Test Catalog

Test Id : CATLN

Calcitonin, Fine-Needle Aspiration Biopsy Needle Wash, Lymph Node

Useful For
Suggests clinical disorders or settings where the test may be helpful

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

Highlights

Measurement of calcitonin in fine-needle aspiration biopsy (FNAB)-needle washes improves the evaluation of suspicious lymph nodes in patients with a history of medullary thyroid carcinoma (MTC) when used in combination with cytology.

 

Calcitonin in needle washes is particularly useful in cases where the cytology result is nondiagnostic or indeterminate.

 

In athyrotic patients with a history of MTC, a fine-needle aspiration calcitonin value of 5.0 pg/mL and higher is suggestive of the presence of metastatic MTC in the biopsied lymph node.

Method Name
A short description of the method used to perform the test

Electrochemiluminescence Immunoassay

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

Calcitonin, FNAB, Lymph Node

Specimen Type
Describes the specimen type validated for testing

Fine Needle Wash

Shipping Instructions

Send specimen frozen

Necessary Information

The biopsied site of each specimen is required and must be clearly identified in LIS and/or batch sheet.

ORDER QUESTIONS AND ANSWERS

Question ID Description Answers
SITEB Site

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

Patient Preparation: For 12 hours before this procedure do not take multivitamins or dietary supplements containing biotin (vitamin B7), which is commonly found in hair, skin, and nail supplements and multivitamins.

Collection Container/Tube: Plain, plastic, screw-top tube

Specimen Volume: 1 to 1.5 mL

Collection Instructions:

1. Needle wash specimens for analysis should be collected in conjunction with cytology specimens.

2. Have saline available prior to start of procedure. Saline is the only acceptable solution for needle washings.

3. After each fine-needle aspiration biopsy (FNAB) has been collected and the material in the needle has been expelled onto a slide for cytologic analysis, attach the used FNAB needle to an empty syringe.

4. Withdraw between 0.10 mL and 0.25 mL of saline up through the needle until the saline starts to fill the hub of the needle or end of the syringe.

5. Expel this fluid back through the needle into a separate tube. This is the needle washing used for analysis.

6. Repeat steps 2 through 4 for each needle pass of the same biopsied site and empty into the same tube, accumulating a total of 0.5 mL to 1.5 mL of fluid to send to the laboratory. (If more than 1 site is biopsied, see Additional Information)

7. Inspect specimen for visible blood or tissue contamination:

-a. If bloody, centrifuge specimen and transfer supernatant to a new plastic aliquot tube (5-mL standard tube) to send to laboratory. The supernatant, not the cellular material, is used for analysis.

-b. If specimen is clear, centrifugation is not necessary.

8. Freeze within 2 to 4 hours of collection.

Additional Information:

1. If more than 1 site is biopsied, each washing material should be submitted on a separate tube and under a different order number.

2. A minimum of 0.5 mL is required for testing; however, the total collection volume should not exceed 1.5 mL. Sample volumes outside these parameters may be rejected.

3. Do not send saline control. This test has been validated to rule-out saline matrix effect.

Forms

If not ordering electronically, complete, print, and send an Oncology Test Request (T729) with the specimen.

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

0.5 mL

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

Gross hemolysis Reject
Gross icterus OK

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

Specimen Type Temperature Time Special Container
Fine Needle Wash Frozen (preferred) 7 days
Refrigerated 4 hours

Useful For
Suggests clinical disorders or settings where the test may be helpful

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

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 less than 5% of all thyroid malignancies. Measurement of serum calcitonin is used in the follow-up of patients who underwent 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 (for a smear or CytoTrap preparation) has been expelled from the needle. 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.

Interpretation
Provides information to assist in interpretation of the test results

In athyrotic patients with a history of medullary thyroid carcinoma (MTC), a fine-needle aspiration calcitonin value of 5.0 pg/mL and greater is suggestive of the presence of metastatic MTC in the biopsied lymph node.

 

Calcitonin values less than 5.0 pg/mL suggest the lymph node does not contain medullary thyroid carcinoma. This result is dependent on accurate sampling and a total needle wash volume between 0.5 to 1.5 mL.

 

This test should be interpreted in the context of the clinical presentation, imaging, and cytology findings. If the results are discordant with the clinical presentation, a sampling error at the time of biopsy should be considered.

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 needle washing if serum calcitonin is significantly elevated. If blood was present in the washing, 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.

 

Samples should not be taken from patients receiving therapy with high biotin or vitamin B7 doses (ie, >5 mg/day) until at least 12 hours following the last biotin administration.

 

Results are dependent on accurate sampling and a maximum needle wash volume of 1.5 mL or less.

 

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.

Supportive Data

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 less than 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 greater than 30 pg/mL in 37% of cases. In 6% of cases, CATN was between 5 and 30 pg/mL.

Clinical Reference
Recommendations for 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, Takamura Y, Amino N, Hirokawa M: Diagnosis of medullary thyroid carcinoma by calcitonin measurement in fine-needle aspiration biopsy specimens. Thyroid. 2007 Jul;17(7):635-638

4. Trimboli P, D’Aurizio F, Tozzoli R, Giovanella L: Measurement of thyroglobulin, calcitonin, and PTH in FNA washout fluids. Clin Chem Lab Med. 2017 Jun;55(7):914-925

Method Description
Describes how the test is performed and provides a method-specific reference

The Roche human calcitonin (hCT) assay is a sandwich, electrochemiluminescence immunoassay that employs a biotinylated monoclonal hCT-specific antibody and a monoclonal hCT-specific antibody. Calcitonin in the specimen reacts with both the biotinylated monoclonal hCT-specific antibody and the monoclonal hCT-specific antibody labeled with a ruthenium complex, forming a sandwich complex. Streptavidin-coated microparticles are added and the mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode. Unbound substances are then removed with ProCell. Application of voltage to the electrode induces the chemiluminescent emission, which is then measured.(Package insert: Roche Elecsys Calcitonin, Roche Diagnostics; 07/2020)

 

For all samples with high concentrations of hCT, a dilution series is performed. A linear dilution excludes hooking and most major interferences. Samples that contain low hCT concentrations are spiked with exogenous hCT to identify possible interferences that may cause a false-low result.

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Monday through Friday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

1 to 3 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

12 months

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their Regional Manager. For assistance, contact Customer Service.

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 instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) 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. This test has not been cleared or approved by the US Food and Drug Administration.

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 Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

82308

LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

Test Id Test Order Name Order LOINC Value
CATLN Calcitonin, FNAB, Lymph Node 75709-6
Result Id Test Result Name Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
CATL Calcitonin, FNAB, Lymph Node 75709-6
SITEB Site 39111-0

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports