BladderChek Test Research Articles

An ensemble approach of urine sediment image analysis and NMP22 test for detection of bladder cancer cells.

BackgroundBladder cancer is the eighth most common cancer and the second most common urological cancer in Korean males. Current diagnostic tools for bladder cancer include cystoscopy (an upper tract study), urine cytology, and nuclear matrix protein 22 (NMP22) test. In this study, we evaluated the detection rate of atypical/malignant urothelial cells in urinary sediment images when flagged for positive NMP22 test.MethodsNMP22 was measured by NMP22 BladderChek Test (Abbott Laboratories) and urine chemical and sediment analysis were performed by fully automated cobas 6500 urine analyzer (Roche Diagnostics). Specimens that met the manual microscopic examination (MME) criteria were then subjected to an on‐screen review of images. We subsequently reviewed sediment images and examined under the microscopy for the flagged cases.ResultsOf the 1217 patients, 345 (28.3%) had positive NMP22 results, whereas 872 (71.7%) had negative results. Out of the positive results, 154 (12.7%) were positive and 191 (15.7%) weakly positive for NMP22. Screened review of flagged specimens (ie, positive NMP22 result) with sediment imaging analysis revealed that suspicious urothelial carcinoma cells were detected in only two cases (0.8%). In the NMP22 negative flagged cases, the suspicious neoplastic cells were not found.ConclusionsOur findings suggest that the NMP22 test should be added to the flagging criteria for MME to improve diagnostic accuracy. The combination of urine sediment imaging analysis and NMP22 test can significantly assist technicians in the review of specimens.

Use of the Nuclear Matrix Protein 22 BladderChek Test for the Detection of Primary and Recurrent Urothelial Carcinoma.

Objective To evaluate the performance of the nuclear matrix protein 22 (NMP22) BladderChek test in urothelial carcinoma (UC). Methods We retrospectively analyzed 1318 patients who performed the NMP22 BladderChek tests. Of them, 103 were primary UC patients, 90 were surgical treatment UC patients, and 1125 were benign disease patients. The performance of the NMP22 BladderChek test for the diagnosis of primary and recurrent UC was evaluated. Moreover, the performance of urine cytology and the NMP22 BladderChek test for the diagnosis of primary UC was compared in 90 available subjects including 48 primary UC patients and 42 benign disease patients. Results The sensitivity and specificity of the NMP22 BladderChek test were 37.9% and 95.8%, respectively, for the diagnosis of primary UC (n = 1228). The corresponding parameters of the NMP22 BladderChek test were 31.0% and 88.5%, respectively, for the diagnosis of recurrent UC (n = 90). The sensitivity and specificity of urine cytology were 54.2% and 97.6%, respectively, for the diagnosis of primary UC (n = 90); the corresponding parameters of the NMP22 BladderChek test were 41.7% and 83.3%, respectively; the corresponding parameters of the two tests combination were 64.6% and 83.3%, respectively. There was a significant difference in the performance between the NMP22 BladderChek test and urine cytology or the combination of two tests (P = 0.017 and 0.001, respectively). Conclusions The NMP22 BladderChek test has a low sensitivity for detecting primary and recurrent UC. Urine cytology is superior to the NMP22 BladderChek test, and combined use of the two tests improves the sensitivity in the detection of primary UC.

Evaluation of the NMP22 BladderChek test for detecting bladder cancer: a systematic review and meta-analysis.

