title: DNA ploidy compared with human papilloma virus testing (Hybrid Capture II) and conventional cervical cytology as a primary screening test for cervical high-grade lesions and cancer in 1555 patients with biopsy confirmation.
abstract: BACKGROUND
  Because 80% of cervical cancers arise in low-resource settings, many inexpensive strategies are being tested. In that spirit, the authors are testing large-scale genomic or DNA ploidy measurements as an inexpensive and semiautomated strategy.
  
  
  METHODS
  Patients entered either a screening or diagnostic study of several optical technologies: quantitative cytology, quantitative histopathology, and fluorescence and reflectance spectroscopy using a point probe, a multispectral digital colposcope, or a combination of the two. We calculated sensitivities, specificities, positive and negative predictive values, and their confidence interval testing conventional cytology, Hybrid Capture (HC) II testing, and DNA ploidy measured on the Feulgen-stained quantitative Pap smear.
  
  
  RESULTS
  The current investigation reports on 1555 patients for whom colposcopically directed biopsies were read 3 times by study pathologists. The final histopathologic diagnosis was high grade (cervical intraepithelial neoplasia [CIN] 2, CIN 3, carcinoma in situ [CIS], and cancer) in 16% of patients. Using high-grade squamous intraepithelial lesions (SILs) histopathology as the threshold and gold standard, the sensitivity and specificity, respectively, were: 0.47 and 0.96 for conventional cytology, 0.91 and 0.80 for HC II, and 0.59 and 0.93 for DNA ploidy. The positive and negative predictive values (PPV, NPV) for conventional cytology were 0.70 and 0.90, 0.46 and 0.98 for HC II, and 0.63 and 0.92 for DNA ploidy.
  
  
  CONCLUSIONS
  DNA ploidy shows comparable sensitivity, specificity, PPV, and NPV values to conventional cytology and HC II. Unlike conventional cytology, DNA ploidy is semiautomated and can be performed in less than 8 hours. Cost effectiveness studies are under way, but in the authors' laboratory DNA ploidy is inexpensive.
authors.affiliation: Department of Cancer Imaging, British Columbia Cancer Research Centre, Vancouver, British Columbia.
authors.forename: Martial
authors.initials: M
authors.lastname: Guillaud
authors.forename: John L
authors.initials: JL
authors.lastname: Benedet
authors.forename: Scott B
authors.initials: SB
authors.lastname: Cantor
authors.forename: Gregg
authors.initials: G
authors.lastname: Staerkel
authors.forename: Michele
authors.initials: M
authors.lastname: Follen
authors.forename: Calum
authors.initials: C
authors.lastname: MacAulay
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001706:Biopsy; D003127:Colposcopy; D020732:Cytogenetic Analysis; D004273:DNA, Neoplasm / Q000032:analysis*; D005260:Female; D005820:Genetic Testing / Q000191:economics / Q000379:methods*; D023281:Genomics; D006801:Humans; D008403:Mass Screening / Q000191:economics / Q000379:methods*; D008875:Middle Aged; D027383:Papillomaviridae / Q000302:isolation & purification; D011003:Ploidies; D012680:Sensitivity and Specificity; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis* / Q000473:pathology / Q000821:virology
chemical_list: D004273:DNA, Neoplasm