1. NHANES Laboratory Component Barbara Lindstrom, M.SPH., Westat
Geraldine McQuillan, Ph.D., Brenda Lewis, MPH, David Lacher, MD, Qiyuan Pan, Ph.D., NCHS
Barbara Lindstrom, M.SPH., Westat
The NHANES laboratory component is coordinated by a small group of people: Brenda Lewis runs the day-to day activities from the NCHS side; Dave Lacher is our pathologist who is in charge of the quality control of the laboratory data and Qiyuan Pan is our data management specialist. Barbara Lindstrom from Westat is in charge of the NHANES laboratory filed staff
Centers for Disease Control and Prevention
National Center for Health Statistics

2. NHANES Laboratory Component
Specimen collection
Specimen processing
Specimen storage
Specimen shipping
Specimen testing
Quality control
Specimen tracking
Laboratory QC
The laboratory component of the survey consists of the collection, processing and storage of the specimens with the associated quality control.

3. Specimens Collected Blood whole blood serum plasma blood clots Urine
Home tap water
Lead dust wipes
Swabs
nasal
vaginal
Blood is obtained from participants age 1 + and urine is collected from individuals age 6+.
Home tap water from a half sample of participants age years is processed by the laboratory and dust wipes collected by the interviewers in households of 1-5 year old participants is also processed and shipped in the laboratory

4. Venipuncture Protocol
About 100 ml of blood obtained from those age 12+

5. Blood Collection Procedure
Administering a questionnaire
exclusions for hemophilia
exclusion for chemotherapy (within 4 weeks)
fasting questions (all 1+)
fasting
(all SPs age 12 or more years)
morning - 9 hrs
afternoon or evening -6 hrs.
Performing venipuncture
Collecting specimens for special studies
collecting nasal swab
The phelebotomist will administer a safety questionnaire that includes: question about hemophilia or chemotherapy for cancer in the last month. Fasting questions are also asked for all participants, though only individuals age 12+ are asked to fast – 9 hours for those attending the morning session and 6 hours for those attending the afternoon or evening session.
The phlebotomist will then perform the venipuncture and collect specimens for special studies which at present is a nasal swab for MRSA

6. OP96010

7. MEC Laboratory CBC and differential Pregnancy test
Blood and urine processing
290 laboratory assays
44 vials of blood
14 vials of urine
13 other containers (water, swabs, wipes)
28 laboratories
We only perform 2 laboratory assays in the MEC laboratory, the CBC and differential (Coulter MAXIM) and a pregnancy test on females ages years and girls 8-11 who are menstruating.
Otherwise the laboratory technicians process the blood and urine collected for the 290 laboratory tests included in the survey. For an adult participants this means 44 vials of blood, 14 vials of urine and 13 other containers that are shipped too 28 laboratories, both at CDC and contract laboratories throughout the US.

8. Laboratory Protocol Trends Complement the physical exam
assays the same or comparable across surveys
Complement the physical exam
bone markers
Bio-measurements (different measurements by age)
nutrition
environmental
infectious disease
chronic diseases
In order to be part of the laboratory protocol, an assay must be considered valid and accepted by the scientific community as providing reliable results.
In addition if trends in a measurement is important to monitor the Nation’s health, the lab measurements must be comparable across surveys. This is often challenging since laboratory science is constantly evolving.
Measurements are often included that complement other exam components such as the bone markers and the DXA Scan.
Finally many of the lab measurements are outcome measures in themselves or covariates needed in epidemiologic analysis These assays can be broadly categorized as Nutrition, Environmental, Infectious Disease, and Chronic Disease assays.

9. Nutrition Laboratory Tests
Iron Status
Erythrocyte Protoporphyrin
Iron/TIBC
Ferritin
Vitamin Status
RBC Folate
Serum Folate/Vitamin B12
Vitamin A/E/Carotenoids
Vitamin D
Homocysteine/methylmalonic acid
The nutrition measures can be broadly categorized into Iron Status measures and Vitamin Status measures.

