Multicenter comparison of manual and automated screening of AutoCyte gynecologic preparations

OBJECTIVE: To compare AutoCyte SCREEN-assisted evaluation of AutoCyte PREP liquid-based preparations with manual microscopic screening of the same pre parations in a masked, multisite trial. STUDY DESIGN: AutoCyte PREPs were made using the CytoRich automated, liquid -based method from the residual cellular material on the collection device after a conventional cervical smear had been made. The study involved 1,676 samples collected sequentially from high-risk patients at two medical cent ers. The AutoCyte PREPs were then screened manually by cytotechnologists at one of two laboratory sites. All abnormal slides were reviewed by the site pathologists for final diagnosis. The PREPs were then remasked and screene d using the AutoCyte SCREEN automated, interactive screening system, design ed to select potentially abnormal slides for manual review while allowing t he direct sign-out of negative slides. The AutoCyte SCREEN-assisted practic e result was determined by combining the interactive SCREEN result with man ual evaluation for those cases selected by SCREEN for manual review. All sl ides deemed abnormal were manually reviewed by an independent reference pat hologist. The original manual review results were then compared to the Auto Cyte SCREEN-assisted practice results stratified by the Bethesda categories of abnormal diagnoses as determined by the reference pathologist. RESULTS: Of the 1,676 cases, 494 were determined to be abnormal (ASCUS +) b y one or both of the study methods and also by the independent reference pa thologist. Of these 494 abnormal cases, 312 had a reference diagnosis of LS IL +, and 139 had a reference diagnosis of HSIL or cancer. The remainder of these cases were ASCUS or AGUS. Sensitivities and false negative proportio ns were stratified by the reference pathologist based on Bethesda categorie s as "truth" and comparrd. For LSIL + cases, manual screening alone had a s ensitivity of 89% as compared to 98% for the AutoCyte SCREEN-assisted pract ice. Manual screening demonstrated 90% sensitivity to HSIL or greater abnor mality as compared to 99% sensitivity by the AutoCyte SCREEN-assisted pract ice. CONCLUSION: There was a concurrent significant reduction in the false negat ive function using the AutoCyte SCREEN as part of screening practice. Speci ficity for both screening practices tons equivalent.