Test Catalog

Test Id : PTHFN

Parathyroid Hormone, Fine-Needle Aspiration Biopsy (FNAB)-Needle Wash

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

Discriminating thyroid tissue from enlarged parathyroid glands

 

Facilitating parathyroid localization prior to surgery

 

An adjunct to cytology examination of fine-needle aspiration specimens to confirm or exclude presence of parathyroid tissue in the biopsied area.

Highlights

Measurement of parathyroid hormone (PTH) in fine-needle aspiration biopsy (FNAB) washings could be used to discriminate thyroid tissues from enlarged parathyroid glands and also to facilitate parathyroid localization prior to surgery.

 

This test is best used as an adjunct to cytology examination to confirm or exclude the presence of parathyroid tissue in the biopsied area.

 

PTH values of 100 pg/mL and above are suggestive of the presence PTH-secreting tissue at the site biopsied or along the needle track.

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

PTH, FNAB, Needle Wash

Aliases
Lists additional common names for a test, as an aid in searching

PTH Needle Washout

Specimen Type
Describes the specimen type validated for testing

Fine Needle Wash

Shipping Instructions

Send specimen frozen to Mayo Clinic Laboratories for analysis.

Necessary Information

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

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 plastic aliquot 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.

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

1 to 1.5 mL

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

Gross hemolysis Reject
Gross icterus Reject

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) 30 days
Refrigerated 4 hours

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

Discriminating thyroid tissue from enlarged parathyroid glands

 

Facilitating parathyroid localization prior to surgery

 

An adjunct to cytology examination of fine-needle aspiration specimens to confirm or exclude presence of parathyroid tissue in the biopsied area.

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

Parathyroid hormone (PTH) is produced and secreted by the parathyroid glands, which are located along the posterior aspect of the thyroid gland. PTH analysis in rinse material obtained from fine-needle aspiration biopsies (FNAB) has gained popularity to discriminate thyroid tissues from enlarged parathyroid glands and to also facilitate parathyroid localization prior to surgery. Various groups have reported on the utility of this technique with specificity of 91% to100% and sensitivity of 82% to 100%. Measuring PTH in the rinse material proved to be very useful in cases of nondiagnostic cytology. Comparing the results of the PTH rinse material with serum PTH is highly recommended. An elevated PTH in the serum could falsely elevate PTH in the washings if the rinse is contaminated with blood. In these cases, only PTH values significantly higher than the serum should be considered as true positives.

 

Cytologic examination and measurement of PTH can be performed on the same specimen. To measure PTH, the fine-needle aspirate (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. Specimen collection is critical for the performance of the assay and the needle should be rinsed with a minimal volume. Each FNA needle from a single biopsied area is washed with 0.1 to 0.5 mL of normal saline. The washes from a single area are pooled (final volume 0.5-1.5 mL). PTH levels are measured in the saline 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

Parathyroid hormone (PTH) values less than 100 pg/mL suggest the biopsied site does not contain PTH-secreting tissue.

 

PTH values greater than or equal to 100 pg/mL are suggestive of the presence PTH-secreting tissue at the site biopsied or along the needle track. This result is dependent on accurate sampling and a total needle wash volume between 0.5 and 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 the biopsy should be considered.

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

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.

 

This test cannot distinguish between benign and malignant parathyroid tissue.

 

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 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.

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

1. Bancos I, Grant CS, Nadeem S, et al: Risks and benefits of parathyroid fine-needle aspiration with parathyroid hormone washout. Endocr Pract. 2012 Jul-Aug;18(4):441-449

2. Ketha H, Lasho MA, Algeciras-Schimnich A: Analytical and clinical validation of parathyroid hormone (PTH) measurement in fine-needle aspiration biopsy (FNAB) washings. Clin Biochem. 2016 Jan;49(1-2):16-21

3. 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 saline needle-wash specimen is analyzed with the Roche Diagnostics Elecsys PTH reagent. The Roche cobas assay for determining intact parathyroid hormone (PTH) employs a sandwich test principle in which a biotinylated monoclonal antibody reacts with the N-terminal fragment (1-37) and a monoclonal antibody labeled with a ruthenium complex(a) reacts with the C-terminal fragment (38-84). Application of a voltage to the electrode then induces chemiluminescent emission, which is measured by a photomultiplier. The antibodies used in this assay are reactive with epitopes in the amino acid regions 26-32 and 37-42.(Package insert: Roche Elecsys PTH, Roche Diagnostics; 12/2020)

 

For all samples with high concentrations of PTH, a dilution series is performed. A linear dilution excludes hooking and most major interferences. Samples that contain low PTH concentrations are spiked with exogenous PTH 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.

83970

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
PTHFN PTH, FNAB, Needle Wash 88106-0
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.
PTHF PTH, FNAB, Needle Wash 88106-0
SITEA 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