title: Study of the diagnostic efficacy of real-time optical coherence tomography as an adjunct to unaided visual inspection with acetic acid for the diagnosis of preinvasive and invasive neoplasia of the uterine cervix.
abstract: OBJECTIVE
  To determine the sensitivity and specificity of optical coherence tomography (OCT) as an adjunct to unaided visual inspection using acetic acid (VIA) in the detection of cervical intraepithelial neoplasia 2 (CIN 2) in a real-time clinical evaluation.
  
  
  BACKGROUND
  This clinical study was a prospective cross-sectional comparative trial that screened 1000 patients (aged 30-50 years) in a low-resource setting. Women with abnormal cervical cytology or positive human papillomavirus (HPV) tests were referred for further evaluation including VIA, OCT imaging, colposcopy, and cervical biopsies.
  
  
  METHODS
  The VIA diagnoses were coded by quadrant. The OCT was then performed in all VIA-positive areas and at the squamocolumnar junction in all 4 quadrants. All patients were colposcoped; assessed by quadrant with biopsies at 2, 4, 8, and 10 o'clock; all abnormal areas were biopsied; and endocervical curettage was performed. Data were analyzed using generalized estimating equations and logistic regression.
  
  
  RESULTS
  Of the 1000 patients, 175 (17.5%) were HPV positive, 93 (9.3%) had abnormal cervical cytology greater than or equal to atypical squamous cells of undetermined significance, and 211 (21.1%) were either HPV positive or had abnormal cytology. The VIA, OCT, colposcopy, and biopsies were completed on 183 (86.7%) of 211 women. For VIA alone, the sensitivity and specificity in detecting lesions greater than or equal to CIN 2 was 43% and 96%. With the addition of OCT, the sensitivity increases to 62% with a specificity of 80%.
  
  
  CONCLUSIONS
  With the addition of OCT, the sensitivity of VIA increased in all analyses for the detection of greater than or equal to CIN II, with a loss in specificity. We hope that the potential of this technology will be realized when a computer algorithm is generated to aid in image interpretation.
authors.affiliation: Department of Obstetrics and Gynecology, Peking University, Shenzhen Hospital, 1120 Lianhua Rd, Futian Shenzhen, China. wlnaa@hotmail.com
authors.forename: Na
authors.initials: N
authors.lastname: Wulan
authors.forename: Nabila
authors.initials: N
authors.lastname: Rasool
authors.forename: Suzanne E
authors.initials: SE
authors.lastname: Belinson
authors.forename: Chun
authors.initials: C
authors.lastname: Wang
authors.forename: Xuan
authors.initials: X
authors.lastname: Rong
authors.forename: Wei
authors.initials: W
authors.lastname: Zhang
authors.forename: Yasha
authors.initials: Y
authors.lastname: Zhu
authors.forename: Bin
authors.initials: B
authors.lastname: Yang
authors.forename: Nancy J
authors.initials: NJ
authors.lastname: Tresser
authors.forename: Mary
authors.initials: M
authors.lastname: Mohr
authors.forename: Ruifang
authors.initials: R
authors.lastname: Wu
authors.forename: Jerome L
authors.initials: JL
authors.lastname: Belinson
mesh_terms: D019342:Acetic Acid; D000293:Adolescent; D000328:Adult; D002294:Carcinoma, Squamous Cell / Q000175:diagnosis* / Q000821:virology; D003127:Colposcopy; D003430:Cross-Sectional Studies; D005260:Female; D052162:Human papillomavirus 16 / Q000302:isolation & purification; D006801:Humans; D007202:Indicators and Reagents; D008875:Middle Aged; D009361:Neoplasm Invasiveness; D009367:Neoplasm Staging; D030361:Papillomavirus Infections / Q000175:diagnosis / Q000821:virology; D011379:Prognosis; D011446:Prospective Studies; D012680:Sensitivity and Specificity; D041623:Tomography, Optical Coherence; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis* / Q000821:virology; D055815:Young Adult; D002578:Uterine Cervical Dysplasia / Q000175:diagnosis* / Q000821:virology
chemical_list: D007202:Indicators and Reagents; D019342:Acetic Acid