NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
Diagnosing iron deficiency and iron-overload conditions
Testing Algorithm Delineates situation(s) when tests are added to the initial order. This includes reflex and additional tests.
See Hereditary Hemochromatosis Algorithm in Special Instructions.
Special Instructions and Forms Describes specimen collection and preparation information, test algorithms, and other information pertinent to test. Also includes pertinent information and consent forms to be used when requesting a particular test
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
Specimen Type Describes the specimen type needed for testing
Specimen Required Defines the optimal specimen. This field describes the type of specimen required to perform the test and the preferred volume to complete testing. The volume allows automated processing, fastest throughput and, when indicated, repeat or reflex testing.
Preferred: Serum gel
Acceptable: Red top
Specimen Volume: 0.6 mL
Specimen Minimum Volume Defines the amount of specimen required to perform an assay once, including instrument and container dead space. Submitting the minimum specimen volume makes it impossible to repeat the test or perform confirmatory or perform reflex testing. In some situations, a minimum specimen volume may result in a QNS (quantity not sufficient) result, requiring a second specimen to be collected.
Mild OK; Gross reject
Mild OK; Gross OK
Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.
|Serum||Refrigerated (preferred)||7 days|
Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
Ferritin is a high-molecular-weight protein that contains approximately 20% iron. It occurs normally in almost all tissues of the body but especially in hepatocytes and reticuloendothelial cells, where it serves as an iron reserve. Ferritin is also present in the serum in minute amounts, where it appears to reflect iron stores in normal individuals.
Ferritin plays a significant role in the absorption, storage, and release of iron. As the storage form of iron, ferritin remains in the body tissues until it is needed for erythropoiesis. When needed, the iron molecules are released from the apoferritin shell and bind to transferrin, the circulating plasma protein that transports iron to the erythropoietic cells.
A low serum ferritin value is thought to be the best laboratory indicator of iron depletion. Virtually all patients with low serum iron and low ferritin have iron deficiency. Serum ferritin is clinically useful in distinguishing between iron-deficiency anemia (serum ferritin levels diminished) and "anemia of chronic disease" (serum ferritin levels usually normal or elevated). Serum ferritin is a good screening test in separating erythrocyte microcytosis due to iron deficiency (low values) from microcytosis related to thalassemia minor (normal or high values). An iron-depletion state with a decreased serum ferritin value is quite common among menstruating and reproductively active females and in children.
Ferritin is an acute phase reactant. A normal serum ferritin value, therefore, cannot be used to exclude iron deficiency if a hepatic, malignant, or inflammatory condition is present.
A high serum ferritin value is seen in hemochromatosis and other iron-overload states, as well as acute hepatitis, Gaucher disease, malignancies, and chronic inflammatory disorders.
Reference Values Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.
Males: 24-336 mcg/L
Females: 11-307 mcg/L
Hereditary hemochromatosis or other iron-overload states, acute hepatitis, and Gaucher disease are associated with very high serum ferritin levels. Slight-to-moderate elevation occurs in many malignancies and in chronic inflammatory disorders.
Iron deficiency (uncomplicated)
Males: <24 mcg/L
Females: <11 mcg/L
Males: >336 mcg/L
Females: >307 mcg/L
In hemochromatosis, ferritin is often >1,000 mcg/L
For more information about hereditary hemochromatosis testing, see Hereditary Hemochromatosis Algorithm in Special Instructions.
Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
A normal serum ferritin value cannot be used to exclude iron deficiency if a hepatic, malignant, or inflammatory condition is present (ferritin is an acute phase reactant).
Some patients who have been exposed to animal antigens, either in the environment or as part of treatment or imaging procedure, may have circulating antianimal antibodies present. These antibodies may interfere with the assay reagents to produce unreliable results.
Clinical Reference Provides recommendations for further in-depth reading of a clinical nature
1. Fairbanks VF, Beutler E: Iron Metabolism. In Williams Hematology. Edited by E Beutler, MA Lichtman, BS Coller, et al. New York. McGraw-Hill Book Company, 2001, pp 295-304
2. Fairbanks VF, Brandhagen DJ: Disorders of iron storage and transport. In Williams Hematology. Edited by E Beutler, MA Lichtman, BS Coller, et al. New York. McGraw-Hill Book Company, 2001, pp 489-502
3. Brugnara C: Iron deficiency and erythropoiesis: new diagnostic approaches. Clin Chem 2003 Oct;49(10):1573-1578
4. Schilsky ML, Fink S: Inherited metabolic liver disease. Curr Opin Gastroenterol 2006 May;22(3):21
Method Description Describes how the test is performed and provides a method-specific reference
The instrument used is a Beckman Coulter Unicel DXI 800. The Access Ferritin assay is a 2-site immunoenzymatic ("sandwich") assay. A sample is added to a reaction vessel with goat antiferritin-alkaline phosphatase conjugate, and paramagnetic particles coated with goat antimouse:mouse antiferritin complexes. Serum ferritin binds to the immobilized monoclonal antiferritin on the solid phase, while the goat antiferritin enzyme conjugate reacts with different antigenic sites on the ferritin molecules. After incubation in a reaction vessel, materials bound to the solid phase are held in a magnetic field, while unbound materials are washed away. Chemiluminescent substrate Lumi-Phos 530 is added to the vessel and light generated by the reaction is measured with a luminometer. The light production is directly proportional to the concentration of ferritin in the sample. The amount of analyte in the sample is determined from a stored, multipoint calibration curve. (Package insert: Beckman Coulter Inc, Fullerton, CA 2009).
Day(s) and Time(s) Test Performed Outlines the days and times the test is performed. This field reflects the day and time the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time required before the test is performed. Some tests are listed as continuously performed, which means assays are performed several times during the day.
Monday through Friday 5 a.m. – 12 a.m., Saturday 6 a.m. – 6 p.m.
Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.
Same day/1 day
Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result
Specimen Retention Time Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
Performing Laboratory Location The location of the laboratory that performs the test
Test Classification Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer's instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR), Investigation Use Only (IUO) product, or a Research Use Only (RUO) product.
This test has been cleared or approved by the U.S. Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.
CPT Code Information Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
LOINC® Code Information Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the result codes returned for this test or profile.
|Result ID||Reporting Name||LOINC Code|