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Objective: To compare agreement of pathologists and cytotechnologists and technologist productivity before and after implementation of the Cytyc ThinPrep Imager., Study Design: Using the Cytyc ThinPrep Imaging System, a retrospective analysis was conducted, from the first 6 months in 2004 and in 2005. Total cases in January through June were 79,791 in 2004 and 76,887 in 2005. Data on the number and type of changes from one impression to another were collected in a "confusion matrix". The chi2 test with 1 degree of freedom was used to calculate the significance of the difference between the groups., Results: Changes in diagnosis were most frequently seen in negative for intraepithelial lesion, atypical squamous cells of undetermined significance and low-grade squamous intraepithelial lesion. Interobserver agreement before the imager (weighted kappa) was 0.74 and after was 0.73., Conclusions: The number of high-grade lesions detected increased with the imager (p < 0.01). Technologist productivity increased by an average of 2.2 slides/hour.

To obtain an adequate cervical smear for making a correct cytologic diagnosis, smear taking, laboratory handling and interpretation must be optimal. Many people are involved, and only by a combined effort of all links can this target be seriously approached: the smear takers will have to be open minded about technical improvements and read the morphologic descriptions cautiously; in the laboratory, cytotechnicians and physicians will have to challenge themselves and each other. It is mandatory to discard specimens that do not meet general standards of adequacy. At present a host of new techniques are being implemented. It is not feasible for all laboratories to be engaged in testing these new methods, but we are all requested to follow the development the best we can and switch to new ways when justified. Our working conditions are very different; therefore, it is our professional responsibility and plight to respond at the right time. So far the conclusion is that the conventional Pap smear is the international standard of care for the diagnosis of cervical cancer precursers in cancer screening programs. Certainly, this may change within a very short time. Liquid-based techniques, and in particular HPV technologies, are just around the corner.

New technologies are trying to make significant changes in the way we perform the Pap smear test, a test that has undergone no significant modification since its inception. Efforts have focused on improving sampling with liquid-based methods, improving detection of abnormal cells with automated screening and improving the detection of human papillomavirus with assays practical for use in routine clinical material. This article reviews the performance of the new technologies to date, with an emphasis on those that are currently approved for cervical cytology testing. In the aggregate, these technologies can have a positive impact on cervical disease detection and intervention.

Cervical cancer continues to be a major cause of death in women worldwide. The major problem facing most women is the unavailability of screening Pap tests in poor and underdeveloped countries. While rates of cancer deaths have decreased 60-80% in developed countries since the Pap test became available, the accuracy of Paps was challenged recently. In order to instill public confidence and promote optimal patient care, measures to improve the quality of the entire screening process should be undertaken. Continuous quality improvement processes are more appropriate than traditional quality assurance monitors. Although no standards can be defined that are applicable to all laboratory settings and nations, this document provides current views on universal quality procedures and risk reduction. Procedure/policy manuals, workload assessment, hierarchic/peer review, discrepancy analysis, rescreening studies and cytohistologic correlation are examples of universally applicable quality tools. The variability in practices in different parts of the world is also discussed.

Objective: To compare the AutoCyte Prep system (Burlington, North Carolina) with conventional cervical cytology in a university medical center laboratory., Study Design: Split-sample conventional and AutoCyte Preps were examined for 2,156 cases. Same-patient conventional and Prep slides were submitted to separate cytotechnologists blindly. The results were compared on review by a cytopathologist. The Prep slides were subsequently scanned on the AutoCyte Screen automated interactive system, with manual review of the flagged cases. The results were compared with anatomic pathology follow-up when available., Results: Of the 158 squamous intraepithelial lesions (SILs) found by both methods, 78% were found by AutoCyte Prep, while 59% were found by conventional smear (P < .01). Among the discordant cases, thin-layer slides revealed 88% more LSIL lesions (P < .05), a comparable number of high grade SIL lesions and a single case of adenocarcinoma that was ambiguous on the conventional slide. The addition of AutoCyte assisted primary screening demonstrated a net benefit, recovering additional cases referenced as atypical glandular cells of undetermined significance and as high grade SIL., Conclusion: The AutoCyte Prep system affords excellent cellular presentations and superior sensitivity for SILs when compared to the conventional technique. The use of AutoCyte Screen, for primary screening demonstrated performance equivalent to manual screening, with a significant improvement in sensitivity when measured against biopsy results.

Objective: To compare the AutoCyte SCREEN (AutoCyte, Burlington, North Carolina, U.S.A.) system with manual screening by experienced cytotechnologists using thin-layer preparations that had been previously extensively studied and their cytologic abnormalities well defined., Study Design: AutoCyte PREP (AutoCyte) samples prepared for a previous split-sample study comparing thin-layer preparations to conventional smears were used. These 1,992 AutoCyte PREP samples were in a cohort the abnormal findings of which had been confirmed via independent review by two sets of pathologists. For the current study, these samples were remasked and evaluated by the AutoCyte SCREEN system in a clinical laboratory. The instrument scanned each slide and selected six overview fields and 120 single objects for storage and display. The computer classified each slide in one of the following categories: abnormal, uncertain, normal or unsatisfactory. Independently for each case, a cytotechnologist evaluated the six fields and 120 objects selected by the instrument as abnormal, normal or unsatisfactory. For those cases classified as uncertain by AutoCyte, the technologist then reexamined the cellular displays and entered a consensus classification. These results were then compared to those of an independent review by cytotechnologists of the identical set of slides using routine manual screening., Results: The AutoCyte SCREEN selected 35% of slides for manual review. Technologist and computer rendered equivalent classifications in 79%. Of the total slides screened by the AutoCyte SCREEN, 57% were classified as "uncertain," and 88% of these were subsequently classified as normal by consensus. Using the well-defined abnormal values of the cellular sample as a basis for calculation, the AutoCyte SCREEN-assisted practice had a diagnostic sensitivity of 85% and diagnostic specificity of 97.6%. Comparable values for manual screening of the identical cellular sample were a diagnostic sensitivity of 80% and specificity of 97.4%., Conclusion: The AutoCyte SCREEN achieves comparable or greater sensitivity in detecting cervical abnormalities in comparison with manual screening. When combined with the substantial advantage of thin-layer preparations over conventional smears, the AutoCyte SCREEN provides a screening system of superior sensitivity over conventionally prepared and examined cervical smears.

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.

Objective: To compare the CytoRich system with conventional cervical cytology in a university medical center hospital laboratory., Study Design: The CytoRich system combines liquid preservation, selective reduction of blood/inflammation, thin-layer preparation and discrete staining. Two thousand thirty-two parallel conventional and CytoRich samples were examined as part of a multicenter trial of the CytoRich/AutoCyte systems. Same-patient conventional and CytoRich slides were submitted to separate cytotechnologists blindly. The results were compared, and all nonmatching sample pairs were reviewed again. A consensus diagnosis was derived for all cases. The initial readings of the CytoRich and conventional smears were compared with each other and with the consensus diagnosis., Results: Of the 148 squamous intraepithelial lesions (SILs) found by either method, 85% were found by CytoRich, while only 58.5% were found by conventional smear. As compared with the consensus diagnosis, CytoRich slides had 86.7% sensitivity for SIL and 99.1% specificity, while the conventional slides had 63.6% sensitivity and 99.7% specificity. Consensus review resulted in upgrading to SIL in 1.8% of conventional slides and 1.4% of CytoRich slides. The biopsy correlation results were similar for the two methods., Conclusion: The CytoRich system affords excellent cellular presentations and superior sensitivity for SILs when compared to the conventional technique.