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Protocol - Concentrations of Flame Retardants

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Protocol Name from Source:

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

National Health and Nutrition Examination Survey (NHANES), CDC Laboratory Procedure Manual, Polybrominated Diphenyl Ethers (PBDEs)

Availability:

Publicly available

Description:

Blood is collected from the subject in a pre-screened 10 ml red-top tube, centrifuged, and the serum is transported or shipped on dry ice to the laboratory.

Analysis is by isotope-dilution high-resolution mass spectrometry (ID-HRMS). This device measures concentrations of polybrominated diphenyl ethers (PBDEs) in serum.

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 that includes the questions, venipuncture supplies, and venipuncture procedure appears [alink[05_NCS_AdultBlood_SOP.pdf|here]].

Follow a standard venipuncture protocol and collect blood in a 10 ml red-top vacutainer tube. Draw the blood with a stainless steel needle and use a pre-screened vacutainer tube.

An optimum amount of serum is 4 ml and the minimum is 0.5 ml.

For collection, loosen the tourniquet immediately after blood flow is established and release entirely as the last tube fills. Completely fill all the Vacutainer tubes and then withdraw the needle with a slow but firm motion. Red-top tubes should not be inverted or mixed. Label all tubes. Place the red-top tubes upright in a rack and allow them to clot at room temperature for 30 minutes. Centrifuge the red-top tubes for 10 minutes at the RPM necessary to attain a force of 1,000 x g. Using a transfer pipette, pipette the serum from each participant’s red-top tubes into the Wheaton Bottle and cap. Check to make sure that the numbers on the labels are the same. DO NOT ALLOW SERUM TO REMAIN IN CONTACT WITH THE CLOT FOR LONGER THAN 1 HOUR AFTER THE SPECIMEN IS COLLECTED. Mix the serum gently, cap each bottle and place upright in a -70° C freezer and store at the same temperature until shipment. The time between collecting blood and freezing serum should not be more than 1 1/2 hours. Note on the sample log if a sample is turbid or hemolyzed, or if the serum was left in contact with red cells for more than 1 hour or left at room temperature for more than 90 minutes before freezing.

The criteria for an unacceptable specimen are either a low volume (< 0.1 mL) or suspected contamination due to improper collection procedures or collection devices. In all such cases, request a second serum specimen. Contamination of specimen could occur from contact with indoor dust from improper handling.

The entire laboratory procedure is located [alink[03_CDC_Lab_Procedures_PBDEs.pdf|here]].

Normal concentration range (ng/g lipid) of Brominated flame retardants (BFRs) in human serum appear in table below.

Compound

Median

Quartile Range

<Limit of Detection (LOD)

BDE-47

8.4

5.4-18

10%

BDE-100

1.7

1.0-3.5

6%

BDE-99

1.7

1.4-2.5

16%

BB-153

0.33

0.27-1.3

23%

BDE-154

0.21

0.21-0.28

71%

BDE-85

0.21

0.21-0.37

56%

BDE-153

2.2

1.2-3.8

3%

BDE-183

0.21

0.21-0.21

65%

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 analyses. A stainless steel needle should be used for venipuncture. Collection tubes need to be pre-screened for these toxicants prior to venipuncture.

Requirements

Requirement CategoryRequired
Average time of greater than 15 minutes in an unaffected individualNo
Major equipmentYes
Specialized requirements for biospecimen collectionNo
Specialized trainingNo

Mode of Administration

Self-administered

Life Stage:

Adolescent, Adult, Senior, Pregnancy

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.

Research Domain Information

Release Date:

January 31, 2017

Definition

Collect and analyze a blood sample to determine the concentrations of several polybrominated diphenyl ethers (PBDEs), which are chemicals used as flame retardants.

Purpose

To determine the concentrations of polybrominated diphenyl ethers (PBDEs) in the subject’s blood. High concentrations of PBDEs in the blood of a pregnant woman or young child may lead to neurobehavioral problems.

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 Polybrominated Diphenyl Ether Concentration in Nanogram Per Gram Lipid Weight5633522CDE Browser

Process and Review

The Expert Review Panel has not reviewed this measure yet.

Source

Centers for Disease Control and Prevention (CDC), National Health and Nutrition Examination Survey (NHANES) 2005-2006, (2011). CDC laboratory procedure manual, Polybrominated diphenyl ethers (PBDEs). 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

Centers for Disease Control and Prevention (CDC). (2013-14). National Health and Nutrition Examination Survey (NHANES), Mobile Examination Center (MEC) laboratory procedures manual. Atlanta, GA: Author.

Eskenazi, B., Chevrier, J., Rauch, S. A., Kogut, K., Harley, K. G., Johnson, C., Trujillo, C., Sjödin, A., & Bradman, A. (2013). In utero and childhood polybrominated diphenyl ether (PBDE) exposures and neurodevelopment in the CHAMACOS study. Environmental Health Perspectives, 121, 257-262.

Sjödin, A., Wong, L. Y., Jones, R. S., Park, A., Zhang, Y., Hodge, C., . . . Patterson, D. G., Jr. (2008). Serum concentrations of polybrominated diphenyl ethers (PBDEs) and polybrominated biphenyl (PBB) in the United States population: 2003-2004. Environmental Science and Technology, 42(4), 1377-1384.

Protocol ID:

240201

Variables:

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