Document Detail

Adjunctive HPV In-Situ Hybridization (ISH) Assay as an Aid in the Diagnosis of Cervical Intraepithelial Neoplasia in Cervical Tissue Specimens: An Analytical and Functional Characterization.
MedLine Citation:
PMID:  23018222     Owner:  NLM     Status:  Publisher    
The purpose of this study was to develop and analytically and functionally validate a new human papillomavirus (HPV) in-situ hybridization (ISH) assay and to determine whether the use of this assay combined with hemotoxylin and eosin (H&E) staining could potentially improve the diagnostic accuracy of interpreting cervical intraepithelial neoplasia (CIN) in human cervical tissue specimens. An automated HPV ISH assay was developed using probes that targeted the broad spectrum of HPV genotypes most commonly associated with CIN. In an exploratory study, tissue sections (n=118) were stained with H&E alone and H&E with HPV ISH and evaluated by 6 general surgical pathologists. Results were compared with diagnoses established by expert pathologists on H&E alone. The change in specificity (diagnosis of no-CIN) and sensitivity (diagnosis of CIN) using H&E plus HPV versus H&E alone was determined. The HPV ISH assay detected 21 HPV genotypes and demonstrated no cross-reactivity to Epstein-Barr virus, cytomegalovirus, herpes simplex virus (HSV)-1, HSV-2, or human placental DNA. The assay detected HPV in a range of 1 to 600 copies on CaSki, HeLa, and SiHa xenografts. Use of this assay with H&E staining improved the average diagnostic specificity of the surgical pathologists from 68.5% to 89.9% (P<0.001), with fewer false-positive CIN 1 results (122 vs. 39). The diagnostic sensitivity was similar for assessments made with H&E alone and those made with HPV plus H&E (93.1% vs. 93.6%). In conclusion, a new automated broad-spectrum HPV ISH assay combined with H&E-stained slides contributed to better ascertainment of CIN than H&E staining alone.
Wenjun Zhang; Monesh Kapadia; Michael Sugarman; Heather Free; Catherine Upchurch; Richard Gniewek; Katie White; Melanie Miller; Frank Vladich; Alex Ferenczy; Thomas C Wright; Mark H Stoler; Lidija Pestic-Dragovich
Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2012-9-26
Journal Detail:
Title:  International journal of gynecological pathology : official journal of the International Society of Gynecological Pathologists     Volume:  -     ISSN:  1538-7151     ISO Abbreviation:  Int. J. Gynecol. Pathol.     Publication Date:  2012 Sep 
Date Detail:
Created Date:  2012-9-28     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8214845     Medline TA:  Int J Gynecol Pathol     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
*Ventana Medical Systems Inc. (W.Z., M.K., M.S., H.F., C.U., R.G., K.W., M.M., F.V.), Tucson, Arizona †Department of Pathology and Obstetrics and Gynecology (A.F.), McGill University ‡Jewish General Hospital (A.F.), Montreal, Quebec, Canada §Department of Pathology and Cell Biology (T.C.W.), Columbia University, New York ∥Department of Pathology (M.H.S.), University of Virginia, Charlottesville, Virginia ¶Ventana Translational Diagnostics (L.P-D.), Penzberg, Germany.
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