Form unnumbered Att. A. Dried Blood Spot Protocol

Attachment A.

Protocol for Dried Blood Spot Methodology Study (ages 20+)

National Health and Nutrition Examination Survey (NHANES)

Dried Blood Spot (DBS) Methodology Study

OMB no. 0920-0237

Expires: 12/31/2011

Assurance of confidentiality – All information which would permit identification of an

individual, a practice, or an establishment will be held confidential, will be used for

statistical purposes only by NCHS staff, contractors, and agents only when required and with necessary controls, and will not be disclosed or released to other persons without the consent of the individual or establishment in accordance with section 308(d) of the Public Health Service Act (42 USC 242m) and the Confidential Information Protection and Statistical Efficiency Act (PL-107-347).

Public reporting burden of this collection of information is estimated to average 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 (0920-0237).

Dried Blood Spot (DBS) Methodology Study Protocol:

Eligibility: Sample persons aged 20 years or older are eligible for the DBS Methodology Study.

Informed Consent: Informed consent will be obtained verbally in the phlebotomy room.

Exclusion Criteria: The exclusions are refusal for either venipuncture or finger stick, and phlebotomy exclusion criteria.

Study Design: DBS Collection at the Mobile Examination Center Component

Specimen Collection:

During phlebotomy, an EDTA tube will also be filled for the DBS methodology study. After phlebotomy is completed, while the participant is still in the phlebotomy room, blood spots from finger stick will be collected. The MEC staff will use a contact-activated lancet to draw blood from the middle or ring finger of the hand opposite the arm that was used for the venipuncture. In the event that both arms are used for the blood draw, either hand may be used for the blood spot.

Blood from the finger will be deposited on 3 separate filter-paper circles, on a card designed for this purpose. At most two fingers (on the same hand) will be lanced. Each circle on the Blood Spot Card should be at least 80% filled. Only one drop of blood may be placed on each circle on the Blood Spot Card. 

Blood spots, from venous blood already collected in an EDTA tube during phlebotomy (as described above), will be made later in the laboratory.

Report of Findings:

The results of this DBS Methodology Study will not be reported to the participant.