BackgroundWe examined the usefulness of the nuclear matrix protein 22 (NMP22) BladderChek test for detecting bladder cancer.Materials and MethodsA literature search was performed using PubMed, Embase, the Cochrane Library, and Web of Science. The diagnostic accuracy of the NMP22 BladderChek test was evaluated via pooled sensitivity, specificity, positive likelihood ratio (PLR), negative likelihood ratio (NLR), diagnostic odds ratio (DOR), and area under curve (AUC). Inter-study heterogeneity was explored using meta-regression and subgroup analyses.ResultsWe included 23 studies in the systematic review and 19 in the quantitative meta-analysis. Overall sensitivity and specificity were 56% (52–59%) and 88% (87–89%), respectively; pooled PLR and NLR were 4.36 (3.02–6.29) and 0.51 (0.40–0.66), respectively; DOR was 9.29 (5.55–15.55) with an AUC of 0.8295. The mean sensitivity for Ta, T1, ≥ T2, Tis, G1, G2, and G3 disease was 13.68%, 29.49%, 74.03%, 34.62%, 44.16%, 56.25%, and 67.34%, respectively.ConclusionsThe NMP22 BladderChek test shows good discrimination ability for detecting bladder cancer and a high-specificity algorithm that can be used for early detection to rule out patients with higher bladder cancer risk. It also has better potential for screening higher-grade and higher-stage tumors, and better diagnostic performance in Asians.

Diagnostic Potential of Urinary α1-Antitrypsin and Apolipoprotein E in the Detection of Bladder Cancer

The ability to reliably diagnose bladder cancer in voided urine samples would be a major advance. Using high throughput technologies, we identified a panel of bladder cancer associated biomarkers with potential clinical usefulness. In this study we tested 4 potential biomarkers for the noninvasive detection of bladder cancer. We examined voided urine specimens from 124 patients, including 63 newly diagnosed with bladder cancer and 61 controls. Concentrations of proteins were assessed by enzyme-linked immunosorbent assay, including α1-antitrypsin, apolipoprotein E, osteopontin and pentraxin 3. Data were compared to the results of urinary cytology and the BTA Trak® enzyme-linked immunosorbent assay based bladder cancer detection assay. We used the AUC of ROC curves to compare the usefulness of each biomarker to detect bladder cancer. Urinary levels of α1-antitrypsin, apolipoprotein E and bladder tumor antigen were significantly increased in subjects with bladder cancer. α1-Antitrypsin (AUC 0.9087, 95% CI 0.8555-0.9619) and apolipoprotein E (AUC 0.8987, 95% CI 0.8449-0.9525) were the most accurate biomarkers. The combination of α1-antitrypsin and apolipoprotein E (AUC 0.9399) achieved 91% sensitivity, 89% specificity, and a positive and negative predictive value of 89% and 90%, respectively. Multivariate regression analysis highlighted only apolipoprotein E as an independent predictor of bladder cancer (OR 24.9, 95% CI 4.22-146.7, p = 0.0004). Alone or in combination, α1-antitrypsin and apolipoprotein E show promise for the noninvasive detection of bladder cancer (OR 24.9, 95% CI 4.22-146.7, p = 0.0004). Larger, prospective studies including more low grade, low stage tumors are needed to confirm these results.

In the cystoscopic follow-up of non-muscle-invasive transitional cell carcinoma, NMP-22 works for high grades, but unreliable in low grades and upper urinary tract tumors

Two percent of the bladder non-muscle-invasive (NMI) transitional cell carcinomas (TCC) are associated with upper urinary tract (UUT) TCC. We evaluated the role of nuclear matrix protein-22 (NMP-22) (BladderChek) test in the diagnosis of lower urinary tract and UUT-TCC. From March 2009 to June 2011, 122 patients with bladder NMI-TCC underwent 205 control cystoscopy. A total of 95 (78 men and 17 women, mean age 60.7 years, range, 27-88) patients who were followed regularly with NMP-22 test and with follow-up cystoscopies (145 episodes; min. 1-max. 5) were included in this study. For routine monitoring of the UUT, IVU or CT urography was used once a year for high grades (HG), and once in every other year for low grades (LG). The sensitivity and specificity of NMP-22 were evaluated by ROC curves, and sensitivity, specificity, and positive and negative predictive values were calculated. Chi-square test was used for the differences between the subgroups. Cystoscopy and NMP-22 results of the patients included in the study revealed the sensitivity (44.4%) of the test was very low and the specificity (98.4%) was quite high (p < 0.001). Among the 10 cystoscopies where NMP-22 was negative, but cystoscopy was positive for tumor, 8 had LG and 2 had HG TCC. NMP-22 was never positive in low-grade tumors, in other words, all of the NMP-22-positive 8 tumors were high grade. On the other hand, in 20% (2/10) of the cases, NMP-22 can be negative although the tumor was high grade. Two (2.1%) HG UUT-TCC were detected in 95 patients. These 2 patients were within the 125 cystoscopies (75 patients) where both NMP-22 and cystoscopy were negative for tumor. Nuclear matrix protein-22 cannot detect LG TCC. However, it detects overwhelming majority of HG TCC. For this reason, positive NMP-22 test largely indicates HG TCC. NMP-22 is also not reliable in UUT-TCC, even in HG tumors.

