CAP Opens Updated Draft Guideline for Public Comment

Current guidance on proper IHC analytic validation helps assure accurate results for patients

NORTHFIELD, Ill.--(BUSINESS WIRE)--The College of American Pathologists is updating its 2014 evidence-based guideline “Principles of Analytic Validation of Immunohistochemical (IHC) Assays.” An expert panel has drafted updated recommendations, which are now open for comment from August 4-August 25, 2021.

All stakeholders—pathologists, histotechnologists, laboratory personnel, and quality managers—are encouraged to provide feedback on these draft recommendations.

“Updating the guideline is vital given that IHC testing is an essential component of the pathologic evaluation of many specimens. Moreover, the results increasingly provide key information that helps determine how patients are treated,” explains guideline chair Jeffrey D. Goldsmith, MD, FCAP. “Current guidance on proper analytic validation helps assure accurate results on patient samples.”

The updated draft guidance differs from the original guideline due to a change in methodology. Specifically, the CAP recently adopted the globally recognized evaluation method known as GRADE, for Grading of Recommendations Assessment, Development and Evaluation, which impacts how updated recommendations are now categorized.

As a result, the update affirms and expands on the original statements. Eleven of the original 14 recommendations are categorized as “Good Practice Statements,” which indicates a high level of certainty, but lack direct, published evidence.

Dr. Goldsmith led the expert panel of pathologists, histotechnologists, and a methodologist in the systematic review and evaluation of relevant literature published since the original guideline was issued. Following the open comment period, the panel will consider all feedback to finalize the recommendations, which will be formally published as an updated guideline.

To read and comment on the draft recommendations, visit cap.org between August 4-August 25, 2021.

About the College of American Pathologists

As the world's largest organization of board-certified pathologists and leading provider of laboratory accreditation and proficiency testing programs, the College of American Pathologists (CAP) serves patients, pathologists, and the public by fostering and advocating excellence in the practice of pathology and laboratory medicine worldwide. For more information, read the CAP annual report at CAP.ORG.