Evaluation of the FocalPoint GS system performance in an Italian population-based screening of cervical abnormalities.
OBJECTIVE
To evaluate the FocalPoint Location-Guided Screening (FPGS) performance in computer-assisted primary screening of Papanicolaou-stained cervicovaginal smears.


METHODS
A total of 37,306 routine consecutive conventional Pap slides were prospectively processed on the FPGS. Each slid designated by the instrument as Review was reported according to results obtained using a GS Review Station. Subsequently, all slides under went conventional manual rapid screening and reported results were compared.


RESULTS
Of the slides initially submitted to the FPGS, 34,004 (91.15%) were qualified for scanning. Within these slides, the system classified 7,399 (21.8%) as needing No Further Review and ranked to Review the remaining 26,605 (78.2%). Of the 418 cellular abnormalities found, 409 were classified for Review by FPGS and 9 minor grade lesions were classified in the "No Further Review" population. Overall, 352 (86%) of atypical squamous cell (ASC)+ were ranked in high-score quintiles, including 96 (94%) of the 102 high-grade squamous intraepithelial lesion (HSIL) or worse. Location-guided software identified cellular abnormalities, in the automatically selected fields of view, in 378 (92%) of the ranked abnormal slides, showing a sensitivity > 95% on SILs.


CONCLUSIONS
Slide ranking and location-guided screening features are of value in detecting and triaging abnormal smears.
Passamonti
Basilio
B
Department of Clinical Pathology, Cytology Center, Perugia, Italy. bpassamonti@ausl2.umbria.it
Bulletti
Simonetta
S
Camilli
Maria
M
D'Amico
Maria Rosaria
MR
Di Dato
Eugenio
E
Gustinucci
Daniela
D
Martinelli
Nadia
N
Malaspina
Morena
M
Spita
Nicoletta
N
D000328:Adult; D003936:Diagnosis, Computer-Assisted; D005260:Female; D006801:Humans; D007558:Italy; D008403:Mass Screening / Q000379:methods*; D008875:Middle Aged; D065006:Papanicolaou Test; D011446:Prospective Studies; D002577:Uterine Cervical Diseases / Q000145:classification / Q000175:diagnosis* / Q000517:prevention & control*; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis / Q000517:prevention & control; D014626:Vaginal Smears / Q000379:methods*; D002578:Uterine Cervical Dysplasia / Q000175:diagnosis