Test Catalog

Test Id : TFNAB

Thyroglobulin, Tumor Marker, Fine-Needle Aspiration Biopsy Needle Wash

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

Confirming or excluding metastases in enlarged or ultrasonographically suspicious lymph nodes from athyrotic individuals treated for differentiated thyroid cancer in conjunction with cytologic analysis

 

Confirming or excluding the presence of thyroid tissue in the biopsied area from athyrotic individuals treated for differentiated thyroid cancer in conjunction with cytologic analysis

 

This test is not useful for screening asymptomatic individuals for neoplastic disease.

Highlights

-Measurement of thyroglobulin in fine-needle aspiration biopsy (FNAB) needle washes improves the evaluation of suspicious lymph nodes in athyrotic patients suspected of metastatic differentiated follicular cell-derived thyroid carcinoma.

-Measurement of thyroglobulin is particularly useful in cases where the cytology result is not diagnostic or indeterminate.

-Interpretation of thyroglobulin concentrations in FNAB-needle washes from tissues other than lymph nodes is less well defined.

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

Immunoenzymatic Assay

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

Thyroglobulin, FNAB Needle Wash

Specimen Type
Describes the specimen type validated for testing

Fine Needle Wash

Necessary Information

The biopsied site of each specimen must be identified as from a lymph node or non-lymph node source, and the specific biopsy site must be clearly identified in LIS or on batch sheet.

ORDER QUESTIONS AND ANSWERS

Question ID Description Answers
TFNA6 Lymph Node (LN) or Non-LN Source
TFNA7 Site Location

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

Patient Preparation: For 12 hours before specimen collection 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 plastic screw-top 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. Refrigerate within 1 to 2 hours of collection. Send specimen frozen (preferred) or refrigerate.

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. Specimen volumes outside these parameters may be rejected.

3. Do not send a 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) 90 days
Refrigerated 14 days
Ambient 7 days

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

Confirming or excluding metastases in enlarged or ultrasonographically suspicious lymph nodes from athyrotic individuals treated for differentiated thyroid cancer in conjunction with cytologic analysis

 

Confirming or excluding the presence of thyroid tissue in the biopsied area from athyrotic individuals treated for differentiated thyroid cancer in conjunction with cytologic analysis

 

This test is not useful for screening asymptomatic individuals for neoplastic disease.

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

Thyroglobulin (Tg) is a 660,000 Da glycoprotein produced exclusively by the follicular cells of the thyroid. Given the tissue specificity of Tg production, measurement of serum concentrations in athyrotic patients enables detection of persistence, recurrence, or metastasis of differentiated thyroid carcinoma. In addition, Tg measurement in biopsy specimens of nonthyroidal tissues may assist in confirming and localizing metastatic disease.

 

In papillary thyroid carcinoma (PTC), which accounts for greater than 80% of all thyroid cancer cases, most metastatic disease occurs in loco-regional lymph nodes in the neck, which are easily examined by ultrasound. Most suspicious nodes undergo ultrasonography-guided fine-needle aspiration biopsy (FNAB) for cytology examination to determine a diagnosis. Unfortunately, in up to 20% of cases, inadequate cellularity or nonrepresentative sampling precludes the diagnosis. Measurement of Tg in FNAB washes from lymph nodes suspected of metastatic PTC is used as an adjunct to cytology examination after ultrasound-guided FNAB in situations where cytology is inconclusive. One of the advantages of the measurement of Tg in FNAB washes is that a dedicated needle pass is not necessary for analysis. Most often, the washout is performed by rinsing the FNAB needle with a small volume of saline immediately after the cellular component of the biopsy has been expelled for cytological examination.

 

The diagnostic performance of Tg in FNAB washouts often allows for the accurate diagnosis of cases in which cytology is non-diagnostic. A meta-analysis that included 24 studies and 2865 lymph nodes reported a pooled sensitivity of 95% and specificity of 94% for detection of metastatic PTC. The diagnostic performance of Tg in FNAB washes is superior in athyrotic patients. In studies that included patients with the thyroid gland, the sensitivity was 86.2% and specificity was 90.2%. Including only patients after thyroidectomy showed improved performance with a sensitivity of 96.9% and specificity of 94.1%. In an in-house study, a Tg cut-off of 1 ng/mL for FNAB-needle wash specimens provided 100% sensitivity and 96.2% specificity for the detection of metastatic thyroid carcinoma in lymph nodes from athyrotic patients. The diagnostic performance of Tg at the 1-ng/mL cut-off compared favorably with cytology (95.1% overall agreement) and allowed accurate diagnosis in 18 of the 19 cases in which cytology was nondiagnostic or not performed. A number of professional guidelines recommend the measurement of Tg in FNAB washouts from lymph nodes in cases of inadequate cytology or cases with conflicting cytological and ultrasound evaluations.

 

Interpretation of Tg concentrations in FNAB needle washes from tissues other than lymph nodes is not well defined and needs to be considered in the case by case basis. The most established use is to determine the tissue origin of a thyroid mass/nodule or other neck mass/nodule that is suspected to be thyroid derived. This can be accomplished by measuring Tg, calcitonin and parathyroid hormone in the lesion. Measurement of Tg in thyroid bed tissue in patients, who underwent total thyroidectomy and radioactive iodine ablation, is a relatively frequent application of Tg testing, and may differentiate scar tissue from residual normal thyroid tissue. Finally, occasionally lesions in other organs might be biopsied to determine by Tg measurement if they are thyroid derived, if cytology/histology in not informative.

