Recommendations

Document Overview

Design and created by Guideline Central in participation with the College of American Pathologists.

Principles of Analytic Validation of Immunohistochemical Assays

College of American Pathologists

Publication Date: Feb 23, 2024

Page Last Updated: May 6, 2026

Strength of Recommendations in GRADE

Document Overview

Document Title: Principles of Analytic Validation of Immunohistochemical Assays

Authoring Society: College of American Pathologists

Document Publication Date: Feb 23, 2024

Page Last Reviewed/Updated: May 6, 2026

Document Type: Guideline

Country of Publication: United States

Full Text Freely Available: Yes

Full Text Guideline: aplm.kglmeridian.com/view/journals/arpa/148/6/article-pe111.xml

Source Citation: Goldsmith JD, Troxell ML, Roy-Chowdhuri S, Colasacco CF, Edgerton ME, Fitzgibbons PL, Fulton R, Haas T, Kandalaft PL, Kalicanin T, Lacchetti C, Loykasek P, Thomas NE, Swanson PE, Bellizzi AM. Principles of Analytic Validation of Immunohistochemical Assays: Guideline Update. Arch Pathol Lab Med. 2024 Feb 23. doi: 10.5858/arpa.2023-0483-CP. Epub ahead of print. PMID: 38391878.

Supplemental Implementation Resources

Document Scope, Criteria, and Use Cases

Document Objectives: To develop recommendations for initial analytic validation and revalidation of immunohistochemical assays.

Scope: Assessment and Screening

Diseases/Conditions (MeSH)

D010338 - Pathology, Clinical

D010338 - Pathology, Clinical

Keywords: Assay validation, Immunohistochemical Assays

Inclusion Criteria: Male, Female, Adult

Health Care Settings: Hospital, Laboratory Services

Intended Users: Laboratory Technician, Nurse, Nurse Practitioner, Physician, Physician Assistant

Recommendation Development Processes & Methodology

Supplemental Methodology Resources: Data Supplement Methodology Supplement Data Supplement

Number of Source Documents: 185

Literature Search Start Date: Tuesday, April 9, 2019

Literature Search End Date: Monday, October 24, 2022

Includes peer/external review process?: Yes

Includes public comment process?: Yes

Methodologist involvement?: Yes

Patient involvement?: No

Includes multi-disciplinary group?: Yes

Includes systematic review?: Yes

Grades quality of strength of evidence?: Yes

Grades quality of strength of recommendation?: Yes

Discloses funding source?: Yes

Discloses conflicts of interest?: Yes

Includes benefits/harms analysis with recommendations?: No