title: Screening for cervical cancer in high-risk populations: DNA pap test or Hybrid Capture II test alone?
abstract: This study was designed to evaluate whether Hybrid Capture II (HC2) test alone refer women to colposcopy as appropriately as DNA Papanicolaou (Pap) test, in the context of a high-risk group of women using the recently validated DNACitoliq LBC system. Women with suspected cervical disease were included in this cross-sectional study at a tertiary center in São Paulo, Brazil, for further workup. All women had cervical material collected for LBC and HC2 for high-risk human papillomavirus (hrHPV)-DNA test. Irrespective of cytology and HC2 results, colposcopy, and cervical biopsy when applicable, was systematically performed. All tests were performed blindly. Sensitivity, specificity, positive and negative predictive values, and overall accuracy of both methods were computed in relation to histology. A total of 1,080 women were included: 36.4% (393/1080) had ACUS+, 10.2% (110/1080) were high-grade squamous intraepithelial lesions (HSIL) or cancer. Mean age was 33.5 years. All women underwent colposcopy, and cervical biopsies were performed in 38.4% (415/1080): 33% (137/415) of the biopsies were negative, 14.4% (155/415) were low-grade squamous intraepithelial lesions (LSIL), 10.7% (116/415) were HSIL, and 0.6% (7/415) were cancer. HC2 sensitivity to diagnose biopsy-proven HSIL was 100%. Because all HSIL cases had a positive HC2 test, sensitivity could not be improved by adding LBC. Specificity and positive and negative predictive values of DNA Pap were not significantly different from HC2 test alone when considering LSIL+ histology as "gold standard" and HSIL+ histology. As a screening strategy for women with high-risk for cervical cancer, DNA Pap test does not seem to add substantially to HC2 alone in terms of appropriately referring to colposcopy.
authors.affiliation: Division of Pathology, Adolfo Lutz Institute, São Paulo, Brasil.
authors.forename: Sônia Maria
authors.initials: SM
authors.lastname: Miranda Pereira
authors.forename: Adauto
authors.initials: A
authors.lastname: Castelo
authors.forename: Sérgio
authors.initials: S
authors.lastname: Makabe
authors.forename: Maria Lúcia
authors.initials: ML
authors.lastname: Utagawa
authors.forename: Celso
authors.initials: C
authors.lastname: Di Loreto
authors.forename: Marina Yoshiê
authors.initials: MY
authors.lastname: Sakamoto Maeda
authors.forename: José A
authors.initials: JA
authors.lastname: Marques
authors.forename: Carmen L F
authors.initials: CL
authors.lastname: Santoro
authors.forename: Adhemar Longatto
authors.initials: AL
authors.lastname: Filho
authors.forename: Gerson Botacini
authors.initials: GB
authors.lastname: Das Dores
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001706:Biopsy; D003127:Colposcopy; D004279:DNA, Viral / Q000032:analysis; D005260:Female; D006801:Humans; D008403:Mass Screening / Q000379:methods*; D008875:Middle Aged; D065006:Papanicolaou Test; D027383:Papillomaviridae / Q000235:genetics / Q000302:isolation & purification*; D030361:Papillomavirus Infections / Q000175:diagnosis; D011237:Predictive Value of Tests; D016037:Single-Blind Method; D014412:Tumor Virus Infections / Q000175:diagnosis* / Q000821:virology; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis* / Q000517:prevention & control / Q000821:virology; D014626:Vaginal Smears / Q000379:methods*; D002578:Uterine Cervical Dysplasia / Q000175:diagnosis / Q000821:virology
chemical_list: D004279:DNA, Viral