YEARS
Code or Value Value Description Count Cumulative Skip to Item
1 Positive 1 1
2 Negative 683 684
3 Not evaluated 24 708
. Missing 0 708

ORXH58 - HPV Type 58

Variable Name:
ORXH58
SAS Label:
HPV Type 58
English Text:
HPV Type 58
Target:
Both males and females 14 YEARS - 17 YEARS
Code or Value Value Description Count Cumulative Skip to Item
1 Positive 1 1
2 Negative 683 684
3 Not evaluated 24 708
. Missing 0 708

ORXH59 - HPV Type 59

Variable Name:
ORXH59
SAS Label:
HPV Type 59
English Text:
HPV Type 59
Target:
Both males and females 14 YEARS - 17 YEARS
Code or Value Value Description Count Cumulative Skip to Item
1 Positive 3 3
2 Negative 681 684
3 Not evaluated 24 708
. Missing 0 708

ORXH61 - HPV Type 61

Variable Name:
ORXH61
SAS Label:
HPV Type 61
English Text:
HPV Type 61
Target:
Both males and females 14 YEARS - 17 YEARS
Code or Value Value Description Count Cumulative Skip to Item
1 Positive 1 1
2 Negative 683 684
3 Not evaluated 24 708
. Missing 0 708

ORXH62 - HPV Type 62

Variable Name:
ORXH62
SAS Label:
HPV Type 62
English Text:
HPV Type 62
Target:
Both males and females 14 YEARS - 17 YEARS
Code or Value Value Description Count Cumulative Skip to Item
1 Positive 1 1
2 Negative 683 684
3 Not evaluated 24 708
. Missing 0 708

ORXH64 - HPV Type 64

Variable Name:
ORXH64
SAS Label:
HPV Type 64
English Text:
HPV Type 64
Target:
Both males and females 14 YEARS - 17 YEARS
Code or Value Value Description Count Cumulative Skip to Item
1 Positive 0 0
2 Negative 684 684
3 Not evaluated 24 708
. Missing 0 708

ORXH66 - HPV Type 66

Variable Name:
ORXH66
SAS Label:
HPV Type 66
English Text:
HPV Type 66
Target:
Both males and females 14 YEARS - 17 YEARS
Code or Value Value Description Count Cumulative Skip to Item
1 Positive 3 3
2 Negative 681 684
3 Not evaluated 24 708
. Missing 0 708

ORXH67 - HPV Type 67

Variable Name:
ORXH67
SAS Label:
HPV Type 67
English Text:
HPV Type 67
Target:
Both males and females 14 YEARS - 17 YEARS
Code or Value Value Description Count Cumulative Skip to Item
1 Positive 0 0
2 Negative 684 684
3 Not evaluated 24 708
. Missing 0 708

ORXH68 - HPV Type 68

Variable Name:
ORXH68
SAS Label:
HPV Type 68
English Text:
HPV Type 68
Target:
Both males and females 14 YEARS - 17 YEARS
Code or Value Value Description Count Cumulative Skip to Item
1 Positive 0 0
2 Negative 684 684
3 Not evaluated 24 708
. Missing 0 708

ORXH69 - HPV Type 69

Variable Name:
ORXH69
SAS Label:
HPV Type 69
English Text:
HPV Type 69
Target:
Both males and females 14 YEARS - 17 YEARS
Code or Value Value Description Count Cumulative Skip to Item
1 Positive 0 0
2 Negative 684 684
3 Not evaluated 24 708
. Missing 0 708

ORXH70 - HPV Type 70

Variable Name:
ORXH70
SAS Label:
HPV Type 70
English Text:
HPV Type 70
Target:
Both males and females 14 YEARS - 17 YEARS
Code or Value Value Description Count Cumulative Skip to Item
1 Positive 0 0
2 Negative 684 684
3 Not evaluated 24 708
. Missing 0 708

ORXH71 - HPV Type 71

Variable Name:
ORXH71
SAS Label:
HPV Type 71
English Text:
HPV Type 71
Target:
Both males and females 14 YEARS - 17 YEARS
Code or Value Value Description Count Cumulative Skip to Item
1 Positive 0 0
2 Negative 684 684
3 Not evaluated 24 708
. Missing 0 708

ORXH72 - HPV Type 72

Variable Name:
ORXH72
SAS Label:
HPV Type 72
English Text:
HPV Type 72
Target:
Both males and females 14 YEARS - 17 YEARS
Code or Value Value Description Count Cumulative Skip to Item
1 Positive 2 2
2 Negative 682 684
3 Not evaluated 24 708
. Missing 0 708

ORXH73 - HPV Type 73

Variable Name:
ORXH73
SAS Label:
HPV Type 73
English Text:
HPV Type 73
Target:
Both males and females 14 YEARS - 17 YEARS
Code or Value Value Description Count Cumulative Skip to Item
1 Positive 1 1
2 Negative 683 684
3 Not evaluated 24 708
. Missing 0 708

ORXH81 - HPV Type 81

Variable Name:
ORXH81
SAS Label:
HPV Type 81
English Text:
HPV Type 81
Target:
Both males and females 14 YEARS - 17 YEARS
Code or Value Value Description Count Cumulative Skip to Item
1 Positive 0 0
2 Negative 684 684
3 Not evaluated 24 708
. Missing 0 708

ORXH82 - HPV Type 82

Variable Name:
ORXH82
SAS Label:
HPV Type 82
English Text:
HPV Type 82
Target:
Both males and females 14 YEARS - 17 YEARS
Code or Value Value Description Count Cumulative Skip to Item
1 Positive 0 0
2 Negative 684 684
3 Not evaluated 24 708
. Missing 0 708

ORXH83 - HPV Type 83

Variable Name:
ORXH83
SAS Label:
HPV Type 83
English Text:
HPV Type 83
Target:
Both males and females 14 YEARS - 17 YEARS
Code or Value Value Description Count Cumulative Skip to Item
1 Positive 0 0
2 Negative 684 684
3 Not evaluated 24 708
. Missing 0 708

ORXH84 - HPV Type 84

Variable Name:
ORXH84
SAS Label:
HPV Type 84
English Text:
HPV Type 84
Target:
Both males and females 14 YEARS - 17 YEARS
Code or Value Value Description Count Cumulative Skip to Item
1 Positive 2 2
2 Negative 682 684
3 Not evaluated 24 708
. Missing 0 708

ORXHPC - HPV CP 6108

Variable Name:
ORXHPC
SAS Label:
HPV CP 6108
English Text:
HPV CP 6108
Target:
Both males and females 14 YEARS - 17 YEARS
Code or Value Value Description Count Cumulative Skip to Item
1 Positive 0 0
2 Negative 684 684
3 Not evaluated 24 708
. Missing 0 708

ORXHPI - HPV Type IS39

Variable Name:
ORXHPI
SAS Label:
HPV Type IS39
English Text:
HPV Type IS39
Target:
Both males and females 14 YEARS - 17 YEARS
Code or Value Value Description Count Cumulative Skip to Item
1 Positive 0 0
2 Negative 684 684
3 Not evaluated 24 708
. Missing 0 708

ORXHPV - Oral HPV Result

Variable Name:
ORXHPV
SAS Label:
Oral HPV Result
English Text:
Oral HPV Result
Target:
Both males and females 14 YEARS - 17 YEARS
Code or Value Value Description Count Cumulative Skip to Item
1 Positive 15 15
2 Negative 669 684
3 Not evaluated 24 708
. Missing 0 708