Is conventional urinary cytology still reliable for diagnosis of primary bladder carcinoma? Accuracy based on data linkage of a consecutive clinical series and cancer registry.

OBJECTIVE: Reported urine cytology accuracy, particular sensitivity, is highly variable. We evaluated the accuracy of urinary cytology for primary bladder cancer using population data linkage to provide valid estimates. STUDY DESIGN: Consecutive cytology tests processed through a major service between January 2000 and December 2004 were linked to a regional population cancer registry (allowing outcome ascertainment). Sensitivity and specificity were calculated using different thresholds, based on standardized reporting categories (C1 = negative, C2 = reactive, C3 = atypical, C4 = suspicious, C5 = malignant, Cx = inadequate). RESULTS: Cancer registry matching of 2,594 tests revealed 130 incident bladder cancers, of which 97 occurred within 12 months of cytology and were included in calculating accuracy. Sensitivity (C3-C5 considered positive) ranged between 40.2 and 42.3%, and specificity was 93.7-94.1%. If C3 results are counted as negative, sensitivity estimates reduced to 24.7-26.0%. The positive predictive value of a C3, C4 or C5 report was 11.7, 39.2, and 66.6%, respectively. High tumor grade was associated with significantly higher sensitivity compared to low and intermediate grades combined (p = 0.02). CONCLUSION: Urine cytology is highly specific but has intermediate sensitivity, indicating that it has a role in adjunct diagnosis, but not in screening for primary bladder cancer. C3 results should be considered 'positive' and further investigated, and all positive results should prompt further intervention.

Analysis of morphologic patterns of fine-needle aspiration of the breast to reduce false-negative results in breast cytology.

BACKGROUND: The identification of specific morphologic diagnostic criteria is of paramount importance to optimize the accuracy of fine-needle aspiration cytology (FNAC) and to reduce the rate of false-negative results. In the current study, the authors reviewed a consecutive series of false-negative findings observed in the study center to define the presence and degree of cytologic abnormalities. False-negative cases were randomly mixed with true-negative cases and were reviewed by a panel of expert readers in a blinded fashion. The main objective of the current study was to identify a morphologic pattern that may permit the reduction of false-negative findings while maintaining the specificity of FNAC. METHODS: A blind review of a set of 41 consecutive false-negative and 49 true-negative breast aspiration samples was performed by a panel of 10 expert cytologists who were asked to give a final report and to classify the samples according to classic morphologic parameters. RESULTS: The majority final report sensitivity was 54% (range, 19-61%) and specificity was 73% (range, 65-92%). The average concordance with the majority report, adjusted for chance agreement (kappa statistic), was moderate at 0.54 (range, 0.40-0.65). Enlarged nuclear size, a hyperchromatic nucleus, the absence of naked nuclei, and the absence of apocrine metaplasia were reported more frequently in carcinoma cases, although not to a significant extent. The only variable found to be associated significantly (P = 0.041) with a diagnosis of carcinoma was the presence of microcalcifications, which nevertheless were found to occur in only a minority of carcinoma cases (7 of 41 cases) or controls (2 of 49 controls). Multivariate analysis demonstrated that the presence of microcalcifications (odds ration [OR] of 3.0; 95% confidence interval [95% CI], 1.2-7.4), the absence of naked nuclei (OR of 2.4; 95% CI, 1.3-4.4), and enlargement of the nucleus (OR of 1.9; 95% CI, 1.1-3.4) were all independently associated with false-negative findings. Diagnostic accuracy using a morphology-based score did not appear to improve the results substantially compared with the final report (sensitivity of 0.46 vs. 0.54 [P = 0.508] and a specificity of 0.80 vs. 0.73 [P = 0.218]). CONCLUSIONS: The results of the current study confirm that breast FNAC false-negative results are at least partially the result of underreporting of abnormalities that may be noted at review. Detailed analysis of a single morphologic characteristic was found to be of limited diagnostic value, suggesting that operators do perceive abnormalities but cannot translate these findings into distinct morphologic categories.

A feasibility study of the use of the AutoPap screening system as a primary screening and location-guided rescreening device.

BACKGROUND: The AutoPap 300 QC system (Tripath Imaging, Inc., Burlington, NC) is an automated device that was designed to screen conventionally prepared cervical smears and, more recently, thin-layer slide preparations. The system has been tested in large clinical trials. METHODS: A total of 14,145 cervical smears obtained from participants in the Florence screening program were eligible for the study. Smears were processed first with the AutoPap system and were classified into three different categories: 1) no further review (NFR), 2) review, and 3) process review (PR). Conventional manual reading was performed by 10 experienced cytopathologists. RESULTS: After AutoPap processing, 2398 smears were classified as NFR (16.9%), and 1818 smears were classified as PR (12.8%). Overall, there were 188 inadequate smears (1.3%) at conventional review and 125 inadequate smears (0.88%) at AutoPap review. Six-month repeat smears were prompted by 330 conventional reviews (2.3%) and by 222 AutoPap reviews (1.56%). Similarly, referral to colposcopy was prompted by 179 conventional reviews (1.2%) and by 147 AutoPap reviews (1.0%). Overall, 32 patients were diagnosed with high-grade cervical intraepithelial neoplasia as a result of assessment. Conventional reading detected 31 patients (28 patients were referred for colposcopy, and 3 patients were referred for repeat cytology), and the AutoPap system detected 30 patients (27 patients were referred for colposcopy, and 3 patients were referred for repeat cytology). CONCLUSIONS: The current experience suggested that conventional reading and AutoPap reading of cervical smears had essentially the same sensitivity, with slightly greater specificity for the AutoPap system. Thus, comparisons of the AutoPap system and conventional reading should focus mainly on cost analysis.