10. Environmental Laboratory Tests
Lead
Cadmium
Blood and urine Mercury
Pesticides, persistent/non-persistent
Cotinine
Urinary Iodine
Lead Dust
Volatile organic compounds
Thses are some examples of the environmental laboratory measures.
Blood and urine -total mercury
Lead dust in homes of children age 1-6 years

11. Infectious Disease Laboratory Tests
Hepatitis A, B, C, D, E
Sexually Transmitted Diseases
HIV
HSV-1 and 2
Chlamydia / Gonorrhea
Syphilis
Bacterial vaginosis /Trichomonas
HPV antigen and antibody
Measles/Varicella/Rubella
MRSA
Toxoplasmosis
There is an extensive ID component

12. Chronic Disease Laboratory Tests
Diabetes
Hemoglobin A1c
Glucose, Insulin and C-peptide
Heart Disease
Lipids, Fibrinogen, CRP
Thyroid Disease
TSH and Thyroxine
Kidney Disease
Urinary microalbumin
Clinical biochemistry profile - serum creatinine
For assessment of chronic diseases we look at:

13. Other Laboratory Tests
Bone makers
Bone Alkaline Phosphatase
Urinary N-telopeptides
FSH/LH (females yrs.)
Prostate Disease
Prostate Specific Antigen (males 40+)
Finally to compliment the DXA scan we have these bone markers. FSH and LS hormones are measures in females as an assessment of menopause status and we have added PSA testing in 2001.

14. Future Research Separate consent and storage Serum- Age 6+ years
Plasma- Age 6+ years
Urine- Age 6+ years
DNA- Age 20+ years
Urine 2 tubes stored.

15. Additions to the Laboratory Component-2001
Vaginal Swab Collection (females age years)
Bacterial vaginosis (BV)
Most common cause of vaginal discharge
Not an infection but a change in vaginal bacteria
Associated with premature labor and delivery
Infections after OB/GYN procedures
Trichomoniasis
Most common curable STD
No population based data
Causes reproductive health problems in women
Males rarely have symptoms
I would like to give more detail on the assays we have added since the last Data Users Conference. We are asking women ages to self collect two vaginal swabs to assess Bacterial vaginosis (gram stain) and PCR testing for Trichomonas

16. NHANES 2001 Additional Blood Tests Syphilis (age 18-49 years)
Two tests will be done (RPR and EIA)
Measure of recent infection (both tests positive)
Measure of remote infection (EIA positive)
Toxoplasma gondii (age 6-49 years)
Foodborne infection
Can cause congenital infections if pregnant women are infected
We have added two tests for syphilis so we have an estimate of recent and remote infection.
We are also looking at antibody to toxoplasma as part of our food safety component

17. NHANES 2001 Additional Tests Prostate Specific Antigen (males age 40+)
Detects prostate disease/cancer
Nasal swab collection (ages 1+)
Methicillin-resistant Staph aureus
Assessment of community acquired bacterial resistance to antibiotics
We are testing for PSA in men 40+
And we are very excited about our nasal swab collection to look for MRSA to assess community acquires bacterial resistance to antibiotics

18. Additions to the Laboratory Component-2002
Vaginal Swab Collection (females age years)
Human papillomavirus (HPV)
One of the most common sexually transmitted infections in the U.S.
Cervical infection with certain types of HPV is the strongest risk for cervical cancer.
No national surveillance system to measure the burden of HPV infections in the U.S.
Blood collection
HPV-16 antibody, males and females ages years
To determine the prevalence of infection in the population
In 2002 we added a third vaginal swab and extended the age range for this swab to years to assess current carriage of both high risk and low risk types of HPV.
In addition we are looking at lifetime prevalence of antibody in males and females in the same age range to HPV-16 the type most associated with of cervical cancer.

19. NHANES 2002 Follow-up Addition to Exam
Follow-up of HCV positive individuals
Phone survey 6 months after ROF sent
Questions on knowledge and health care received
Finally we are doing a follow-up of individuals who are HCV antibody positive to assess their previous knowledge of their infection status and the health care they have received since they received our report of finding letter.