Protocol - Serum or Plasma Ferritin
- Aspartate Aminotransferase Level
- Bilirubin Level
- Complete Blood Count (CBC)
- Lactate Dehydrogenase Level
- Reticulocyte Count
Description
The National Health and Nutrition Examination Survey (NHANES) 2009-2010 Laboratory Procedures Manual for serum/plasma ferritin testing provides comprehensive instructions for processing and storing blood samples to determine an individual’s serum ferritin level. Because there are many comparable assays and instruments for measuring ferritin, the protocol also provides basic guidelines to aid comparability among different studies.
Specific Instructions
The National Health and Nutrition Examination Survey (NHANES) instructions for drawing, processing, and storing blood provide a standard methodology used successfully for many years to ensure comparable results across study sites. However, the Sickle Cell Disease Cardiovascular, Pulmonary, and Renal Working Group notes that certain aspects (e.g., exclusion criteria) of the NHANES protocol are study specific and might not be applicable to all types of studies (e.g., sickle cell disease). Investigators who want to include participants that have hemophilia or have received cancer chemotherapy in the last 4 weeks will need to implement special venipuncture procedures.
The Working Group acknowledges that the results of serum ferritin testing is affected by inflammation, liver damage, and ascorbate status.
Collection of blood samples for the measurement of analytes requires a general determination of whether to use serum or plasma for the assay and also a determination of the type of collection tube to be obtained. For example, if serum is to be used, a determination needs to be made as to whether red top or serum gel separator collection tubes are used. While comparable values are obtained for many analytes from either serum or plasma, there may be situations where differences are more pronounced and serum- or plasma-specific norms will be needed for references. The NHANES protocol presented here uses red top/serum separator tubes. At times it may be possible to collect both, but other considerations such as participant burden may be the deciding factor. It is important to match assay type with sample type. Some automated devices may preclude the use of serum, for example, while others may be optimized for it. Investigators should choose methods of collection that match the methods of analysis. This will best be done by communicating with the laboratory where the proposed assays will be performed. They will become an important partner with you in ensuring that there is compatibility from collection to assays to interpretation and reporting of levels and results
Availability
This protocol is freely available; permission not required for use.
Protocol
The following is a summary version of the full National Health and Nutrition Examination Survey protocol.
Exclusion Criteria
Persons will be excluded from this component if they:
- Report that they have hemophilia; or
- Report that they have received cancer chemotherapy in the last 4 weeks
SP = Sample Person.
1. Do you have hemophilia?
1 [ ] Yes
2 [ ] No
7 [ ] Refused
9 [ ] Don’t Know
If the SP answers "Yes," the SP is excluded from the blood draw.
If SP answers "No" or "Don’t Know," blood is drawn from the SP.
2. Have you received cancer chemotherapy in the past four weeks or do you anticipate such therapy in the next four weeks?
1 [ ] Yes
2 [ ] No
7 [ ] Refused
9 [ ] Don’t Know
If the SP answers "Yes," the SP is excluded from the blood draw.
If SP answers "No" or "Don’t Know," blood is drawn from the SP.
Venipuncture Procedures
Editor’s Note: Please review chapter 4 of the Laboratory Procedures Manual from the 2009-2010 National Health and Nutrition Examination Survey (NHANES) for a full description of phlebotomy procedures. This manual is posted here, and is also available at the NHANES website: www.cdc.gov/nchs/data/nhanes/nhanes_09_10/lab.pdf
Venipuncture should generally be performed using the median cubital, cephalic, or basilic veins in the left arm unless this arm is unsuitable. If the veins in the left arm are unsuitable, look for suitable veins on the right arm. If the veins in the antecubital space on both arms are not suitable, then look for veins in the forearm or dorsal side of the hand on the left arm/hand and then the right arm/hand.
Fill a 3 or 4 ml K3 EDTA tube with blood.
Recording the Results of the Venipuncture Procedure
Immediately after completing the venipuncture, record the results of the blood draw, the reasons for a tube not being drawn according to the protocol, and any comments about the venipuncture. Collection tube should be standardized across the study duration.
Laboratory Assay for Ferritin
The Sickle Cell Disease Cardiovascular, Pulmonary, and Renal Working Group notes that there are a number of different assays and instruments that are appropriate to measure ferritin. Once an assay is chosen for a particular study, the Working Group recommends that no changes in the protocol be made over the course of the study. To aid comparability, the Working Group recommends that the investigator record the make and manufacturer of equipment used and the repeatability and coefficients of variation for the assay.
