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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.

Objective: To study the cellularity of liquid-based preparations (LBPs) for normal, abnormal and false negative cervical cytology cases., Study Design: A series of 1,875 LBPs obtained by a split-sample protocol was examined. Slides had been examined by at least one cytotechnologist. All abnormals were reviewed by at least two cytopathologists. The cellular objects were counted using a fully automated microscope. Cellularity was evaluated for the entire population, normal (< LSIL) slides, abnormal (LSIL+) slides and "false negative" slides. False negatives were identified as those with an initial impression of < LSIL and (1) the reference pathologist's impression of the slide was LSIL+, (2) the simultaneous conventional smear was LSIL+, or (3) a cervical biopsy was LSIL+. Descriptive statistics and graphic comparisons were used., Results: There were 192 confirmed abnormal cases and 1,683 normal cases, of which 53 were false negative. The frequency distributions of cellularity for the entire population and each category were skewed-right nonnormal. Median cell counts of the entire series, normals, abnormals and false negatives were 60,510, 59,822, 70,523 and 64,036 respectively. Cell counts at 2.5 percentiles were 8,677, 7,891, 11,864 and 6,009, respectively. The population of abnormal slides tended to have higher cellularity. The population of false negative slides could not be distinguished by their cellularity., Conclusion: Cellularity does not provide assurance of adequacy. Any cellularity criterion should be based on measurement of the prevalence of abnormal cells on abnormal slides.

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.

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 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 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.

Objective: To compare the performance of liquid-based cell preparations from the AutoCyte PREP system (AutoCyte, Inc., Elon College, North Carolina) with the conventional cervical smear in masked, split-sample, multisite trials., Study Design: The AutoCyte PREP system utilizes the CytoRich method, which combines liquid preservation, selective reduction of blood and inflammation, thin-layer cell dispersion and discrete staining. In an eight-site multicenter trial, 8,983 cases were evaluated. Parallel AutoCyte PREP slides and matching conventional cervical cytologic smears were screened in a masked fashion, with all abnormals reviewed in a masked, on-site pathologist review. The conventional smear was always prepared first, with the AutoCyte PREP using the residual cells on the collection device. The Bethesda System was used for reporting diagnosis and specimen adequacy., Results: Of the cases, 7,805 (86.9%) had the same interpretation. In 8,750 cases (97.4%), there was agreement within one diagnostic category. The AutoCyte PREP demonstrated a statistically significant, 31% overall improvement in the detection of squamous intraepithelial lesion and invasive cancer when evaluating cases with more than one diagnostic class difference. Biopsy correlation of available data supported the improvement observed in the cytology-based comparison. Recovery of infectious organisms and endocervical component was comparable between preparations, especially in light of the split-sample study design. There was a 39% reduction in unsatisfactory slides and 44% fewer satisfactory but limited by reports., Conclusion: The AutoCyte PREP and CytoRich method produce excellent cellular presentations with standardized quality, superior sensitivity and improved adequacy as compared to the conventional method.

Objective: Second cervical smears obtained at short time intervals often exhibit a lesser degree of abnormality than the first smear. We studied the effect of time interval between smears on diagnoses in two large, distinctive cohorts., Study Design: Patients with two or more satisfactory smears with at least one smear or a cervical biopsy showing atypical squamous cells of undetermined significance or greater were selected. Patients were divided into four subsets by test intervals (days) (< or = 45, 46-90, 91-120, > 120) and compared statistically., Results: The distribution of differences between results for the short-interval subsets (< 120) was significantly different (P < .01) from the interval subset > 120 days. At short intervals the results revealed loss of sensitivity in the second smear as compared to the initial smear and concurrent biopsies., Conclusion: Rapidly repeated cervical smears show poor agreement with the biopsy and may be misleading. This effect is most pronounced when the interval is < 45 days. Colposcopists should consider whether concurrent smears shortly after an abnormal smear are worth performing, given the loss of sensitivity.

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.