Home | About CytoJournalEditorial Board | Archived articles | Search CytoJ Articles | Subscribe | Peer review policies | CytoJournal Quiz Cases
  Reviewer corner | Author corner | OA Steward’s corner | CF member’s corner | Join as CF member | Manuscript submission | Open Access (OA) Advocacy
Home
CytoJournal All 'FULL TEXT' in HTML are FREE under "open access" charter of CytoJournal.
To login for downloading any PDF OR to request TOC (Table of Content) by e-mail, please click here
Home Email this page Print this page Small font size Default font size Increase font size Cytopathology Foundation
Navigate Here
 »   Next article
 »   Previous article
 »   Table of Contents

Resource Links
 »   Similar in PUBMED
 »  Search Pubmed for
 »  Search in Google Scholar for
 »Related articles
 »   Citation Manager
 »   Access Statistics
 »   Reader Comments
 »   Email Alert *
 »   Add to My List *
 * Requires registration (Free)
 

 Article Access Statistics
    Viewed1446    
    Printed30    
    Emailed0    
    PDF Downloaded4    
    Comments [Add]    

Recommend this journal

 

 METHODOLOGY ARTICLE
CytoJournal 2019,  16:6

Validation of immunohistochemical tests performed on cytology cell block material: Practical application of the College of American Pathologists' guidelines


1 Department of Pathology and Laboratory Medicine, East Carolina University, Greenville, NC, USA
2 Department of Pathology, Immunology and Laboratory Medicine, University of Florida College of Medicine, Gainesville, FL, USA

Correspondence Address:
F Zahra Aly
Department of Pathology, Immunology and Laboratory Medicine, University of Florida College of Medicine, Gainesville, FL
USA
Login to access the Email id

Source of Support: None, Conflict of Interest: None


DOI: 10.4103/cytojournal.cytojournal_29_18

Rights and Permissions

The advent of fiberoptic endoscopy with biopsy has revolutionized procurement of specimens from deep sites. This has translated into more cytologic specimens whereby the material is limited and best handled by cytology laboratory staff. While the diagnosis of the pathologic process is of utmost importance, there is increasing expectation that the diagnosis be specific and accurate as not to require additional biopsy for initiation of treatment. This expectation has driven demand in immunohistochemical (IHC) and molecular studies conducted specifically on material processed as cytology specimens. The Clinical Laboratory Improvement Amendments of 1988 requires laboratories in the United States of America to verify the performance of patient tests. Due to varying laboratory practices with respect to validation of IHC assays, the College of American Pathologists introduced guidelines for analytic validation of IHC tests. These guidelines address how to perform validation by recommending the number of cases in the validation set, comparator concordance, and when to revalidate. The main thrust of the guidelines is based on formalin-fixed paraffin-embedded tissue with only one expert consensus opinion referring to validation of IHC tests on cytology specimens which delegates to the medical director, the determination of number of positive and negative cases to be tested. This article will outline how an academic center approaches validation of IHC studies performed on cytology cell block specimens using the College of American Pathologists guidelines. A stepwise approach from selection of antibodies to validate followed by building the validation panel and evaluating the stain results for concordance against the gold standard of histology tissue specimen will be described. A rationale for dealing with discordant results and future innovations will conclude the report.






[FULL TEXT] [PDF]*


        
Print this article     Email this article

  Site Map | Copyright and Disclaimer
© 2007 - CytoJournal | A journal by Cytopathology Foundation Inc with Wolters Kluwer - Medknow
New version online since 1st July '08
Open Access