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Protocol - Serum or Plasma Ferritin

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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.

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

Protocol Name from Source:

This section will be completed when reviewed by an Expert Review Panel.

Availability:

Publicly available

Personnel and Training Required

Phlebotomist

Equipment Needs

Laboratory that can perform the serum ferritin test.

Requirements
Requirement CategoryRequired
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

Life Stage:

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

Participants:

All ages

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

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
StandardNameIDSource
Common Data Elements (CDE) Serum Ferritin Laboratory Procedure Outcome Value 2971930 CDE Browser
Process and Review

This section will be completed when reviewed by an Expert Review Panel.

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 NameVariable IDVariable DescriptionVersiondbGaP Mapping
PX811301_SerumPlasmaFerritin_Amount PX811301070000 Ferritin level 4 N/A
PX811301_SerumPlasmaFerritin_Assay_Repeatability PX811301100000 Repeatability of the ferritin assay 4 N/A
PX811301_SerumPlasmaFerritin_Blood_DrawTube_Deviation PX811301050000 Record reasons for a tube not being drawn according to the protocol. 4 N/A
PX811301_SerumPlasmaFerritin_Blood_Draw_Results PX811301040000 Record the results of the blood draw. 4 N/A
PX811301_SerumPlasmaFerritin_Chemotheraphy_4weeks PX811301020000 Have you received cancer chemotherapy in the past four weeks or do you anticipate such therapy in the next four weeks? 4 N/A
PX811301_SerumPlasmaFerritin_Coefficients_Variation_Assay PX811301110000 Coefficients of variation of the ferritin assay 4 N/A
PX811301_SerumPlasmaFerritin_Equipment_Make PX811301080000 Make of the equipment used to perform the ferritin assay 4 N/A
PX811301_SerumPlasmaFerritin_Equipment_Manufacturer PX811301090000 Manufacturer of the equipment used to perform the ferritin assay 4 N/A
PX811301_SerumPlasmaFerritin_Gender PX811301030000 Gender 4 N/A
PX811301_SerumPlasmaFerritin_Hemophilia PX811301010000 Do you have hemophilia? 4 N/A
PX811301_SerumPlasmaFerritin_Venipuncture_Comments PX811301060000 Record any comments about the venipuncture. 4 N/A
Research Domain Information
Measure Name:

Serum or Plasma Ferritin

Release Date:

July 30, 2015

Definition

A bioassay to measure the serum concentration of ferritin (i.e., iron).

Purpose

This measure can be used to evaluate an individual’s iron metabolism, which is important for determining the presence and severity of anemia, and the assessment of iron therapy. Additionally this measure is used to assess iron overload (accumulation of iron in the body), which is associated with hereditary hemochromatosis and with transfusion therapy for many clinical conditions including sickle cell disease, thalassemia, other rare anemias, Hodgkin’s disease, acute leukemia, hemochromatosis, and carcinomas of many tumor types.

Keywords

Serum ferritin, plasma ferritin, iron, anemia, sickle cell disease, SCD, thalassemia, iron overload, hereditary hemochromatosis, iron deficiency, lung, colon, liver, prostate, acute leukemia, Hodgkin’s disease, hemochromatosis, carcinoma, NHANES