HER2, Breast, Quantitative Immunohistochemistry, Automated
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: 2 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 (Supply 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.
Forms: If not ordering electronically, submit a Pathology Test Request Form (T246) with the specimen.
Specimen Minimum Volume Defines the amount of specimen required to perform an assay once, including instrument and container dead space. Submitting the minimum specimen volume makes it impossible to repeat the test or perform confirmatory or perform reflex testing. In some situations, a minimum specimen volume may result in a QNS (quantity not sufficient) result, requiring a second specimen to be collected.
Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.