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Quantitative Image Analysis of HER2 Immunohistochemistry for Breast Cancer


The CAP’s evidence-based guideline Quantitative Image Analysis (QIA) Of HER2 Immunohistochemistry (IHC) For Breast Cancer, will soon be available as an early online release in the Archives of Pathology & Laboratory Medicine.

The interdisciplinary expert panel of pathologists, histotechnologists, and computer scientists with expertise in digital pathology (specifically image analysis), IHC, and quality management provide recommendations for improving reproducibility, precision, and accuracy in the interpretation of HER2 IHC for breast cancer performed by QIA.

This guideline aims to ensure accurate QIA diagnoses by answering these key questions:

  • What equipment validation and daily performance monitoring is needed?
  • What training of staff and pathologists is required? What are the competency assessments needs over time?
  • How does one select or develop an appropriate algorithm for interpretation?
  • How does one determine the performance of the image analysis?
  • How should image analysis be reported?

Guideline Resources

In Q2 2018, the CAP is expected to release this guideline. At that time, the following tools and resources will be available to help implement the guideline:

  • Summary Of Recommendations
  • Methodology Supplement (Supplemental Digital Content) 
  • Teaching Presentation
  •  Frequently Asked Questions
  • Infographic 
  • Change Documentation Log
  • List Of QIA Algorithms And Scanners
  • Technical Specifications

HER2 Tissue Donations

Donate laboratory tissue samples for the CAP proficiency testing programs. Contact the Purchasing team at mpspurc@cap.org.

Accreditation Requirements and Proficiency Testing (PT)

Accreditation checklist requirements regarding HER2 assay validation, specimen fixation, proficiency testing, and use of the ASCO/CAP scoring criteria for reporting results are included in the anatomic pathology (ANP), cytogenetics (CYG), and molecular pathology (MOL) checklists.

These checklists are available to CAP accredited laboratories through e-LAB Solutions Suite or can be purchased by non-CAP accredited laboratories.

Meet PT requirements by ordering the appropriate HER2 PT program. Call the CAP customer contact center at 1-800-323-4040 option 1#.

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