A feasibility study of the use of the AutoPap screening system as a primary screening and location-guided rescreening device.
BACKGROUND
The AutoPap 300 QC system (Tripath Imaging, Inc., Burlington, NC) is an automated device that was designed to screen conventionally prepared cervical smears and, more recently, thin-layer slide preparations. The system has been tested in large clinical trials.


METHODS
A total of 14,145 cervical smears obtained from participants in the Florence screening program were eligible for the study. Smears were processed first with the AutoPap system and were classified into three different categories: 1) no further review (NFR), 2) review, and 3) process review (PR). Conventional manual reading was performed by 10 experienced cytopathologists.


RESULTS
After AutoPap processing, 2398 smears were classified as NFR (16.9%), and 1818 smears were classified as PR (12.8%). Overall, there were 188 inadequate smears (1.3%) at conventional review and 125 inadequate smears (0.88%) at AutoPap review. Six-month repeat smears were prompted by 330 conventional reviews (2.3%) and by 222 AutoPap reviews (1.56%). Similarly, referral to colposcopy was prompted by 179 conventional reviews (1.2%) and by 147 AutoPap reviews (1.0%). Overall, 32 patients were diagnosed with high-grade cervical intraepithelial neoplasia as a result of assessment. Conventional reading detected 31 patients (28 patients were referred for colposcopy, and 3 patients were referred for repeat cytology), and the AutoPap system detected 30 patients (27 patients were referred for colposcopy, and 3 patients were referred for repeat cytology).


CONCLUSIONS
The current experience suggested that conventional reading and AutoPap reading of cervical smears had essentially the same sensitivity, with slightly greater specificity for the AutoPap system. Thus, comparisons of the AutoPap system and conventional reading should focus mainly on cost analysis.
Confortini
Massimo
M
Cytology Unit, Centro Per Lo Studio E La Prevenzione Oncologica, Florence, Italy. m.conforti@cspo.it
Bonardi
Lucia
L
Bulgaresi
Paolo
P
Cariaggi
Maria Paola
MP
Cecchini
Silvia
S
Ciatto
Stefano
S
Cipparrone
Ida
I
Galanti
Laura
L
Maddau
Cristina
C
Matucci
Marzia
M
Rubeca
Tiziana
T
Troni
Grazia Maria
GM
Turco
Patricia
P
Zappa
Marco
M
Carozzi
Francesca
F
D001331:Automation; D003365:Costs and Cost Analysis; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008403:Mass Screening / Q000379:methods*; D012680:Sensitivity and Specificity; D002583:Uterine Cervical Neoplasms / Q000473:pathology; D014626:Vaginal Smears / Q000191:economics / Q000295:instrumentation / Q000379:methods*; D002578:Uterine Cervical Dysplasia / Q000473:pathology