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.

Lymph node: < or =1.0 ng/mL

This cutoff has been validated for total needle wash volumes of < or =1.5 mL of normal saline. If wash volumes are substantially larger, a lower cutoff might apply.

Non Lymph node: an interpretation will be provided

Interpretation
Provides information to assist in interpretation of the test results

Lymph Nodes:

In athyrotic patients with a history of differentiated thyroid carcinoma, thyroglobulin (Tg) concentration greater than 1.0 ng/mL in the fine-needle aspiration biopsy (FNAB) needle wash suggests the presence of metastatic differentiated follicular cell-derived thyroid carcinoma in the biopsied area.

 

Tg measurements yield reliable results in most cases with nondiagnostic cytology and are approximately equal in diagnostic accuracy to cytological examinations that are deemed sufficient for diagnosis.

 

Non-lymph nodes:

When measuring Tg in FNAB needle washes from thyroid bed tissue after total thyroidectomy and radioactive iodine ablation to differentiate thyroid versus scar tissue, an undetectable Tg concentration will be consistent with the absence of thyroid-derived tissue (including thyroid carcinoma) at the site biopsied. Detectable Tg concentration is consistent of the presence of thyroid-derived tissue, but it is not indicative of the presence of malignancy.

 

Measurement of Tg in FNAB needle washes from a thyroid nodule may be used to distinguish parathyroid versus follicular cell derived and C-cell derived thyroid tissue but cannot identify a malignant process in the nodule.

 

For all other biopsied sites, eg, lung, kidney, liver, brain, bone, and various other sites, absence of measurable Tg in FNAB needle washes is consistent with the absence of thyroid-derived tissue (including thyroid carcinoma) at the site biopsied. A detectable Tg concentration is consistent of the presence of thyroid-derived tissue, but it is not necessarily indicative of the presence of malignancy.

Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

This test has been validated only in single lymph nodes from athyrotic patients. While the needle washes from several distinct needle passes or aspirations from a single node should be pooled, biopsies from different nodes or other sites such as thyroid bed should be submitted as separate specimens.

 

Do not interpret fine-needle aspiration biopsy (FNAB) - thyroglobulin (Tg) levels as absolute evidence of the presence or absence of malignant disease. Results should be used in conjunction with information from the clinical evaluation of the patient, cytology, and imaging procedures.

 

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. While autoantibody interference (typically false-low results in immunometric assays) is reported to not be an issue for FNAB-needle wash specimens, the report was based on a small number of cases; therefore, the possibility of autoantibody interference should also be considered.

 

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

 

FNAB needle wash results should always be interpreted in the context of systemic circulating serum Tg concentrations, particularly in cases where the needle wash is visibly blood contaminated.

Clinical Reference
Recommendations for in-depth reading of a clinical nature

1. Grani G, Fumarola A: Thyroglobulin in lymph node fine-needle aspiration washout: a systematic review and meta-analysis of diagnostic accuracy. J Clin Endocrinol Metab. 2014;99(6):1970-1982

2. Snozek CL, Chambers EP, Reading CC, et al: Serum thyroglobulin, high-resolution ultrasound, and lymph node thyroglobulin in diagnosis of differentiated thyroid carcinoma nodal metastases. J Clin Endocrinol Metab. 2007;92(11):4278-4281

3. Algeciras-Schimnich A: Thyroglobulin measurement in the management of patients with differentiated thyroid cancer. Crit Rev Clin Lab Sci. 2018 May;55(3):205-218

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

Testing is performed using the Beckman Access thyroglobulin (Tg) assay, a simultaneous 1-step immunoenzymatic (sandwich) assay performed on the Beckman Coulter UniCel DxI 800. A sample is added to a reaction vessel along with a biotinylated mixture of 4 mouse monoclonal anti-Tg antibodies, streptavidin-coated paramagnetic particles, and mouse monoclonal anti-Tg antibody-alkaline phosphatase conjugate. The biotinylated antibodies and the sample Tg bind to the solid phase, while the conjugate antibody reacts with a different antigenic site on the Tg molecule. After incubation in a reaction vessel, materials bound to the solid phase are held in a magnetic field, while unbound materials are washed away. The chemiluminescent substrate Lumi-Phos530 is added to the vessel and light generated by the reaction is measured with a luminometer. Light production is directly proportional to the concentration of Tg in the sample. The amount of analyte in the sample is determined from a stored, multipoint calibration curve.(Instruction manual: Access Thyroglobulin Assay. Beckman Coulter, Inc; 2019)

 

For all samples with Tg concentrations greater than 1.0 ng/mL, a dilution series is performed. A linear dilution excludes hooking and most major interferences. Samples that contain Tg of 1.0 ng/mL or less are spiked with exogenous Tg 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.

84432

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
TFNAB Thyroglobulin, FNAB Needle Wash 53922-1
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.
TFNA3 Thyroglobulin, FNAB, Lymph Node 53920-5
TFNA4 Thyroglobulin, FNAB, Non Lymph Node 53922-1
TFNA5 Thyroglobulin, FNAB, Interpretation 69053-7
TFNA6 Lymph Node (LN) or Non-LN Source 31208-2
TFNA7 Site Location 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