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Acta Cytol. 2002 Mar-Apr;46(2):296-302.

Validation of AutoPap primary screening system sensitivity and high-risk performance.

Author information

1
Laboratory Services, Palomar Medical Center, 555 East Valley Parkway, Escondido, California 92025, USA.

Erratum in

  • Acta Cytol 2002 May-Jun;46(3):611.

Abstract

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.

STUDY DESIGN:

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.

CONCLUSION:

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.

PMID:
11917576
DOI:
10.1159/000326725
[Indexed for MEDLINE]

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