NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
Diagnosis and follow-up of medullary thyroid carcinoma
Adjunct to diagnosis of multiple endocrine neoplasia type II and familial medullary thyroid carcinoma
Occasionally useful in the diagnosis and follow-up of islet cell tumors
Automated Immunochemiluminometric Assay (ICMA)
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: Red top
Acceptable: Serum gel
Submission Container/Tube: Plastic vial
Specimen Volume: 0.8 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.
Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
In the normal physiological situation, calcitonin is a polypeptide hormone secreted by the parafollicular cells (also referred to as calcitonin cells or C-cells) of the thyroid gland. The main action of calcitonin is the inhibition of bone resorption by regulating the number and activity of osteoclasts. Calcitonin is secreted in direct response to serum hypercalcemia and may prevent large oscillations in serum calcium levels and excessive loss of body calcium. However, in comparison to parathyroid hormone and 1,25-dihydroxyvitamin D, the role of calcitonin in the regulation of serum calcium in humans is minor. Measurements of serum calcitonin levels are, therefore, not useful in the diagnosis of disorders of calcium homeostasis.
Malignant tumors arising from thyroid C-cells (medullary thyroid carcinoma: MTC) usually produce elevated levels of calcitonin. MTC is an uncommon malignant thyroid tumor, comprising <5% of all thyroid malignancies. Approximately 25% of these cases are familial, usually appearing as a component of multiple endocrine neoplasia type II (MENII, Sipple syndrome). MTC may also occur in families without other associated endocrine dysfunction, with similar autosomal dominant transmission as MENII, which is then called familial medullary thyroid carcinoma (FMTC). Mutations in the RET proto-oncogene are associated with MENII and FMTC.
Other neuroectodermal endocrine tumors, particularly islet cell tumors, may also produce calcitonin, but do so much less frequently. Calcitonin elevations also may occur with:
-Cancer of the lung, breast, or pancreas
-Intestinal, gastric, or bronchial carcinoids
-Chronic renal failure, Zollinger-Ellison syndrome, or pernicious anemia
-Pregnant females at term
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: <16 pg/mL
Females: <8 pg/mL
PEAK CALCIUM INFUSION
Males: < or =130 pg/mL
Females: < or =90 pg/mL
Although most patients with sporadic medullary thyroid carcinoma (MTC) have high basal calcitonin levels, 30% of those with familial MTC or multiple endocrine neoplasia type II (MENII) have normal basal levels. In the past, these individuals may have required a calcium infusion provocative test (short calcium infusion with blood drawing at 0, 5, and 10 minutes) to demonstrate the abnormality. Mutation screening (MENMS/80573 Multiple Endocrine Neoplasia Type 2 [2A, 2B, FMTC] Mutation Screen) of RET has largely superseded calcium infusion provocative testing. Calcium infusion tests are now only necessary in suspected familial cases belonging to 1 of the 5% to 10% of MEN/FMTC (multiple endocrine neoplasia/familial medullary thyroid carcinoma) families without detectable RET mutations. For these rare cases, the Mayo Clinic Endocrine Testing Unit should be consulted for additional information on the short calcium infusion test, including necessary precautions.
In completely cured cases following surgical therapy for MTC, serum calcitonin levels fall into the undetectable range over a variable period of several weeks. Persistently elevated postoperative serum calcitonin levels usually indicate incomplete cure. The reasons for this can be locoregional lymph node spread or distant metastases. In most of these cases, imaging procedures are required for further workup. Those individuals who are then found to suffer only locoregional spread may benefit from additional surgical procedures. However, the survival benefits derived from such approaches are still debated.
A rise in previously undetectable or very low postoperative serum calcitonin levels is highly suggestive of disease recurrence or spread, and should trigger further diagnostic evaluations.
Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
This test is not useful for evaluating calcium metabolic diseases.
Falsely elevated values may occur in serum from patients who have developed human antimouse antibodies or heterophilic antibodies.
Values obtained with different assay methods or kits may be different and cannot be used interchangeably. Test results cannot be interpreted as absolute evidence for the presence or absence of malignant disease.
Clinical Reference Provides recommendations for further in-depth reading of a clinical nature
1. Brandi ML, Gagel RF, Angeli A, et al: Guidelines for diagnosis and therapy of MEN type 1 and type 2. J Clin Endocrinol Metab 2001;86(12):5658-5671
2. Gimm O, Sutter T, Dralle H: Diagnosis and therapy of sporadic and familial medullary thyroid carcinoma. J Cancer Res Clin Oncol 2001;127(3):156-165
3. Perdrisot R, Bigorgne JC, Guilloteau D, Jallet P: Monoclonal immunoradiometric assay of calcitonin improves investigation of familial medullary thyroid carcinoma. Clin Chem 1990 February;36(2):381-383
4. Weissel M, Kainz H, Tyl E, et al: Clinical evaluation of new assays for determination of serum calcitonin concentration. ACTA Endocrinol (Copenh) 1991 May;124(5):540-544
Method Description Describes how the test is performed and provides a method-specific reference
The IMMULITE 2000 Calcitonin (CATN) assay is a solid-phase, 2-site chemiluminescence enzyme-labeled immunometric assay. The solid-phase bead is coated with monoclonal murine anticalcitonin. The serum specimen and alkaline phosphatase-conjugated goat polyclonal anticalcitonin antibody are incubated to bind calcitonin into an antibody sandwich complex. In the presence of alkaline phosphatase, the chemiluminescent substrate, which is a phosphate ester of adamantyl dioxetane, produces light that is proportional to the concentration of the calcitonin in the specimen.(Package insert: IMMULITE 2000 Calcitonin PIL2KCL-15, Siemens Medical Solutions Diagnostics, Los Angeles, CA, 2008-07-29)
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|