title: A comprehensive evaluation of the accuracy of cervical pre-cancer detection methods in a high-risk area in East Congo.
abstract: BACKGROUND
  Given the high burden of cervical cancer in low-income settings, there is a need for a convenient and affordable method for detecting and treating pre-cancerous lesions.
  
  
  METHODS
  Samples for comparing the accuracy of cytology, virology and histology were collected. Identification of HPV E6/E7 mRNA was performed using PreTect HPV-Proofer. HPV DNA detection was performed by GP5+/6+ PCR, followed by reverse line blot (RLB) for typing.
  
  
  RESULTS
  A total of 343 women, aged 25-60 years, attending gynaecological polyclinics in DR Congo were included for sample enrolment. The test positivity rate was conventional and liquid-based cytology (LBC) at cutoff ASCUS+ of 6.9 and 6.6%, respectively; PreTect HPV-Proofer of 7.3%; and consensus DNA PCR for 14 HR types of 18.5%. Sixteen cases of CIN2+ lesions were identified. Of these, conventional cytology identified 66.7% with a specificity of 96.2%, LBC identified 73.3% with a specificity of 96.9%, all at cutoff ASCUS+. HR-HPV DNA detected all CIN2+ cases with a specificity of 85.9%, whereas PreTect HPV-Proofer gave a sensitivity of 81.3% and a specificity of 96.6%.
  
  
  CONCLUSIONS
  Both HPV detection assays showed a higher sensitivity for CIN2+ than did cytological methods. Detecting E6/E7 mRNA from only a subset of HR HPVs, as is the case with PreTect HPV-Proofer, resulted in a similar specificity to cytology and a significantly higher specificity than consensus HR HPV DNA (P<0.0001).
authors.affiliation: NorChip AS, Industriveien 8, Klokkarstua 3490, Norway. Siri.hovland@norchip.com
authors.forename: S
authors.initials: S
authors.lastname: Hovland
authors.forename: M
authors.initials: M
authors.lastname: Arbyn
authors.forename: A K
authors.initials: AK
authors.lastname: Lie
authors.forename: W
authors.initials: W
authors.lastname: Ryd
authors.forename: B
authors.initials: B
authors.lastname: Borge
authors.forename: E J
authors.initials: EJ
authors.lastname: Berle
authors.forename: H
authors.initials: H
authors.lastname: Skomedal
authors.forename: T M
authors.initials: TM
authors.lastname: Kadima
authors.forename: L
authors.initials: L
authors.lastname: Kyembwa
authors.forename: E M
authors.initials: EM
authors.lastname: Billay
authors.forename: D
authors.initials: D
authors.lastname: Mukwege
authors.forename: R B
authors.initials: RB
authors.lastname: Chirimwami
authors.forename: T M
authors.initials: TM
authors.lastname: Mvula
authors.forename: P J
authors.initials: PJ
authors.lastname: Snijders
authors.forename: C J L M
authors.initials: CJ
authors.lastname: Meijer
authors.forename: F
authors.initials: F
authors.lastname: Karlsen
mesh_terms: D000328:Adult; D000465:Algorithms; D052685:Alphapapillomavirus / Q000235:genetics / Q000302:isolation & purification; D003223:Congo / Q000453:epidemiology; D004279:DNA, Viral / Q000032:analysis / Q000235:genetics; D055088:Early Detection of Cancer / Q000379:methods*; D005260:Female; D006801:Humans; D008875:Middle Aged; D011230:Precancerous Conditions / Q000175:diagnosis* / Q000453:epidemiology / Q000821:virology; D011237:Predictive Value of Tests; D012307:Risk Factors; D012680:Sensitivity and Specificity; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis* / Q000453:epidemiology / Q000209:etiology; D002578:Uterine Cervical Dysplasia / Q000175:diagnosis* / Q000453:epidemiology / Q000209:etiology
chemical_list: D004279:DNA, Viral