HER2, Breast, Quantitative Immunohistochemistry, Automated
Testing Algorithm Delineates situation(s) when tests are added to the initial order. This includes reflex and additional tests.
Cases that are equivocal (2+) by immunohistochemical stain will reflex to HER2 FISH at an additional charge. Cases that are not able to be scanned for automated analysis due to technical issues will be changed to 89586 / HER2, Semi-Quantitative Immunohistochemistry, Manual for analysis.
Specimen Type Describes the specimen type needed for testing
Specimen Required Defines the optimal specimen. This field describes the type of specimen required to perform the test and the preferred volume to complete testing. The volume allows automated processing, fastest throughput and, when indicated, repeat or reflex testing.
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)
1. Submit paraffin-embedded invasive or metastatic breast carcinoma tissue.
2. 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.
3. Attach the green pathology address label included in the kit to the outside of the transport container.
1. Information regarding duration of fixation is required. When ordering this test, the following questions, as stated on the order form or presented electronically, must be answered:
-"Was specimen fixed in 10% neutral buffered formalin within 1 hour from surgical collection time? Yes, No, or Unknown."
-"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.
1. Pathology/Cytology Information (T707) in Special Instructions
2. 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)
Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.