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Test Code HERBA HER2, Breast, Quantitative Immunohistochemistry, Automated with HER2 FISH Reflex


Shipping Instructions


Attach the green pathology address label included in the kit to the outside of the transport container.



Necessary Information


1. Include accompanying pathology report stating the final diagnosis. If not available, a preliminary diagnosis is acceptable only if it refers to invasive or metastatic breast carcinoma.

2. Information regarding duration of fixation is required.



Specimen Required


Supplies: Pathology Packaging Kit (T554)

Specimen Type:

Preferred: A paraffin-embedded tissue block containing breast cancer tissue that has been fixed in 10% neutral buffered formalin within 1 hour from surgical collection time and for a total of 6 to 72 hours and shipped at ambient temperature

Acceptable: 5 unstained sections containing breast carcinoma on charged slides cut at 4 microns <1 month ago and shipped at ambient temperature. Tissue on the slides should have been fixed in 10% neutral buffered formalin within 1 hour from surgical collection time and for a total of 6 to 72 hours.

Container/Tube: Pathology Packaging Kit (T554)

Collection Instructions: Submit paraffin-embedded invasive or metastatic breast carcinoma tissue.

Additional Information:

1. When ordering this test, the following questions, as stated on the order form or presented electronically, must be answered:

a. "Was specimen fixed in 10% neutral buffered formalin within 1 hour from surgical collection time? Yes, No, or Unknown."

b. "Has specimen been fixed in 10% neutral buffered formalin for 6 to 72 hours? Yes, No, or Unknown."

2. According to the College of American Pathologists (CAP)/American Society of Clinical Oncology (ASCO) guidelines, HER2 protein immunohistochemical test results are only valid for nondecalcified, paraffin-embedded specimens fixed in 10% neutral buffered formalin within 1 hour from surgical collection time and for a total time of 6 to 72 hours. Under- or overfixation may affect these results.

3. HER2 immunohistochemistry testing on intracystic papillary carcinoma and solid papillary carcinoma, without clearly stating invasive carcinoma, is not appropriate and will be canceled without processing.

4. Paraffin blocks will be returned with final report.


Forms

If not ordering electronically, complete, print, and send 1 of the following forms with the specimen:

Pathology Test Request Form (T246) (http://www.mayomedicallaboratories.com/it-mmfiles/pathology-request-form.pdf)

Oncology Test Request Form (T729) (http://www.mayomedicallaboratories.com/it-mmfiles/oncology-request-form.pdf)

Immunohistochemical (IHC)/In Situ Hybridization (ISH) Stains Request Form (T763) (http://www.mayomedicallaboratories.com/it-mmfiles/ihc-and-ish-stain-request-form-mc0767-09a.pdf)

Useful For

Determining overexpression of HER2 protein on formalin-fixed, paraffin-embedded tissue sections using automated quantitative immunohistochemistry

Reflex Tests

Test ID Reporting Name Available Separately Always Performed
HER2F HER2, Breast Tumor, FISH, Ts Yes No
HERBM HER Breast Semi Quant IHC Manual No No

Testing Algorithm

Cases that are equivocal (2+) by immunohistochemical stain will reflex to HER2 amplification by FISH at an additional charge. Cases that are not able to be scanned for automated analysis due to technical issues will be changed to the manual process for analysis.

Method Name

Ventana Pathway Immunoperoxidase Stain with Automated Quantitative Immunohistochemistry

Reporting Name

HER Breast IHC Automated + Reflex

Specimen Type

Special

Specimen Stability Information

Specimen Type Temperature Time
Special Ambient (preferred)
  Refrigerated 

Reject Due To

Hemolysis

NA

Lipemia

NA

Icterus

NA

Other

NA

Reference Values

Reported as negative (0, 1+), equivocal (2+), and strongly positive (3+) according to the interpretation guidelines for the FDA-approved Ventana Pathway HER2 (4B5) antibody.

Day(s) and Time(s) Performed

Monday through Friday

Analytic Time

2 days (HER2 IHC only); 8 days (if HER2F is added on)

Performing Laboratory

Mayo Medical Laboratories in Rochester

Test Classification

This test has been cleared or approved by the U.S. 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

88361

LOINC Code Information

Test ID Test Order Name Order LOINC Value
HERBA HER Breast IHC Automated + Reflex In Process

 

Result ID Test Result Name Result LOINC Value
70970 Interpretation 50595-8
70971 Participated in the Interpretation No LOINC Needed
70972 Report electronically signed by 19139-5
70974 Material Received 81178-6
MA007 Fixed in 10% NB formalin w/in 1 hr In Process
MA008 Fixed in 10% NB formalin 6-72 hrs In Process
MA009 Tumor type In Process
MA010 Tumor classification In Process
71621 Disclaimer 62364-5
71835 Case Number In Process