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.
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.
Wulan
Na
N
Department of Obstetrics and Gynecology, Peking University, Shenzhen Hospital, 1120 Lianhua Rd, Futian Shenzhen, China. wlnaa@hotmail.com
Rasool
Nabila
N
Belinson
Suzanne E
SE
Wang
Chun
C
Rong
Xuan
X
Zhang
Wei
W
Zhu
Yasha
Y
Yang
Bin
B
Tresser
Nancy J
NJ
Mohr
Mary
M
Wu
Ruifang
R
Belinson
Jerome L
JL
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
D007202:Indicators and Reagents; D019342:Acetic Acid