NMP 22, BTA stat Test and Cytology in the Diagnosis of Bladder Cancer: A Comparative Study

Abstract

Objective: To evaluate the usefulness of the NMP 22 and BTA stat test in the diagnosis and follow-up of bladder cancer and to compare these tests to cytology and cystoscopy, routine diagnostic methods. Methods: 150 patients followed up for bladder cancer or symptoms suggestive of bladder cancer underwent cystoscopy after cytology, NMP 22 and BTA stat test using a recently voided urine sample. In suspect cases, TUR and histopathological analysis were performed. Results: Bladder cancer was proven in 76 patients and excluded in 74. For NMP 22 we have used the cutoff value recommended by the manufacturer (10 U/ml) and that obtained by our receiver-operating characteristic curve (6 U/ml). Sensitivity was 84.21% for NMP 22 at the cutoff value of 6 U/ml and 76.32% with 10 U/ml; 72.37% for BTA stat test; 69.74% for cytology, and 100% for cystoscopy. Specificity was 86.49% for NMP 22 at a cutoff value of 6 U/ml and 90.54% at 10 U/ml; 89.19% for the BTA stat test; 93.24% for cytology and 89.19% for cystoscopy. NMP 22 sensitivity for grades 1, 2, and 3 was 68.75, 75.86 and 100%, respectively, at a cutoff value of 6 U/ml, and 50, 68.97 and 96.77%, respectively, at a cutoff level of 10 U/ml; for BTA stat the sensitivity was 56.25% in G1, 62.07% in G2 and 90.32% in G3, and for cytology the sensitivity was 43.75, 62.07 and 90.32%, respectively. The sensitivity of NMP 22 was 68.75% in stage Ta, 84.78% in T1 and 100% in T2–T4 at a cutoff level of 6 U/ml and 50, 80.43 and 92.86%, respectively, at a cutoff level of 10 U/ml; BTA stat sensitivity was 50% in Ta, 73.91% in T1 and 92.86% in T2–T4; and in cytology the results were 37.50, 73.91 and 85.71%, respectively. Using the McNemar test, there was only a significant difference between the sensitivity of NMP 22 at a cutoff level of 6 U/ml and cytology in the overall sample. Conclusions: The high sensitivity of the NMP 22 and BTA stat test in combination with the data obtained from the parameters used for the evaluation of the test demonstrate their usefulness in the diagnosis and follow-up of bladder cancer. NMP 22 at a cutoff value of 6 U/ml is significantly more sensitive than cytology and consequently a thoroughly valid diagnostic tool in the diagnosis of bladder cancer which may substitute voided urine cytology.

Bladder tumor markers: from hematuria to molecular diagnostics – where do we stand?

“…In his study, cytology had a greater than 92% sensitivity and specificity [28]. These results echo the findings of a large number of authors who have published data reporting sensitivities between 8 and 89%, and specificity between 50 and 70% [13,29–31]. In healthy individuals, the specificity is improved, however, in patients with a history of benign urologic conditions; for example, in BPH and nephrolithiasis, it drops precipitously [32,33].…”

“…The specificity of the ELISA was reported to be between 60 and 80% [36,37]. These values depend on the concentration of the marker used as the cutoff limit, in order to infer a positive test result [38,39]. Sharma et al .…”

A Multigene Urine Test for the Detection and Stratification of Bladder Cancer in Patients Presenting with Hematuria

“…Several tests have received Food and Drug Administration approval, although none has sufficient accuracy to routinely displace cytology. [1][2][3][4][5][6] We recently developed a multiplex mRNA assay (uRNA) for the diagnosis and stratification of urothelial cancer that uses polymerase chain reaction amplification to quantify 4 mRNAs from unfractionated urine. 7 The method uses 2 linear discriminate algorithms to combine raw data from the individual markers.…”

Comparative Analysis of Gender-Related Differences in Symptoms and Referral Patterns prior to Initial Diagnosis of Urothelial Carcinoma of the Bladder: A Prospective Cohort Study

“…Bassi et al [25] stated that most of the markers tend to be less specific but more favorable in terms of sensitivity compared to urinary cytology. Another comparative study focusing on NMP22, BTA stat test and cytology ascribed NMP22 a higher sensitivity than cytology [26]. Sagnak et al [27] recommend NMP22 as a cost-effective method in combination with upper tract ultrasonography instead of urine cytology for low-risk patients with asymptomatic microscopic hematuria.…”