Validation of AutoPap primary screening system sensitivity and high-risk performance.
OBJECTIVE
To confirm or deny the reported sensitivity of the AutoPap Primary Screening System (AutoPap) (TriPath Imaging Inc., Burlington, North Carolina, U.S.A) in a moderate-sized laboratory and to determine performance characteristics for the "clinically high risk" (CHR) patient population.


METHODS
Archives were searched for low and high grade squamous intraepithelial lesion (LSIL, HSIL), adenocarcinoma in situ (AIS) and cancer (Ca) with follow-up biopsies demonstrating a lesion of at least the reported Pap smear's severity. Smears fulfilling these criteria and a matched normal, control slide from the same day of preparation were subjected to evaluation on the AutoPap. Two hundred eighty-three smears from 254 patients were enrolled in the study, including 80 LSIL, 178 HSIL, 5 AIS and 20 Ca. Specific criteria established CHR status. Fisher's exact test was applied to determine AutoPap performance differences for non-CHR and CHR populations.


RESULTS
AutoPap successfully classified as "Review" all cases as follows: 91.2% LSIL (73/80), 96.6% HSIL (172/178), 100% AIS (5/5), and 100% Ca (20/20). Fisher's exact P values, pLSIL = 1.00 and pHSIL+ = .411, confirmed statistically equivalent performance.


CONCLUSIONS
The results confirmed the sensitivity data reported in the Food and Drug Administration-approved labeling of the AutoPap and indicated no statistically significant differences in performance characteristics in a CHR population when compared to patients without CHR status for all grades of abnormality examined.
Tench
William D
WD
Laboratory Services, Palomar Medical Center, 555 East Valley Parkway, Escondido, California 92025, USA.
D000230:Adenocarcinoma / Q000175:diagnosis / Q000473:pathology*; D002278:Carcinoma in Situ / Q000175:diagnosis / Q000473:pathology*; D003936:Diagnosis, Computer-Assisted; D005069:Evaluation Studies as Topic; D005260:Female; D006801:Humans; D011237:Predictive Value of Tests; D011379:Prognosis; D012189:Retrospective Studies; D012680:Sensitivity and Specificity; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis / Q000473:pathology*; D014626:Vaginal Smears / Q000295:instrumentation*; D002578:Uterine Cervical Dysplasia / Q000175:diagnosis / Q000473:pathology*