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

Abstract

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.

Value of p16INK4a in the diagnosis of low‐grade urothelial carcinoma of the urinary bladder in urinary cytology

“…Nevertheless, a cytological diagnosis of atypia should prompt the search for a high‐grade urothelial carcinoma. The reported sensitivity of urine cytology for low‐grade urothelial carcinomas ranges from 16.7% to 49%,9, 19, 20 but in the present series it was only 2%. This discrepancy may be because most of the cases were considered to show too few changes or to contain an insufficient number of suspicious cells to allow a conclusive diagnosis of malignancy, and were thus reported as negative.…”

Clinical Value of Dividing False Positive Urine Cytology Findings into Three Categories: Atypical, Indeterminate, and Suspicious of Malignancy

“…Several reports have shown that assuming class III reports to be positive instead of negative improves sensitivity while maintaining acceptable specificity. (Whisnant et al, 2003;Deshpande et al, 2005;Turco et al, 2011) Although the design of the current study did not allow us to draw a similar conclusion from our data, our findings support this notion, at least for the category of suspicious of malignancy.…”

Applying the Paris System for Reporting Urine Cytology Increases the Rate of Atypical Urothelial Cells in Benign Cases: A Need for Patient Management Recommendations

“…Other authors have pointed out the need to consider an atypical result as potentially malignant, recommending further investigation for patients [14] .…”