Reference Ranges (Normal Values) for Ferritin
Ferritin reference ranges are assay-specific. The Roche Diagnostics kit used by NHANES specifies expected values of 30-400 ng/mL for men and 13-150 ng/mL for women.
Note: A full description of the National Health and Nutrition Examination Survey procedure for serum ferritin testing can be found in the 2009-2010 Laboratory Procedure Manual posted here, and is also available at the NHANES website: www.cdc.gov/nchs/data/nhanes/nhanes_09_10/FERTIN_F_met_ferritin.pdf
Personnel and Training Required
Phlebotomist
Equipment Needs
Laboratory that can perform the serum ferritin test.
Requirements
| Requirement Category | Required |
|---|---|
| Major equipment | No |
| 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
All ages
Selection Rationale
The Sickle Cell Disease Cardiovascular, Pulmonary, and Renal Working Group selected the National Health and Nutrition Examination Survey (NHANES) 2009-2010 Laboratory Procedures Manual for serum ferritin testing because the method is well validated and the equipment used is widely available.
Language
English
Standards
| Standard | Name | ID | Source |
|---|---|---|---|
| Human Phenotype Ontology | Abnormal serum ferritin | HP:0040133 | HPO |
| caDSR Form | PhenX PX811301 - Serum Or Plasma Ferritin | 6254198 | caDSR Form |
Derived Variables
None
Process and Review
Not applicable.
Protocol Name from Source
National Health and Nutrition Examination Survey Questionnaire (NHANES), Laboratory Procedures Manual, 2009-2010
Source
Centers for Disease Control and Prevention (CDC). (2009). National Health and Nutrition Examination Survey Questionnaire. Laboratory Procedures Manual. Hyattsville, MD: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention.
General References
Adamkiewicz, T. V., Abboud, M. R., Paley, C., Olivieri, N., Kirby-Allen, M., Vichinsky, E., Casella, J. F., Alvarez, O. A., Barredo, J. C., Lee, M. T., Iyer, R. V., Kutlar, A., McKie, K. M., McKie, V., Odo, N., Gee, B., Kwiatkowski, J. L., Woods, G. M., Coates, T., Wang, W., & Adams, R. J. (2009). Serum ferritin level changes in children with sickle cell disease on chronic blood transfusion are nonlinear and are associated with iron load and liver injury. Blood, 114(21), 4632-4638.
Drasar, E., Vasavda, N., Igbineweka, N., Awogbade, M., Allman, M., & Thein, S.L. (2012). Serum ferritin and total units transfused for assessing iron overload in adults with sickle cell disease. British Journal of Haematology, 157(5), 645-647.
Protocol ID
811301
Variables
Export Variables| Variable Name | Variable ID | Variable Description | dbGaP Mapping | |
|---|---|---|---|---|
| PX811301_SerumPlasmaFerritin_Amount | ||||
| PX811301070000 | Ferritin level | N/A | ||
| PX811301_SerumPlasmaFerritin_Assay_Repeatability | ||||
| PX811301100000 | Repeatability of the ferritin assay | N/A | ||
| PX811301_SerumPlasmaFerritin_Blood_DrawTube_Deviation | ||||
| PX811301050000 | Record reasons for a tube not being drawn more | N/A | ||
| PX811301_SerumPlasmaFerritin_Blood_Draw_Results | ||||
| PX811301040000 | Record the results of the blood draw. | N/A | ||
| PX811301_SerumPlasmaFerritin_Chemotheraphy_4weeks | ||||
| PX811301020000 | Have you received cancer chemotherapy in the more | N/A | ||
| PX811301_SerumPlasmaFerritin_Coefficients_Variation_Assay | ||||
| PX811301110000 | Coefficients of variation of the ferritin assay | N/A | ||
| PX811301_SerumPlasmaFerritin_Equipment_Make | ||||
| PX811301080000 | Make of the equipment used to perform the more | N/A | ||
| PX811301_SerumPlasmaFerritin_Equipment_Manufacturer | ||||
| PX811301090000 | Manufacturer of the equipment used to more | N/A | ||
| PX811301_SerumPlasmaFerritin_Gender | ||||
| PX811301030000 | Gender | N/A | ||
| PX811301_SerumPlasmaFerritin_Hemophilia | ||||
| PX811301010000 | Do you have hemophilia? | N/A | ||
| PX811301_SerumPlasmaFerritin_Venipuncture_Comments | ||||
| PX811301060000 | Record any comments about the venipuncture. | N/A | ||