title: Evaluation of quantity and staining pattern of human papillomavirus (HPV)-infected epithelial cells in thin-layer cervical specimens using optimized HPV-CARD assay.
abstract: BACKGROUND
  Testing for human papillomavirus (HPV) is used in the triage of women with a cervical cytology of atypical squamous cells of undetermined significance (ASCUS). A fluorescent in situ hybridization assay was developed for the detection of HPV using the catalyzed receptor deposition technique (HPV-CARD). In this study, the utility of this assay was tested for the detection of HPV in liquid-based cervical cytology specimens.
  
  
  METHODS
  A total of 195 liquid-based cytology specimens were analyzed using the HPV-CARD assay. The results from the assay were compared with HPV polymerase chain reaction (PCR) and typing results. The number of HPV-infected cells and the staining pattern was correlated with the cytology classification.
  
  
  RESULTS
  A 91% concordance between HPV-CARD and PCR was observed for the detection of high-risk HPV viruses. A 78% concordance was observed for specimens that were negative for HPV. In ASCUS, low-grade squamous intraepithelial lesion (LSIL), and high-grade squamous intraepithelial lesion (HSIL) categories, the average number of HPV-positive cells per slide was 19 cells, 127 cells, and 450 cells, respectively. The number of cells with a punctate staining, suggestive of HPV integration, was 21% in ASCUS, 34% in LSIL, and 46% in HSIL specimens.
  
  
  CONCLUSIONS
  The results of the current study indicate positive correlations between the severity of the disease and the increased overall quantity of HPV-positive epithelial cells in cervical cytology specimens and accumulation of cells with punctate staining suggestive of integrated HPV. In summary, the developed HPV-CARD assay was found to provide novel information regarding the proportion and staining pattern of HPV-infected epithelial cells in different cytologic categories of cervical specimens.
authors.affiliation: Research and Development, Abbott Molecular, Inc., Des Plaines, Illinois 60018, USA.
authors.forename: Alicia
authors.initials: A
authors.lastname: Algeciras-Schimnich
authors.forename: Frank
authors.initials: F
authors.lastname: Policht
authors.forename: Svetlana
authors.initials: S
authors.lastname: Sitailo
authors.forename: Minghao
authors.initials: M
authors.lastname: Song
authors.forename: Larry
authors.initials: L
authors.lastname: Morrison
authors.forename: Irina
authors.initials: I
authors.lastname: Sokolova
mesh_terms: D002294:Carcinoma, Squamous Cell / Q000821:virology; D003127:Colposcopy; D015344:DNA Probes, HPV; D004279:DNA, Viral; D004847:Epithelial Cells / Q000821:virology*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D017404:In Situ Hybridization, Fluorescence; D027383:Papillomaviridae / Q000302:isolation & purification*; D030361:Papillomavirus Infections / Q000821:virology*; D012680:Sensitivity and Specificity; D002583:Uterine Cervical Neoplasms / Q000821:virology*; D014626:Vaginal Smears; D002578:Uterine Cervical Dysplasia / Q000821:virology
chemical_list: D015344:DNA Probes, HPV; D004279:DNA, Viral