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Protocol - Concentrations of Trace Metals

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Description:

Blood is collected from the subject in a pre-screened 3 ml lavender top tube and then refrigerated until analyses by high-performance liquid chromatography coupled to inductively coupled plasma dynamic reaction cell mass spectrometry (ICP-DRC-MS). This device measures concentrations of cadmium, lead, manganese, selenium, and mercury in the blood.

Protocol:

Administer the following questions prior to blood collection.

1. Do you have hemophilia or any bleeding disorder?

[ ] Yes

[ ] No

[ ] Don’t Know

[ ] Refused

      • If the participant answers "Yes" or "Don’t know," or refuses to answer, blood will not be collected.

2. Have you had cancer chemotherapy within the past 4 weeks?

[ ] Yes

[ ] No

[ ] Don’t Know

[ ] Refused

      • If the participant answers "Yes" or "Don’t know," or refuses to answer, blood will not be collected.

3. Have you had any problems with a blood draw in the past?

[ ] Yes

[ ] No

[ ] Don’t Know

[ ] Refused

  • If the participant answers "Yes," go to question 4.
  • If the participant answers "No," "Don’t know," or refuses to answer, go to question 5.

4. What problems have you had with a blood draw in the past?

______________________________

  • Record the types of problems that the participant experienced during previous blood draws.
  • If the participant refuses to answer or does not remember specifically what type of problem was experienced in the past, record and go to question 5.

5. When was the last time you had anything to eat or drink other than water?

Date ____________ mm/dd/yyyy

Time ____________ am/pm

6. Have you had sweetener or milk added to a drink, such as coffee or tea, in the last 8 hours?

[ ] Yes

[ ] No

[ ] Don’t Know

[ ] Refused

  • Record the participant’s response.
  • "Sweetener" includes sugar, honey, and flavored creamers. If the participant consumed an artificial sweetener in coffee, tea, or a diet soda, record "No."

7. Have you had alcohol such as beer, wine, or liquor in the last 8 hours?

[ ] Yes

[ ] No

[ ] Don’t Know

[ ] Refused

8. Have you chewed gum, or used breath mints, lozenges, cough drops, or other cough or cold remedies in the last 8 hours?

[ ] Yes

[ ] No

[ ] Don’t Know

[ ] Refused

9. Have you used antacid, laxatives, or anti-diarrheal medications in the last 8 hours?

[ ] Yes

[ ] No

[ ] Don’t Know

[ ] Refused

10. Have you taken a dietary supplement such as vitamins or minerals in the last 8 hours?

[ ] Yes

[ ] No

[ ] Don’t Know

[ ] Refused

11. Has a doctor ever told you that you had diabetes?

[ ] Yes

[ ] No

[ ] Don’t Know

[ ] Refused

  • If the participant answers "Yes," go to question 12.
  • If the participant answers "No" and is pregnant probe "This includes gestational diabetes." If the participant still answers "No" after probe, prepare to draw participant’s blood.
  • If the participant is not pregnant and answers that she had gestational diabetes while pregnant, indicate that this does not include gestational diabetes and prepare to draw the participant’s blood.
  • If the participant answers "No" and is not pregnant, prepare to draw the participant’s blood.

12. Have you taken any insulin in the last 8 hours?

[ ] Yes

[ ] No

[ ] Don’t Know

[ ] Refused

      • Record the participant’s response and prepare to draw the participant’s blood.

The entire standard operating procedure from the National Children’s Study that includes the questions, venipuncture supplies, and venipuncture procedure appears here.

Follow a standard venipuncture protocol but lavender top vacutainer tube must be collected first. Draw the blood with a stainless steel needle and use a pre-screened vacutainer tube.

The optimal amount of blood in lavender top tube is 1 to 2 ml. The minimum amount for analyses is 0.4 ml.

The lavender top tube includes a strong anticoagulant and the whole blood should never be centrifuged. The lavender top tube with blood may be refrigerated during transport. The blood may be aliquoted to cryovials and placed in a -20 C freezer prior to analyses.

Concentrations of cadmium, lead, manganese, selenium, and mercury are measured in EDTA-anticoagulated whole blood using high performance liquid chromatography coupled to inductively-coupled-plasma dynamic-reaction-cell mass spectrometry (ICP-DRC-MS).

