Journal article
Principles of Analytic Validation of Immunohistochemical Assays: Guideline Update
Archives of pathology & laboratory medicine (1976), Vol.148(6), pp.e111-e153
02/23/2024
DOI: 10.5858/arpa.2023-0483-CP
PMID: 38391878
Abstract
In 2014, the College of American Pathologists developed an evidence-based guideline to address analytic validation of immunohistochemical assays. Fourteen recommendations were offered. Per the National Academy of Medicine standards for developing trustworthy guidelines, guidelines should be updated when new evidence suggests modifications.
To assess evidence published since the release of the original guideline and develop updated evidence-based recommendations.
The College of American Pathologists convened an expert panel to perform a systematic review of the literature and update the original guideline recommendations using the Grading of Recommendations Assessment, Development and Evaluation approach.
Two strong recommendations, 1 conditional recommendation, and 12 good practice statements are offered in this updated guideline. They address analytic validation or verification of predictive and nonpredictive assays, and recommended revalidation procedures following changes in assay conditions.
While many of the original guideline statements remain similar, new recommendations address analytic validation of assays with distinct scoring systems, such as programmed death receptor-1 and analytic verification of US Food and Drug Administration approved/cleared assays; more specific guidance is offered for validating immunohistochemistry performed on cytology specimens.
Details
- Title: Subtitle
- Principles of Analytic Validation of Immunohistochemical Assays: Guideline Update
- Creators
- Jeffrey D Goldsmith - From the Department of Pathology, Boston Children's Hospital and Harvard Medical School, Boston, Massachusetts (Goldsmith)Megan L Troxell - Stanford University School of MedicineSinchita Roy-Chowdhuri - The University of Texas MD Anderson Cancer CenterCarol F Colasacco - College of American PathologistsMary Elizabeth Edgerton - University of Nebraska Medical CenterPatrick L Fitzgibbons - St. Jude Medical CenterRegan Fulton - Array Science, LLC, Sausalito, California (Fulton)Thomas Haas - Seagull Laboratory Consulting, Janesville, Wisconsin (Haas)Patricia L Kandalaft - Pacific Pathology Partners, Seattle, Washington (Kandalaft)Tanja Kalicanin - College of American PathologistsChristina Lacchetti - Policy and Advocacy, American Society of Clinical Oncology, Alexandria, Virginia (Lacchetti)Patti Loykasek - Molecular, Immunohistochemistry and Flow Cytometry, Pathology Laboratory Associates, Tulsa, Oklahoma (Loykasek)Nicole E Thomas - College of American PathologistsPaul E Swanson - University of Washington Medical CenterAndrew M Bellizzi - University of Iowa
- Resource Type
- Journal article
- Publication Details
- Archives of pathology & laboratory medicine (1976), Vol.148(6), pp.e111-e153
- DOI
- 10.5858/arpa.2023-0483-CP
- PMID
- 38391878
- eISSN
- 1543-2165
- Language
- English
- Electronic publication date
- 02/23/2024
- Academic Unit
- Pathology
- Record Identifier
- 9984560487502771
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