Search

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.

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.

To thrive in a world of managed care and capitation, knowing the cost of production is critical, especially in cervical cytology. The relative costs of production for preparation and interpretation of cervical cytology for conventional manually read smears and a primary automated screening method were calculated in a university practice setting. The components were disposables, processing, screening, pathologist review, capital equipment, and facilities cost. The production cost for a conventional smear in our laboratory is $9.75, and the comparable production cost by a primary screening automated method would be $12.07, if it were approved for primary screening. Based on these calculations, an interactive automated method approved for primary screening would cost slightly more than conventional testing. Combinations of conventional and automated examinations (secondary screening systems) are not cost feasible unless the additional production expense can be passed through to the payers.