Levels of concern for mercury in blood are >100 μg/L for children (6 yr and younger) and >200 μg/L for adults. Levels of concern for cadmium in blood is >5 μg/L (CDC/DLS, 2012). Elevated blood levels are 5 μg/dL for children (6 yr. and younger) and adults (CDC, 2012). The entire laboratory procedure is available here.

Protocol Name from Source:

National Children’s Study Biospecimen Adult Blood Procedures: Standard Operating Procedures

National Health and Nutrition Examination Survey, CDC Laboratory Procedure Manual for Cadmium, Lead, Manganese, Mercury, and Selenium

Availability:

Publicly available

Personnel and Training Required

The blood draw and processing procedures should be performed by a certified laboratory technician or a phlebotomist.

Equipment Needs

Highly specialized laboratory equipment is necessary to perform accurate trace metal analyses. A stainless steel needle should be used for venipuncture. Collection tubes need to be pre-screened for these metals prior to venipuncture.

Requirements
Requirement CategoryRequired
Major equipment Yes
Specialized training No
Specialized requirements for biospecimen collection No
Average time of greater than 15 minutes in an unaffected individual No
Mode of Administration

Bioassay

Life Stage:

Infant, Toddler, Child, Adolescent, Adult, Senior, Pregnancy

Participants:

Age 1 year and older, Pregnant woman

Specific Instructions:

If the subject is a pregnant woman, the date and gestational age at the time of the venipuncture should be recorded. There may be a need to assess these exposures during a particular time period during the woman’s pregnancy based on the experimental design. These methods are usable over the entirety of pregnancy.

Selection Rationale

The National Children's Study (NCS) was one of the largest pregnancy cohort studies in the United States, and the biospecimen collection methods have been validated in other studies.

The National Health and Nutrition Examination Survey (NHANES) is a major cross-sectional study in the United States, and the methods have been validated on other studies.

Language

English

Standards
StandardNameIDSource
Common Data Elements (CDE) Serum Trace Metal Concentration Microgram per Milliliter 5633806 CDE Browser
Derived Variables

None

Process and Review

The Expert Review Panel has not reviewed this measure yet.

Source

Centers for Disease Control and Prevention, National Health and Nutrition Examination Survey (NHANES) 2003-2004 (2012). Laboratory procedure manual for cadmium, lead, manganese, mercury, and selenium. Atlanta, GA: Author.

Eunice Kennedy Shriver National Institute of Child Health and Human Development. (2014). National Children’s Study, Biospecimen adult blood procedures: Standard operating procedures. Rockville, MD: Author.

General References

Canfield, R. L., Henderson, C. R. J., Cory-Slechta, D. A., Cox , C., Jusko, T. A., & Lanphear, B. P. (2003). Intellectual impairment in children with blood lead concentrations below 10 μg per deciliter. New England Journal of Medicine, 348(16), 1517-1526.

Centers for Disease Control and Prevention (CDC). (2012). CDC Response to Advisory Committee on Childhood Lead Poisoning Prevention Recommendations in "Low Level Lead Exposure Harms Children: A Renewed Call for Primary Prevention." Atlanta, GA: Author.

Holmes, P., James, K. A. F., & Levy, L. S. (2009). Is low-level environmental mercury exposure of concern to human health? Science of the Total Environment, 408(2), 171-182.

Protocol ID:

240501

Variables:
Export Variables
Variable NameVariable IDVariable DescriptionVersiondbGaP Mapping
Research Domain Information
Measure Name:

Concentrations of Trace Metals

Release Date:

January 31, 2017

Definition

Collect and analyze a blood sample to determine the concentrations of several trace metals. These metals may include cadmium, lead, manganese, selenium, and mercury.

Purpose

This measure is to determine the levels of trace metals in the subject’s blood. High concentrations of metals in the blood may cause neurodevelopmental problems, particularly in young children or a developing fetus.

Keywords

Cadmium, lead, manganese, selenium, mercury, venipuncture, National Children’s Study, NCS, National Health and Nutrition Examination Survey, NHANES, Centers for Disease Control and Prevention, CDC