Editorial Comment

This prospective study evaluated the performance of the NMP22 BladderChek test in a large single-center study. The study had surprising results, considering the low sensitivity for BladderChek for high-grade tumors (42%) compared with several prospective multicenter studies that found the sensitivity of the test for high-grade disease to be over 70%. 1 Grossman H.B. Messing E. Soloway M. et al. Detection of bladder cancer using a point-of-care proteomic assay. JAMA. 2005; 293: 810-816 Crossref PubMed Scopus (289) Google Scholar , 2 Grossman H.B. Soloway M. Messing E. et al. Surveillance for recurrent bladder cancer using a point-of-care proteomic assay. JAMA. 2006; 295: 299-305 Crossref PubMed Scopus (215) Google Scholar Furthermore, the specificity of BladderChek in this study at 96.7% was significantly higher than previous marker studies. Although variability in the performance of the laboratory NMP22 test has been reported, the point-of-care test, which uses a standardized cutoff of 10 U/mL, would not be expected to have significant variation. 3 Shariat S.F. Marberger M.J. Lotan Y. et al. Variability in the performance of nuclear matrix protein 22 for the detection of bladder cancer. J Urol. 2006; 176 ([Discussion:926]): 919-926 Abstract Full Text Full Text PDF PubMed Scopus (83) Google Scholar The reasons for the discrepancies between this and previous studies are not clear and are important to determine how to interpret this study. Use of the NMP22 BladderChek Test in the Diagnosis and Follow-Up of Urothelial Cancer: A Cross-sectional StudyUrologyVol. 77Issue 1PreviewTo investigate the efficacy of the nuclear matrix protein (NMP) 22 BladderChek test (NMP22BC) in the detection and follow-up of urothelial carcinoma. Full-Text PDF

Use of the NMP22 BladderChek Test in the Diagnosis and Follow-Up of Urothelial Cancer: A Cross-sectional Study

To investigate the efficacy of the nuclear matrix protein (NMP) 22 BladderChek test (NMP22BC) in the detection and follow-up of urothelial carcinoma. A total of 1021 patients who underwent the NMP22BC, cytology, and cystoscopy, were studied. We divided the patients into 2 groups: group I consisted of 597 patients who were being followed up for previous urothelial carcinoma, and group II consisted of 424 patients with hematuria. The sensitivity and specificity of the NMP22BC, cytology, and the combination (NMP22BC + cytology) were compared. Of the 1021 patients, 131 were diagnosed with urothelial cancer. The overall sensitivities for the NMP22BC, cytology, and the combination were 32.1%, 38.2%, and 52.7%, respectively. In group I, the sensitivity of the NMP22BC was lower than the sensitivity of cytology (22.58% vs 35.5%); there was no difference between the sensitivity of the NMP22BC and that of cytology in group II (40.58% vs 40.58%). For the combination, the sensitivity was greater than that of either test alone in both groups (46.77% and 57.97% in groups I and II, respectively). The sensitivity of the NMP22BC was greater than that of cytology (22.6% vs 13.2%) for low-grade bladder cancer. The NMP22BC has lower sensitivity than cytology. However, the sensitivity of NMP22BC in low-grade tumors was higher than that of cytology. Therefore, when the NMP22BC is combined with cytology, the sensitivity for detecting urothelial carcinoma is increased, which implies that this combination may be useful in the screening and follow-up of urothelial carcinoma.

