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 intil 25 August 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 Dr Jeffrey D Goldsmith 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The updated draft guidance differs from the original guideline due to a change in methodology.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, CAP recently adopted the globally recognised evaluation method known as GRADE (Grading of Recommendations Assessment, Development and Evaluation), which impacts how updated recommendations are now categorised.
As a result, the update affirms and expands on the original statements. Eleven of the original 14 recommendations are categorised 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 finalise the recommendations, which will be formally published as an updated guideline.
To read and comment on the draft recommendations, visit www.cap.org before 25 August 2021.