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

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.

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 20-59 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

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

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

OP96010

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 12-59 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.

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.

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.

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

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

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:

Other Laboratory Tests Bone makers Bone Alkaline Phosphatase Urinary N-telopeptides FSH/LH (females 35-60 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 35-60 as an assessment of menopause status and we have added PSA testing in 2001.

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.

Additions to the Laboratory Component-2001 Vaginal Swab Collection (females age 14-49 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 14-49 to self collect two vaginal swabs to assess Bacterial vaginosis (gram stain) and PCR testing for Trichomonas

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

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

Additions to the Laboratory Component-2002 Vaginal Swab Collection (females age 14-59 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 14-59 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 14-59 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.

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.