1169 URINE CYTOLOGY PROVIDES NO ADDITIONAL DIAGNOSTIC VALUE IN PATIENTS WITH A NEGATIVE CYSTOSCOPY AND NEGATIVE NMP22 BLADDERCHEK TEST FOR THE DETECTION OF TRANSITIONAL CELL CARCINOMA OF THE BLADDER

You have accessJournal of UrologyBladder Cancer: Detection and Screening1 Apr 20101169 URINE CYTOLOGY PROVIDES NO ADDITIONAL DIAGNOSTIC VALUE IN PATIENTS WITH A NEGATIVE CYSTOSCOPY AND NEGATIVE NMP22 BLADDERCHEK TEST FOR THE DETECTION OF TRANSITIONAL CELL CARCINOMA OF THE BLADDER John Terrell, Keren Elias, Chester Donnally, Richard Ho, Arthur Sagalowsky, and Yair Lotan John TerrellJohn Terrell More articles by this author , Keren EliasKeren Elias More articles by this author , Chester DonnallyChester Donnally More articles by this author , Richard HoRichard Ho More articles by this author , Arthur SagalowskyArthur Sagalowsky More articles by this author , and Yair LotanYair Lotan More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2010.02.669AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Urine cytology (UC) is an imperfect diagnostic adjunct to cystoscopy (cysto) for the detection of transitional cell carcinoma (TCC). It suffers from a low sensitivity, increased expense, delay in result availability and frequent inconclusive findings. Urine markers have the potential of providing improved negative predictive value (NPV), immediate results and decreased cost. We examined 3 prospective multi-institutional studies with a cohort of almost 2500 patients (pts) to ascertain whether UC provides any additional diagnostic role in pts with both a negative NMP22 BladderChek test (BC) and a negative cysto. METHODS Initially we performed subset analyses of 2 large prospective multi-center databases evaluating the point-of-care NMP22 BladderChek test for bladder cancer detection (n=1331, Grossman HB, et al. JAMA 2005) and surveillance (n=668, Grossman HB, et al. JAMA 2006). These cohorts were analyzed for the presence of cancer and the result of UC in the setting of a negative cysto and BC to determine if UC would have provided a diagnostic role. Subsequently, the results were validated in a prospective cohort of 434 pts at our institution who had a BC test prior to evaluation. RESULTS In the detection database of 1331 pts, there were 1065 pts with a negative cysto and BC. There were only 3 cancers (stages Ta, Tis and T1) in this group. UC was atypical in one and reactive in 2 pts. In the surveillance cohort of 668 pts, there were 437 pts with a negative cysto and BC. Cancer was found in 2 pts (stages Tis and Ta). There was one atypical and one reactive UC in these 2 pts. Subsequent validation of these results in our cohort of 434 pts, in which 288 pts had a negative cysto and BC, revealed the presence of only one cancer. The one tumor was a Ta ureteral TCC with a reactive UC. Of the 6 pts with cancer out of 1790 pts, none had a positive UC. CONCLUSIONS In both the subset analyses of the multi-institutional studies evaluating BC and the prospective study at our institution, UC provided no additional diagnostic information for the detection of TCC in pts with a negative cysto and BC. There were very few cancers missed with only 6 in 1790 pts. The use of a point-of-care test in conjunction with cysto in lieu of cytology could decrease cost, provide immediate results, improve NPV and reduce the uncertainty that results from inconclusive cytologic results. Dallas, TX© 2010 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 183Issue 4SApril 2010Page: e453 Advertisement Copyright & Permissions© 2010 by American Urological Association Education and Research, Inc.MetricsAuthor Information John Terrell More articles by this author Keren Elias More articles by this author Chester Donnally More articles by this author Richard Ho More articles by this author Arthur Sagalowsky More articles by this author Yair Lotan More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

