Test Catalog

Test Id : TROP2

Trophoblast Antigen 2 (TROP2) Immunostain, Semi-Quantitative Immunohistochemistry, Manual

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

Identification of breast and urinary cancer, among others

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

Immunohistochemistry (IHC)

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

TROP2, SemiQuant IHC, Manual

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

TROP2

Specimen Type
Describes the specimen type validated for testing

Special

Shipping Instructions

Attach the green "Attention Pathology" address label (T498) to the outside of the transport container before putting into the courier mailer.

Necessary Information

A pathology/diagnostic report and a brief history are required.

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

Specimen Type: Tissue

Supplies: Pathology Packaging Kit (T554)

Collection Instructions: Formalin-fixed, paraffin-embedded tissue block; or 3 unstained glass, positively-charged slides with 4-microns formalin-fixed, paraffin-embedded tissue

Additional Information: One slide will be stained with hematoxylin and eosin and returned.

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

Wet/frozen tissue
Decalcified paraffin embedded tissue
Cytology smears
Non-formalin fixed tissue
Nonparaffin embedded tissue
Noncharged slides
ProbeOn slides
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
Special Ambient (preferred)
Refrigerated

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

Identification of breast and urinary cancer, among others

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

Trophoblast antigen 2 (TROP2) is overexpressed in many tissues and cancers, including breast and urinary cancer among others. An antibody drug conjugate, sacituzumab govitecan, targets the cell surface protein TROP2. Tumors with high expression of TROP2 are more likely to respond to targeted drug therapy.

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

Trophoblast antigen 2 is a membrane protein and immunohistochemical positivity is characterized by a membrane pattern of staining. Results are reported as percent positive cells and intensity of staining.

 

This result should be interpreted in the appropriate clinical context.

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 for nondecalcified paraffin-embedded tissue specimens fixed in 10% neutral-buffered formalin. Recommended fixation time is between 6 and 48 hours. This assay has not been validated on tissues subjected to the decalcification process or use of alternative fixatives for bone and bone marrow specimens or cell blocks.

 

Age of a cut paraffin section can affect immunoreactivity. Stability thresholds vary widely among published literature and are antigen dependent. Best practice is for paraffin sections to be cut within 6 weeks.

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

1. Shvartsu A, Bonavida B. Trop2 and its overexpression in cancers: regulation and clinical/therapeutic implications. Genes Cancer. 2015;6(3-4):84-105

2. Bardia A, Mayer I, Diamond J, et al. Efficacy and safety of anti-Trop-2 antibody drug conjugate sacituzumab govitecan (IMMU-132) in heavily pretreated patients with metastatic triple-negative breast cancer. J Clin Oncol. 2017;35:2141-2148

3. Lenart S, Lenart P, Smarda J, Remsik J, Souce K, Benes P. Trop2: Jack of all trades, master of none. Cancers. (Basel). 2020;12(11):3328. doi:10.3390/cancers12113328

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

Immunohistochemistry on sections of paraffin-embedded tissue.(Unpublished Mayo method)

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.

5 to 7 days

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

Until reported

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 account representative. 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 was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. It 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.

88360

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
TROP2 TROP2, SemiQuant IHC, Manual 105178-8
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.
621065 Interpretation 59465-5
621624 Participated in the Interpretation No LOINC Needed
621625 Report electronically signed by 19139-5
621626 Material Received 81178-6
621627 Disclaimer 62364-5
621628 Case Number 80398-1

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

Test Update Resources

Change Type Effective Date
New Test 2024-07-25