Calcitonin, Fine-Needle Aspiration Biopsy (FNAB)-Needle Wash, Lymph Node
NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
As an adjunct to cytologic examination of fine-needle aspiration specimens in athyrotic individuals treated for medullary thyroid carcinoma to confirm or exclude metastases in enlarged or ultrasonographically suspicious lymph nodes
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
Calcitonin, FNAB, Lymph Node
Specimen Type Describes the specimen type needed for testing
Fine Needle Wash
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.
Container/Tube: Plain, plastic, screw-top tube
Specimen Volume: 1.5 mL
Collection Instructions: After collection of the cytology specimens and expulsion of the material for smear or CytoTrap, process as follows:
1. Wash/rinse each FNA needle from a single biopsied area with 0.1 to 0.5 mL of normal saline.
2. Pool each wash from a single biopsied area into 1 vial. The washes from a biopsied area are pooled (final volume 1-1.5 mL). If more than 1 area is biopsied, each biopsy area should be submitted as a separate specimen, under a separate order.
3. Inspect the specimen as follows:
a. If the specimen shows visible blood or tissue contamination, centrifuge the specimen, transfer the supernatant to a new plastic vial, and freeze.
b. If specimen is clear, freeze specimen in plastic vial.
c. Specimen should be frozen within 2 to 4 hours of collection.
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.
1 mL (Samples <1 mL may be rejected)
Mild OK; Gross reject
Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.
|Fine Needle Wash||Frozen (preferred)||7 days|
Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
Calcitonin is a polypeptide hormone secreted by the parafollicular cells (also referred to as calcitonin cells or C-cells) of the thyroid gland. 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. Measurement of serum calcitonin is used in the follow-up of patients that have surgical removal of the thyroid gland.
Studies have reported that the measurement of calcitonin in fine-needle aspiration biopsy (FNAB)-needle washes improves the evaluation of suspicious lymph nodes in patients with a history of MTC when used in combination with cytology. Comparing the results of calcitonin in the needle rinse with serum calcitonin is highly recommended. An elevated calcitonin in the serum could falsely elevate calcitonin in the washings, if the rinse is contaminated with blood. In these cases only calcitonin values significantly higher than the serum should be considered as true positives.
Cytologic examination and measurement of calcitonin can be performed on the same specimen. To measure calcitonin, the FNA needle is rinsed with a small volume of normal saline solution immediately after a specimen for cytological examination has been expelled from the needle for a smear or CytoTrap preparation. Calcitonin levels are measured in the needle wash.
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.
An interpretive report will be provided.
In athyrotic patients with a history of medullary thyroid carcinoma (MTC), a fine-needle aspiration calcitonin value > or =5.0 pg/mL is suggestive of the presence of metastatic MTC in the biopsied lymph node.
Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
Blood contamination during the biopsy might lead to false elevations of calcitonin in the fine-needle aspiration biopsy washout if serum calcitonin is significantly elevated. If blood was present in the washout, only calcitonin values significantly higher than the serum should be considered as true positives.
Immunometric assays can, in rare occasions, be subject to interferences such as "hooking" at very high analyte concentrations (false-low results) and heterophilic antibody interference (false-high results). If the clinical picture does not fit the laboratory result, these possibilities should be considered.
Results are dependent on accurate sampling and a maximum needle wash volume of < or =1.5 mL.
While the needle washes from several distinct needle passes or aspirations from a single area should be pooled, biopsies from different areas should be submitted as separate specimens.
Eighty-one lymph node washings were analyzed for calcitonin and thyroglobulin (as an indicator of the presence of metastatic thyroid tissue). All lymph node washings had a calcitonin value <5.0 pg/mL. A retrospective analysis of calcitonin (CATN) fine-needle aspiration (FNA) washings ordered clinically between 2008 and 2011 was performed. There were 65 samples in which the source was identified as lymph node. Calcitonin was undetectable (<5.0 pg/mL) in 57% of cases and >30 pg/mL in 37% of cases. In 6% of cases CATN was between 5 and 30 pg/mL.
Clinical Reference Provides recommendations for further in-depth reading of a clinical nature
1. Trimboli P, Rossi F, Baldelli R, et al: Measuring calcitonin in washout of the needle in patients undergoing fine needle aspiration with suspicious medullary thyroid cancer. Diagn Cytopathol 2012 May;40(5):394-398
2. Boi F, Maurelli I, Pinna G, et al: Calcitonin measurement in wash-out fluid from fine needle aspiration of neck masses in patients with primary and metastatic medullary thyroid carcinoma. J Clin Endocrinol Metab 2007 Jun;92(6):2115-2118
3. Kudo T, Miyauchi A, Ito Y, et al: Diagnosis of medullary thyroid carcinoma by calcitonin measurement in fine-needle aspiration biopsy specimens. Thyroid 2007 Jul;17(7):635-638
Method Description Describes how the test is performed and provides a method-specific reference
The saline needle-wash specimen is analyzed with the Siemens calcitonin reagent assay on the Siemens Immulite 1000. The Siemens calcitonin assay is a solid-phase, 2-site chemiluminescence enzyme-labeled immunometric assay. The solid-phase bead is coated with monoclonal murine anticalcitonin. The 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, Siemens Medical Solutions Diagnostics, Los Angeles, CA. PIL2KCL-15, 2008-07-29)
For all samples with calcitonin concentrations >50 pg/mL, a dilution series is performed. A linear dilution excludes hooking and most major interferences. Samples that contain calcitonin concentrations <50 pg/mL are spiked with exogenous calcitonin to identify possible interferences that may cause a false-low result.
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; Varies
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 modified from the manufacturer’s instructions. Its performance characteristics were determined 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|
|CATL||Calcitonin, FNAB, Lymph Node||In Process|