Protocol for Collection of Oral Human Papillomavirus Specimen (ages 14+)

Attachment B.

Protocol for Collection of Oral Human Papillomavirus Specimen (ages 14+)

National Health and Nutrition Examination Survey (NHANES)

Oral Human Papillomavirus Specimen Collection Pilot Study

OMB no. 0920-0237

Expires: 11/30/2009

Notice - Information contained on this form which would permit identification of any individual or establishment has been collected with a guarantee that it will be held in strict confidence, will be used only for purposes stated for this study, and will not be disclosed or released to others without the consent of the individual or establishment in accordance with section 308(d) of the Public Health Service Act (42 USC 242m). Public reporting burden of this collection of information is estimated to average 2.5 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to CDC/ATSDR Reports Clearance Officer; 1600 Clifton Road, MS D-74, Atlanta, GA 30333. ATTN: PRA (0920-0214).

Oral Human Papillomavirus Specimen Collection Protocol:

Eligibility: Participants aged 14 years or older are eligible for this component.

Informed Consent: Informed consent will be obtained. The purpose of the test will be described to the respondent. As with all of NHANES components, the participant may refuse.

Exclusion Criteria: There are no exclusions for the Oral Human Papillomavirus component.

Study Design:

Specimen Collection

The collection will be accomplished with a 30 second oral rinse and gargle with Scope brand mouthwash. Participants age 14 or more years will alternate a series of three, five second rinse and five second gargles with 10 ml of Scope. The Scope is then expectorated into a sterile collection cup and transported to the MEC laboratory and refrigerated at 4^oC.

Laboratory Testing

Testing for 37 types of HPV will be accomplished by means of a multiple polymerase-chain reaction (PCR) assay targeted to the L1 region of the viral genome, using PGMY09/11 L1 primer pools and primers for Beta globulin followed by hybridization to a linear probe array (Roche Molecular Systems).

Report of Findings:

Each participant with a positive test result will receive a letter reporting the results.