title: Cytology and human papillomavirus testing 6 to 12 months after ASCUS or LSIL cytology in organized screening to predict high-grade cervical neoplasia between screening rounds.
abstract: We carried out a prospective study comparing the performance of human papillomavirus (HPV) E6/E7 mRNA (PreTect HPV-Proofer; NorChip, Klokkarstua, Norway) and DNA (Amplicor HPV test; Roche Diagnostics, Basel, Switzerland) triage testing of women 6 to 12 months after atypical-squamous-cells-of-undetermined-significance (ASCUS) or low-grade-squamous-intraepithelial-lesion (LSIL) cytology in organized screening to predict high-grade cervical intraepithelial neoplasia of grade 2 or worse (CIN2+) between screening rounds. Between January 2005 and April 2008, 692 study women with screening-detected ASCUS/LSIL cytology 6 to 12 months earlier returned for HPV mRNA and DNA testing and repeat cytology. The median follow-up time was 3 years, using existing health care facilities. Follow-up test results were available for 625 women. Of the 145 CIN2+ cases detected during the study period, 95 (65.5%) were HPV mRNA positive 6 to 12 months after screening-detected ASCUS/LSIL, 44 (30.4%) were HPV mRNA negative, and 6 (4.1%) were invalid. The corresponding HPV DNA results were 139 (95.9%), 5 (3.4%), and 1 (0.7%), respectively. The cumulative incidences of CIN2+ 3 years after a negative HPV mRNA and DNA test were 10.3% (95% confidence interval [CI], 7.2 to 13.3%) and 1.8% (95% CI, 0.0 to 3.6%), respectively. The cumulative incidences of CIN2+ 3 years after positive HPV mRNA and DNA tests were 52.8% (95% CI, 40.1 to 60.1%) and 41.3% (95% CI, 35.5 to 46.6%), respectively. In conclusion, both positive HPV mRNA and DNA test results have a high enough long-term prediction of CIN2+ risk to consider referral to colposcopy as good practice when performed in delayed triage of women with ASCUS/LSIL cytology. In addition, the low CIN2+ risk among women with a negative Amplicor HPV test in our study confirms its safe use in a clinical setting.
authors.affiliation: Department of Obstetrics and Gynaecology, Akershus University Hospital, Lørenskog, Norway. ameli.trope@mac.com
authors.forename: Ameli
authors.initials: A
authors.lastname: Tropé
authors.forename: Katrine D
authors.initials: KD
authors.lastname: Sjøborg
authors.forename: Mari
authors.initials: M
authors.lastname: Nygård
authors.forename: Kjetil
authors.initials: K
authors.lastname: Røysland
authors.forename: Suzanne
authors.initials: S
authors.lastname: Campbell
authors.forename: G Cecilie
authors.initials: GC
authors.lastname: Alfsen
authors.forename: Christine M
authors.initials: CM
authors.lastname: Jonassen
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003584:Cytological Techniques / Q000379:methods*; D004279:DNA, Viral / Q000235:genetics / Q000302:isolation & purification; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D008403:Mass Screening / Q000379:methods*; D008875:Middle Aged; D009664:Norway; D027383:Papillomaviridae / Q000235:genetics / Q000302:isolation & purification; D030361:Papillomavirus Infections / Q000150:complications / Q000175:diagnosis* / Q000473:pathology / Q000821:virology; D011379:Prognosis; D011446:Prospective Studies; D012367:RNA, Viral / Q000235:genetics / Q000302:isolation & purification; D013557:Switzerland; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis* / Q000473:pathology / Q000821:virology; D014773:Virology / Q000379:methods*; D055815:Young Adult
chemical_list: D004279:DNA, Viral; D012367:RNA, Viral