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Comparative Study
. 2020 Nov;48(11):1034-1040.
doi: 10.1002/dc.24530. Epub 2020 Jun 20.

Predictive value of MCM5 (ADXBLADDER) analysis in urine of men evaluated for the initial diagnosis of bladder cancer: A comparative prospective study

Emanuela Anastasi  1 , Martina Maggi  2 , Sara Tartaglione  1 , Antonio Angeloni  3 , Giuseppina Gennarini  1 , Pier Paolo Leoncini  4 , Isabella Sperduti  5 , Giovanni Di Lascio  2 , Virgilio De Stefano  2 , Giovanni Battista Di Pierro  2 , Francesco Del Giudice  2 , Gian Maria Busetto  2 , Ettore De Berardinis  2 , Alessandro Sciarra  2
Affiliations
Comparative Study

Predictive value of MCM5 (ADXBLADDER) analysis in urine of men evaluated for the initial diagnosis of bladder cancer: A comparative prospective study

Emanuela Anastasi et al. Diagn Cytopathol. 2020 Nov.

Abstract

Background: To compare predictive value of MCM5 to urinary cytology (UC) for the primary diagnosis of bladder cancer (BCa).

Methods: We prospectively enrolled 91 patients who presented macroscopic hematuria or persistent lower urinary tract symptoms at our institution. Single voided mid-stream urine specimens were collected for UC and MCM5 (ADXBLADDER; Arquer Diagnostics Ltd, Sunderland, United Kingdom) assessment. Cystoscopy was used as confirmatory test, and positive cases underwent transurethral resection of bladder tumor with histopathological evaluation.

Results: Forty cases (43.9%) showed a positive cystoscopy for BCa. Histology was obtained in 37 cases: 16 (43.2%) high-grade (HG) and 21 (56.8%) low-grade (LG) transitional cell carcinoma (TCC). UC had a sensitivity of 62.5%, specificity of 86.3%, PPV of 78.1% and NPV of 74.6%. Sensitivity, specificity, PPV and NPV of MCM5 were 60.0%, 88.2%, 80.0% and 73.8%, respectively. According to tumor grade, MCM5 and UC showed a sensitivity of 47.6% and 52.4% in LG, and 87.5% and 75.0%, respectively, in HG TCC. False-positive rates were 11.8% and 13.7% of negative cases for BCa with MCM5 and UC test, whereas false-negative results were found in 40.0% and 37.5% of BCa cases, respectively. The combination of the two tests showed a sensitivity of 71.4% in LG, and 93.8% in HG TCC.

Conclusion: In the present analysis, MCM5 showed lower sensitivity than UC in predicting BCa primary diagnosis. According to tumor grade, MCM5 showed a higher sensitivity in the detection of HG BCa compared to UC, although values were not significantly different.

Keywords: MCM5; bladder cancer; cytology; high grade urothelial carcinoma; urinary markers.

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References

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