Implementation and evaluation of a new automated interactive image analysis system.
OBJECTIVE
To compare automated interactive screening using the ThinPrep Imaging System with independent manual primary screening of 12,000 routine ThinPrep slides.


METHODS
With the first 6,000 cases, the Review Scopes (RS) screening results from the 22 fields of view (FOV) only were compared to independent manual primary screening. In the next 6,000 cases, any abnormality detected in the 22 FOV resulted in full manual screening on the cytotechnologist's own microscope. Sensitivity and specificity together with their 95% CIs were calculatedfor each method.


RESULTS
In the first set of 6, 000 cases, diagnostic sensitivity and specificity of the imager were 85.19% and 96.67%, respectively. The diagnostic sensitivity and specificity of manual primary screening were 89.38% and 98.42%. This highersensitivity and specificity of manual primary screening were found to be statistically significant. The second set of 6,000 cases demonstrated no significant statistical difference in sensitivity or specificity between the sets of data.


CONCLUSIONS
The results from our study show that the sensitivity and specificity of the imager technology are equivalent to those of manual primary screening. The system is ideally suited to the rapid screening of negative cases, allowing increased laboratory productivity and greater throughput of cases on a daily basis.
Bolger
Noel
N
Department of Cytopathology, Coombe Women's Hospital, Dublin, Ireland. nbolger@coombe.ie
Heffron
Cynthia
C
Regan
Irene
I
Sweeney
Mary
M
Kinsella
Sinead
S
McKeown
Mary
M
Creighton
Grace
G
Russell
Joan
J
O'Leary
John
J
D002277:Carcinoma / Q000175:diagnosis*; D002584:Cervix Uteri / Q000473:pathology*; D003951:Diagnostic Errors / Q000517:prevention & control; D005188:False Negative Reactions; D005260:Female; D006801:Humans; D019044:Image Cytometry / Q000379:methods* / Q000706:statistics & numerical data / Q000639:trends; D008403:Mass Screening / Q000379:methods / Q000706:statistics & numerical data / Q000639:trends; D015588:Observer Variation; D010363:Pattern Recognition, Automated / Q000379:methods* / Q000706:statistics & numerical data / Q000639:trends; D011237:Predictive Value of Tests; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis*; D014626:Vaginal Smears / Q000379:methods* / Q000706:statistics & numerical data / Q000639:trends