Usefulness of the NMP22BladderChek Test for Screening and Follow-up of Bladder Cancer

PurposeWe evaluated the usefulness of the nuclear matrix protein 22 BladderChek (NMP22BC) test for the screening and follow-up of bladder cancer.Materials and MethodsFrom February 2006 to September 2009, we enrolled 1,070 patients who had hematuria or who were being followed up for bladder cancer. We compared the sensitivity and specificity of the NMP22BC test with those of urine cytology.ResultsThe sensitivity of the NMP22BC test (77.5%) was significantly higher than that of urine cytology (46.3%). The specificity of the NMP22BC test was 88.8%, compared with 97.9% for urine cytology. The sensitivity of the NMP22BC test (81.8%) in non-muscle-invasive bladder cancer was higher than that of cytology (36.4%). However, the sensitivity of the NMP22BC test and of urine cytology in invasive bladder cancer were 57.1% and 92.9%, respectively. The sensitivity of the NMP22BC test was higher for low-grade bladder cancer (83.9%) than for high-grade (62.5%), and the sensitivity of cytology was higher for high-grade bladder cancer (66.7%) than for low-grade (37.5%). Follow-up bladder cancer was detected in 262 patients. The sensitivity of the NMP22BC test in that group (72.7%) was decreased and the specificity (91.7%) was increased. The sensitivity of cytology (54.5%) in the follow-up group was increased and the specificity (95.6%) was decreased. The presence of pyuria was significantly associated with the lower specificity of the NMP22BC test.ConclusionsThe greater sensitivity of the NMP22BC test may be more useful for the diagnosis of non-muscle-invasive bladder cancer and low-grade bladder cancer than for the diagnosis of invasive or high-grade bladder cancer. If the NMP22BC test is performed in the absence of pyuria, it may play a compensatory role for urine cytology.

The Use of NMP22 and Urine Cytology for the Surveilance of Patients with Superficial Bladder Cancer

Aim To see if NMP22 combined with urine cytology can safely increase the interval between cystoscopies in the surveillance of superficial bladder cancers. Methods Thirty four patients with low grade superficial bladder transitional cell carcinomas were prospectively recruited and followed up with regular flexible cystoscopies over 2 years. Freshly voided urine was collected for urine cytology and NMP22 test prior to cystoscopy. Patients with suspicious cystoscopy findings or suspicious cytology underwent biopsies and/or resection of the suspicious lesions. Results 172 urine samples were collected and analyzed. The NMP 22 results were compared with voided urine cytology, cystoscopy and histological findings. Using the 10U/ml cutoff for quantitative measurement, the sensitivity, specificity, positive and negative predictive values of urinary NMP22 were 50%, 90.7%, 21.0%, and 97.3% respectively. When combined with voided urine cytology, the sensitivity, specificity, positive and negative predictive values were 71.4%, 88.5%, 25.0%, and 98.3% respectively. In comparison, the sensitivity, specificity, positive and negative predictive value of cystoscopy were 85.7%, 97.6%, 66.7%, and 99.2% respectively. Analysis with a receiver operating characteristic(ROC) curve found the ideal threshold of determinance of NMP22 for the detection of recurrences is 8.5U/ml with 100% sensitivity and 73.9% specificity. In our center, replacing alternate cystoscopy examination at 3,9,18 and 30 months with NMP22, results in a cost saving USD$740 or 37% per patient over 5 years. In the event of false positives, the patient will revert to the current surveillance schedule, with no increased costs incurred. Conclusion We propose that the optimal cutoff value for NMP22 is 8.5U/ml. At this level. the combination of the NMP22 BladderChek test and voided urine cytology is a sensitive non-invasive alternative to cystoscopy in the surveillance of patients who have had superficial low grade bladder cancer.

