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Objective: To compare AutoCyte SCREEN-assisted evaluation of AutoCyte PREP liquid-based preparations with manual microscopic screening of the same preparations in a masked, multisite trial., Study Design: AutoCyte PREPs were made using the CytoRich automated, liquidbased 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 centers. 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 screened using the AutoCyte SCREEN automated, interactive screening system, designed to select potentially abnormal slides for manual review while allowing the direct sign-out of negative slides. The AutoCyte SCREEN-assisted practice result was determined by combining the interactive SCREEN result with manual evaluation for those cases selected by SCREEN for manual review. All slides deemed abnormal were manually reviewed by an independent reference pathologist. The original manual review results were then compared to the AutoCyte 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+) by one or both of the study methods and also by the independent reference pathologist. Of these 494 abnormal cases, 312 had a reference diagnosis of LSIL+, and 139 had a reference diagnosis of HSIL or cancer. The remainder of these cases were ASCUS or AGUS. Sensitivities and false negative proportions were stratified by the reference pathologist based on Bethesda categories as "truth" and compared. For LSIL+ cases, manual screening alone had a sensitivity of 89% as compared to 98% for the AutoCyte SCREEN-assisted practice. Manual screening demonstrated 90% sensitivity to HSIL or greater abnormality as compared to 99% sensitivity by the AutoCyte SCREEN-assisted practice., Conclusion: There was a concurrent significant reduction in the false negative fraction using the AutoCyte SCREEN as part of screening practice. Specificity for both screening practices was equivalent.

Objective: To ascertain the utility of residual liquid-preserved cervical cytology samples for DNA profiling studies., Study Design: Ninety-nine liquid-preserved cervical cytology samples from a high-risk population were received two months after the initial diagnosis at another laboratory. Each residual sample was processed to yield one Papanicolaou-stained and one Feulgen-thionin-stained slide. The former were examined manually without knowledge of the submitted findings and were also examined on the AutoCyte SCREEN interactive system. DNA profiling of > 185 cells per case was performed on an RPW image analyzer. Results were compared with submitted diagnoses., Results: The 99 cases included 59 normals, 9 ASCUS/AGCUS, 16 HSIL, 12 carcinomas and 3 unsatisfactory. Interlaboratory agreement between residual and initial samples was good (unweighted kappa = .609). Abnormals were characterized by 2C deviation indices > 2.0 and 5C exceeding rates > 4.37%. AutoCyte SCREEN system examination of residual slides of high grade abnormalities was 100% sensitive and 40% specific., Conclusion: Residual AutoCyte cervical cytology samples are stable and yield reproducible results for routine and ancillary studies of cervical cytologic abnormalities. The AutoCyte SCREEN system was 100% sensitive for high grade abnormalities in this enriched sample, even when operating on residual material.

During a study of eosinophil-predominant gallbladder disease, an image analysis (IA) technique was developed for quantification of eosinophils and lymphocytes in routine formalin-fixed tissue sections. Alternating sections were stained with hematoxylin and eosin for eosinophils and with monoclonal CD45 antibody visualized with diaminobenzidine by an avidin-biotin procedure for lymphocytes. A protocol was then developed using a commercially available image analyzer and two well-defined macro routines. The system was validated with cell block sections prepared from peripheral blood samples with known eosinophil and lymphocyte counts. The eosinophil counts obtained by this IA technique showed excellent correlation with the absolute counts from a peripheral blood analyzer (r2 = 0.987). The lymphocyte counts obtained by IA showed good correlation with the absolute counts (r2 = 0.820). This IA-based technique provides a sensitive, reproducible, and substantiated means of quantifying inflammatory cells in tissue sections. This rapid and easily learned technique adds quantification as a complementary dimension to the subjective assessment of tissue morphology.