Test Id : HER2I
HER2 Immunostain, Technical Component Only
Useful For
Suggests clinical disorders or settings where the test may be helpful
Qualitative detection of HER2 protein overexpression in a diagnostic setting in formalin-fixed paraffin-embedded tissue sections
Reflex Tests
Lists tests that may or may not be performed, at an additional charge, depending on the result and interpretation of the initial tests.
| Test Id | Reporting Name | Available Separately | Always Performed |
|---|---|---|---|
| IHTOI | IHC Initial, Tech Only | No | No |
| IHTOA | IHC Additional, Tech Only | No | No |
Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.
For the initial technical component only immunohistochemical (IHC) stain performed, the appropriate bill-only test ID will be reflexed and charged (IHTOI). For each additional technical component only IHC stain performed, an additional bill-only test ID will be reflexed and charged (IHTOA).
Method Name
A short description of the method used to perform the test
Immunohistochemistry
NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.
Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test
Aliases
Lists additional common names for a test, as an aid in searching
ISHER2IIHCTO
Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.
For the initial technical component only immunohistochemical (IHC) stain performed, the appropriate bill-only test ID will be reflexed and charged (IHTOI). For each additional technical component only IHC stain performed, an additional bill-only test ID will be reflexed and charged (IHTOA).
Specimen Type
Describes the specimen type validated for testing
TECHONLY
Ordering Guidance
This test includes only technical performance of the stain (no pathologist interpretation is performed).
This test provides qualitative results only. For semiquantitative assessment of HER2 as a predictive or prognostic marker in the setting of breast cancer, order HERBA / HER2, Breast, Quantitative Immunohistochemistry, Automated with HER2 FISH Reflex or in the setting of gastric esophageal tissues, order HERGM / HER2, Gastric/Esophageal, Semi-Quantitative Immunohistochemistry, Manual and return Mayo-stained tech only HER2 slide along with hematoxylin and eosin-stained slide, or block and 2 unstained slides.
For immunostain detection of HER2 for diagnostic purposes, order HER2I / HER2 Immunostain, Technical Component Only.
For immunostain detection of HER2 in invasive or metastatic breast primary specimens with interpretation and reflex fluorescence in situ hybridization (FISH) testing, order HERMB / HER2, Breast, Semi-Quantitative Immunohistochemistry, Manual with HER2 FISH Reflex.
For immunostain detection of HER2 in invasive or metastatic gastroesophageal adenocarcinoma primary specimens with interpretation and reflex FISH testing, order HERGM / HER2, Gastric/Esophageal, Semi-Quantitative Immunohistochemistry, Manual.
For immunostain detection of HER2 in invasive or metastatic gastroesophageal adenocarcinoma primary with interpretation but without reflex FISH testing, order HERGN / HER2, Gastric/Esophageal, Semi-Quantitative Immunohistochemistry, Manual, No Reflex.
For immunostain detection of HER2 in invasive or metastatic solid tumors with interpretation and without reflex FISH testing, order HERST / HER, Solid Tumor, Semi-Quantitative Immunohistochemistry, Manual.
For FISH HER2 testing in invasive or metastatic breast primary specimens with interpretation, order H2BR / HER2 Amplification Associated with Breast Cancer, FISH, Tissue.
For FISH HER2 testing in invasive or metastatic primary gastroesophageal specimens with interpretation, order H2GE / HER2 Amplification Associated with Gastroesophageal Cancer, FISH, Tissue.
For FISH HER2 testing in primary or metastatic tumor specimens which are not breast or gastroesophageal primary, order H2MT / HER2 Amplification, Miscellaneous Tumor, FISH, Tissue.
For interpretation and diagnosis of submitted pathology specimens with appropriate additional stains and other ancillary testing, order PATHC / Pathology Consultation.
Additional material may be needed if alternative testing is requested. See the specific specimen requirements for the alternative requested testing.
Shipping Instructions
Attach the green "Attention Pathology" address label (T498) and the pink Immunostain Technical Only label included in the kit to the outside of the transport container.
Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing
Specimen Type: Tissue
Supplies: Immunostain Technical Only Envelope (T693)
Container/Tube: Immunostain Technical Only Envelope
Submit:
-Formalin-fixed, paraffin-embedded tissue block
OR
-2 Unstained, positively charged glass slides (25- x 75- x 1-mm) per test ordered; sections 4-microns thick
Digital Image Access
1. Information on accessing digital images of immunohistochemical (IHC) stains and the manual requisition form can be accessed through this website: https://news.mayocliniclabs.com/pathology/digital-imaging/
2. Clients ordering stains using a manual requisition form will not have access to digital images.
3. Clients wishing to access digital images must place the order for IHC stains electronically. Information regarding digital imaging can be accessed through this website: https://news.mayocliniclabs.com/pathology/digital-imaging/#section3
Forms
If not ordering electronically, complete, print, and send a Immunohistochemical (IHC)/In Situ Hybridization (ISH) Stains Request (T763) with the specimen.
Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected
| Wet/frozen tissue Cytology smears Nonformalin fixed tissue Nonparaffin embedded tissue Noncharged slides ProbeOn slides Snowcoat 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 |
|---|---|---|---|
| TECHONLY | Ambient (preferred) | ||
| Refrigerated | |||
Useful For
Suggests clinical disorders or settings where the test may be helpful
Qualitative detection of HER2 protein overexpression in a diagnostic setting in formalin-fixed paraffin-embedded tissue sections
Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.
For the initial technical component only immunohistochemical (IHC) stain performed, the appropriate bill-only test ID will be reflexed and charged (IHTOI). For each additional technical component only IHC stain performed, an additional bill-only test ID will be reflexed and charged (IHTOA).
Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
The human HER2 gene (also known as ERBB2 or NEU) encodes a protein often referred to as HER2 protein or P185(HER2). The HER2 protein is a membrane receptor tyrosine kinase with homology to the epidermal growth factor receptor (EGFR or HER1). The HER2 protein is a normal component expressed by a variety of epithelial cell types.
Interpretation
Provides information to assist in interpretation of the test results
This test does not include pathologist interpretation, only technical performance of the stain.
The positive and negative controls are verified as showing appropriate immunoreactivity and documentation is retained at Mayo Clinic Rochester.
Interpretation of this test should be performed in the context of the patient's clinical history and other diagnostic tests by a qualified pathologist.
Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
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.
The charge of glass slides can be affected by environmental factors and subsequently may alter slide staining. Sending unsuitable glass slides can result in inconsistent staining due to poor slide surface chemistry.
Best practices for storage of positively charged slides:
-Minimize time slides are stored after being unpackaged
-Limit exposure to high humidity and heat
-Minimize exposure to plastics
Clinical Reference
Recommendations for in-depth reading of a clinical nature
1. Calhoun BC, Collins LC. Predictive markers in breast cancer: an update on ER and HER2 testing and reporting. Semin Diagn Pathol. 2015;32(5):362-369. doi:10.1053/j.semdp.2015.02.011
2. Bahreini F, Soltanian AR, Mehdipour P. A meta-analysis on concordance between immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH) to detect HER2 gene overexpression in breast cancer. Breast Cancer. 2015;22(6):615-625. doi:10.1007/s12282-014-0528-0
3. Wolff AC, Hammond EH, Hicks DG, et al. Recommendations for human epidermal growth factor receptor 2 testing in breast cancer: American Society of Clinical Oncology/College of American Pathologists clinical practice guideline update. J Clin Oncol. 2013;31(31):3997-4013. doi:10.1200/JCO.2013.50.9984
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
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.
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
Indicates the location of the laboratory that performs the test
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 has been cleared, approved, or is exempt by the US Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified 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 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.
CPT codes are provided by the performing laboratory.
88342-TC, Primary
88341-TC, If additional IHC
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 |
|---|---|---|
| HER2I | HER2 IHC, Tech Only | Order only;no result |
| 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.
|
|---|---|---|
| 70770 | HER2 IHC, Tech Only | Bill only; no result |