Principles of Analytic Validation of Immunohistochemical Assays: Guideline Update

Author:

Goldsmith Jeffrey D.1,Troxell Megan L.2,Roy-Chowdhuri Sinchita3,Colasacco Carol F.4,Edgerton Mary Elizabeth5,Fitzgibbons Patrick L.6,Fulton Regan7,Haas Thomas8,Kandalaft Patricia L.9,Kalicanin Tanja4,Lacchetti Christina10,Loykasek Patti11,Thomas Nicole E.4,Swanson Paul E.12,Bellizzi Andrew M.13

Affiliation:

1. From the Department of Pathology, Boston Children’s Hospital and Harvard Medical School, Boston, Massachusetts (Goldsmith)

2. the Department of Pathology, Stanford University School of Medicine, Stanford, California (Troxell)

3. the Department of Pathology, The University of Texas MD Anderson Cancer Center, Houston, Texas (Roy-Chowdhuri)

4. the Pathology and Laboratory Quality Center for Evidence-based Guidelines, College of American Pathologists, Northfield, Illinois (Colasacco, Kalicanin, Thomas)

5. the Department of Pathology and Microbiology, University of Nebraska Medical Center, Omaha, Nebraska (Edgerton)

6. the Department of Pathology, Providence St Jude Medical Center, Fullerton, California (Fitzgibbons)

7. Array Science, LLC, Sausalito, California (Fulton)

8. Seagull Laboratory Consulting, Janesville, Wisconsin (Haas)

9. Pacific Pathology Partners, Seattle, Washington (Kandalaft)

10. Policy and Advocacy, American Society of Clinical Oncology, Alexandria, Virginia (Lacchetti)

11. Molecular, Immunohistochemistry and Flow Cytometry, Pathology Laboratory Associates, Tulsa, Oklahoma (Loykasek)

12. the Department of Laboratory Medicine and Pathology, University of Washington Medical Center, Seattle, Washington (Swanson)

13. the Department of Pathology, University of Iowa Hospitals and Clinics, Iowa City, Iowa (Bellizzi)

Abstract

Context.— 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. Objective.— To assess evidence published since the release of the original guideline and develop updated evidence-based recommendations. Design.— 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. Results.— 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. Conclusions.— 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.

Publisher

Archives of Pathology and Laboratory Medicine

Reference185 articles.

1. Principles of analytic validation of immunohistochemical assays: guideline from the College of American Pathologists Pathology and Laboratory Quality Center;Fitzgibbons;Arch Pathol Lab Med,2014

2. Analytic validation of immunohistochemical assays: a comparison of laboratory practices before and after introduction of an evidence-based guideline;Fitzgibbons;Arch Pathol Lab Med,2017

3. Clinical Practice Guidelines We Can Trust

4. Clinical laboratory improvement amendments of 1988: final rule;US Department of Health and Human Services;Fed Regist,1992

5. PROSPERO: international prospective register of systematic reviews;National Institute for Health and Care Research

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