Protocol - Concentrations of Trace Metals
- Current Pregnancy Status - Bioassay
- Gestational Age - Maternal Interview
- Gestational Age - Medical Record Abstraction
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.
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.
Availability
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.
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 Category | Required |
---|---|
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
Lifestage
Infant, Toddler, Child, Adolescent, Adult, Senior, Pregnancy
Participants
Age 1 year and older, Pregnant woman
Selection Rationale
The National Childrens 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
Standard | Name | ID | Source |
---|---|---|---|
caDSR Form | PhenX PX240501 - Concentrations Of Trace Metals | 6873036 | caDSR Form |
Derived Variables
None
Process and Review
Not applicable.
Protocol Name from Source
National Health and Nutrition Examination Survey (NHANES), Laboratory Procedure Manual, 2003-2004
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 VariablesVariable Name | Variable ID | Variable Description | dbGaP Mapping | |
---|---|---|---|---|
PX240501_Trace_Metals_Alcohol | ||||
PX240501070000 | Have you had alcohol such as beer, wine, or more | N/A | ||
PX240501_Trace_Metals_Antacid | ||||
PX240501090000 | Have you used antacid, laxatives, or more | N/A | ||
PX240501_Trace_Metals_Blood_Draw | ||||
PX240501030000 | Have you had any problems with a blood draw more | N/A | ||
PX240501_Trace_Metals_Blood_Draw_Problems | ||||
PX240501040000 | What problems have you had with a blood draw more | N/A | ||
PX240501_Trace_Metals_Chemotherapy | ||||
PX240501020000 | Have you had cancer chemotherapy within the more | N/A | ||
PX240501_Trace_Metals_Concentration | ||||
PX240501130000 | Serum Trace Metal Concentration Microgram more | N/A | ||
PX240501_Trace_Metals_Diabetes | ||||
PX240501110000 | Has a doctor ever told you that you had diabetes? | N/A | ||
PX240501_Trace_Metals_Dietary_Supplement | ||||
PX240501100000 | Have you taken a dietary supplement such as more | N/A | ||
PX240501_Trace_Metals_Gum | ||||
PX240501080000 | Have you chewed gum, or used breath mints, more | N/A | ||
PX240501_Trace_Metals_Hemophilia | ||||
PX240501010000 | Do you have hemophilia or any bleeding disorder? | N/A | ||
PX240501_Trace_Metals_Ingested_Date | ||||
PX240501050100 | When was the last time you had anything to more | N/A | ||
PX240501_Trace_Metals_Ingested_Time | ||||
PX240501050200 | When was the last time you had anything to more | N/A | ||
PX240501_Trace_Metals_Insulin | ||||
PX240501120000 | Have you taken any insulin in the last 8 hours? | N/A | ||
PX240501_Trace_Metals_Sweetener | ||||
PX240501060000 | Have you had sweetener or milk added to a more | N/A |
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
Measure Protocols
Protocol ID | Protocol Name |
---|---|
240501 | Concentrations of Trace Metals |
Publications
There are no publications listed for this protocol.