title: Primary cervical cancer screening and triage using an mRNA human papillomavirus assay and visual inspection.
abstract: OBJECTIVE
  Mexican Cervical Cancer Screening Study II (MECCS II) seeks to develop a highly sensitive and highly specific screening program able to be adapted to all socioeconomic levels in Mexico. The objectives of MECCS II are (1) to compare the sensitivity and specificity for cervical intraepithelial neoplasia (CIN) 3 or cancer of self-collected vaginal specimens tested for high-risk types of the human papillomavirus (HR-HPV) by APTIMA with those tested for HR-HPV by Hybrid Capture 2 (HC2); and (2) determine the efficacy of cryotherapy in the treatment of HR-HPV-positive and acetic acid-aided visual inspection (VIA)-positive and -negative women after VIA triage.
  
  
  METHODS
  The study was conducted in rural Mexico. Women aged 30 to 50 years, nonpregnant, with no history of hysterectomy or pelvic irradiation and varied histories of screening, participated. A direct endocervical sample was tested for cytology, HC2, and APTIMA assay (AHPV). Subjects positive on any test were recalled for triage VIA, biopsies, and immediate cryotherapy. Tests were compared using McNemar test.
  
  
  RESULTS
  Two thousand forty-nine patients have complete results. Mean age of the patients was 39.2 years; 7.7% presented with ≥atypical squamous cells of uncertain significance (ASCUS), 1.8% ≥low-grade squamous intraepithelial neoplasia, and 0.5% ≥high-grade squamous intraepithelial neoplasia. Two percent of patients had ≥CIN2, and 0.78% had ≥CIN3 (including 2 with invasive disease). The sensitivity of ThinPrep (>ASCUS), HC2, and AHPV for >CIN3 for direct endocervical collection was 87.5%, 100%, and 100%, respectively. The specificity of ThinPrep (>ASCUS), HC2, and AHPV for >CIN3 was 94.1%, 92.2%, and 93.5%, respectively. Specificities of HC2 and AHPV differed significantly. The overall percentage of agreement among HPV assays (HC2 vs APTIMA) is 97%. Four hundred sixty-nine women returned for VIA. Two hundred ninety-one women were treated with cryotherapy.
  
  
  CONCLUSIONS
  The specificity of the APTIMA assay along with high sensitivity is an advantage for primary screening. Follow-up evaluation will be important to determine the true impact of potential undertreatment in the screening algorithm. Self-sampling applications are explored.
authors: New Hanover Regional Medical Center, Wilmington, NC 28402, USA. lucybethnieves@hotmail.com
authors: Lucybeth
authors: L
authors: Nieves
authors: Christine L
authors: CL
authors: Enerson
authors: Suzanne
authors: S
authors: Belinson
authors: Jennifer
authors: J
authors: Brainard
authors: Andres
authors: A
authors: Chiesa-Vottero
authors: Norma
authors: N
authors: Nagore
authors: Christine
authors: C
authors: Booth
authors: Areli Gutierrez
authors: AG
authors: Pérez
authors: Mauricio N
authors: MN
authors: Chávez-Avilés
authors: Jerome
authors: J
authors: Belinson
mesh_terms: D019342:Acetic Acid; D000328:Adult; D002294:Carcinoma, Squamous Cell / Q000175:diagnosis* / Q000453:epidemiology / Q000821:virology; D002584:Cervix Uteri / Q000473:pathology; D003581:Cytodiagnosis; D004279:DNA, Viral / Q000235:genetics; D055088:Early Detection of Cancer; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008403:Mass Screening; D008800:Mexico / Q000453:epidemiology; D008875:Middle Aged; D060787:Neoplasm Grading; D009367:Neoplasm Staging; D027383:Papillomaviridae / Q000235:genetics; D030361:Papillomavirus Infections / Q000175:diagnosis* / Q000453:epidemiology / Q000821:virology; D015995:Prevalence; D011379:Prognosis; D012333:RNA, Messenger / Q000235:genetics; D060888:Real-Time Polymerase Chain Reaction; D020133:Reverse Transcriptase Polymerase Chain Reaction; D012680:Sensitivity and Specificity; D013048:Specimen Handling; D002578:Uterine Cervical Dysplasia / Q000175:diagnosis* / Q000453:epidemiology / Q000821:virology; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis* / Q000453:epidemiology / Q000821:virology; D014626:Vaginal Smears
chemical_list: D004279:DNA, Viral; D012333:RNA, Messenger; D019342:Acetic Acid