Usefulness of NMP22 as an adjunct to a typical urine cytology and low‐grade urothelial carcinoma

The usefulness of urine cytology combined with NMP22 was evaluated for the primary diagnosis of urothelial carcinoma. Of 53 clinically suspected patients, histopathological diagnoses were low-grade urothelial carcinoma (25), high-grade urothelial carcinoma (13), and inflammatory lesions (15). Cytology was positive in 25 and negative in 14 patients. Fourteen of 25 low-grade urothelial carcinoma and 11/13 high-grade urothelial carcinoma were diagnosed correctly on urine cytology. Atypical cells seen in 14 patients were categorized as inconclusive for malignancy. The overall sensitivity of urine cytology was 65.8%, whereas specificity was 100%. NMP22 was positive in 33 patients. Of these 30, 18 low-grade and 12 high-grade lesions were true positive. Of the 20 NMP22, eight negative cases were false-negative. Ten of 15 with negative histopathology were also negative for NMP22, three were false-positive, and two showed erratic results. Nine of 14 cases with atypical urine cytology were positive for NMP22. Eight of these showed low-grade carcinoma on histopathology. The sensitivity of BladderChek NMP22 test was 79%, whereas specificity was 80%. NMP22 BladderChek test is a useful adjunct to urine cytology in atypical and low-grade carcinoma.

MP-2.26: Urinary NMP22 BladderChek Test in Diagnosis of Bladder Cancer and Comparison with Urinary Cytology and Cystoscopic Biopsy

MP-2.26: Urinary NMP22 BladderChek Test in Diagnosis of Bladder Cancer and Comparison with Urinary Cytology and Cystoscopic Biopsy

The Use of the NMP22 BladderChek Test for Bladder Cancer to Optimise Investigations in a One-Stop Haematuria Clinic

Objective: We assessed the value of the NMP22 BladderChek point-of-care (POC) test (Kyowa Hakko UK Ltd., Slough, UK) in a one-stop haematuria clinic to optimise the choice of further investigations. Patients and methods: Over 34 months from 2005 until 2007, 590 patients presenting to a haematuria clinic were initially assessed with the NMP22 POC test. Patients with a positive NMP22 were counselled and offered further investigation with upper tract imaging and a general anaesthetic cystoscopy without first undergoing flexible cystoscopy (FC). The sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of the NMP22 POC test in this setting were calculated. The financial impact of this policy was assessed. Results: In total 58 of 590 men were NMP22 positive. Urothelial malignancy was identified in 22 patients and 5 had a non-urothelial malignancy of the genitourinary system. The sensitivity of the NMP22 test in detecting urothelial malignancy in newly presenting patients was 56.4%, specificity 93.5%, PPV 38.0% and NPV 97.0%. Eleven had no abnormality and none have subsequently developed a malignancy. The number of patients requiring FC fell by 10% resulting in significant financial savings. Conclusion: The NMP22 POC test can be used as the first test in a haematuria clinic to optimise the choice of subsequent investigations resulting in financial savings.

Impact of risk factors on the performance of the nuclear matrix protein 22 point‐of‐care test for bladder cancer detection

To evaluate the impact of different risk factors and symptoms on the performance characteristics of the nuclear matrix protein 22 (NMP22) BladderChek test (Matritech Inc., Newton, MA, USA) for the detection of bladder cancer, as this is a point-of-care assay that measures NMPs in voided urine. In all, 23 academic, private practice and veterans' facilities in 10 states prospectively enrolled consecutive patients from September 2001 to May 2002. Participants included 1328 patients at elevated risk of bladder cancer from factors such as a history of smoking or symptoms including haematuria and/or dysuria. Patients at risk of malignancy of the urinary tract provided a voided urine sample for analysis of NMP22 protein and cytology before cystoscopy. Of the 1328 patients: no urinary disease, benign disease and malignancy were found in 545 (41%), 704 (53%) and 79 (6%) patients, respectively. Overall, the positive predictive value (PPV) for detection of bladder cancer was 20.3% (45/222) and negative predictive value (NPV) was 96.9% (1072/1106). The PPV was higher in men (24.0%) than women (13.2%). In men, the PPV increased with smoking (35.4%), gross haematuria (51.2%) and a combination of both factors (70.6%). The impact on the PPV of smoking (9.7%) and gross haematuria (28.6%) was less dramatic in women. The PPV increased from 16.8% in patients aged <65 years to 23.5% in those aged >65 years. The NPV remained almost always >95% except in men with gross haematuria where it decreased to 77% in smokers and 94% in non-smokers. The PPV of the BladderChek test improves in patients at higher risk of bladder cancer reaching 77% in men presenting with gross haematuria who are aged >65 years and smoke. The NPV is highest in women aged <65 years, up to 100%.

Comparison of NMP22 BladderChek Test and Urine Cytology for the Detection of Recurrent Bladder Cancer

To assess the clinical performance of the NMP22 BladderChek test, which is a qualitative test, and to compare it with voided urine cytology for the detection of recurrent bladder cancer. We also evaluated whether cystoscopy can be omitted from the surveillance protocol by combining the two tests. A total of 131 patients with a history of superficial transitional cell carcinoma of the bladder provided urine samples before a cystoscopic examination. Urine samples were assayed for the presence of NMP22 using the NMP22 BladderChek test and cytology was performed by a cytopathologist. Selected patients underwent a biopsy, with appropriate additional therapy. Results of the two tests were compared with that the results of cystoscopy, which was retained as the gold standard. For positive biopsies, the results of the NMP22 test and cytology were also correlated with the tumor stage and grade. Of the 46 recurrences detected by cystoscopy, the NMP22 test was positive in 39 cases and cytology in 19 cases. The sensitivity of the NMP22 test was 85%, which was significantly greater than that of cytology (41%). In particular, for low-risk tumors it was eight times more sensitive than cytology. The specificities of the NMP22 test and cytology were 77 and 96%, respectively. Combining the two tests increased overall sensitivity to 91%. However, 9% of the tumors were still not detected. The NMP22 BladderChek test is an in vitro qualitative test that is easily available and cheap; it can be performed by a urologist in the office and results can be interpreted within 30 min. The NMP22 test is superior to cytology for all grades and stages in the detection of recurrence in patients with a history of superficial bladder cancer. Our study indicates that the NMP22 test can be used as a substitute for urine cytology. The NMP22 test cannot replace cystoscopy, but it can be used as an adjunct to cystoscopy in the surveillance protocol for patients with superficial bladder cancer.

Urinary NMP22® BladderChek® Test in the Diagnosis of Superficial Bladder Cancer

ObjectiveTo study the diagnostic efficacy of the NMP22® BladderChek® test and to compare it to cytology in the detection of bladder cancer. MethodsWe evaluated 106 voided urinary specimens of patients with suspicion of bladder cancer. All voided urine samples were evaluated by the NMP22 BladderChek test, cytology, sediment and culture. The diagnostic value of the NMP22 BladderChek test was evaluated according to correlation with cystoscopic findings and, in case of tumour, histological findings. A negative test result in a pTaG1 tumour was not considered false-negative in this study. The results were compared to the diagnostic value of cytology. Moreover, the value of the combination of cytology and the NMP22 BladderChek test was determined. ResultsIn total, 29 patients had histologically proven transitional cell carcinoma of the bladder. The NMP22 BladderChek test detected 40% of 15 pTa tumours and 83.3% of the 6 pT1 tumours. Cytology detected pTa in 33.3% and pT1 in 66.6%. The 1 CIS lesion was detected by cytology. In the group of patients in follow-up the sensitivity and specificity were 57.1% (CI 28.8–82.3) and 89.8% (CI 79.2–96.2) for the NMP22 BladderChek test and 42.9% (CI 17.7–71.7) and 93.2% (CI 83.5–98.1) for cytology. ConclusionThe NMP22 BladderChek test has a slightly higher sensitivity compared to cytology, without a relevant loss in specificity. Furthermore it is an easy test with instant result. However, no extra tumours were detected by adjunction of the NMP22 BladderChek test.