Clinical significance of combined detection with urinary nuclear matrix protein 22 and cytokeratin 20 mRNA in the monitoring of bladder tumor recurrence / 重庆医学

Objective To detect the expression of urinary nuclear matrix protein 22(NMP22) and cytokeratin 20(CK20) mRNA in the monitoring of bladder tumor recurrence ,and to explore the clinical value of combined detection of urinary NMP22 and CK20 mRNA in the monitoring of bladder tumor recurrence .Methods Enzyme‐linked immunosorbent assay(ELISA) and nested reverse transcriptase polymerase chain reaction(Nested RT‐PCR) were used to detect the expression of NMP22 and CK20 mRNA in the u‐rine of 46 patients with recurrent bladder cancer tumor (recurrent group) ,66 patients without recurrent tumor (no‐recurrent group) and 40 healthy volunteers(control group) respectively .Results The expression of NMP22 and CK20 mRNA in the urine of control group were negative .There was statistically significant difference between the positive expression rate of NMP 22 and CK20 mRNA in the urines of the recurrent group[78 .3% (36/46) ,80 .4% (37/46))] and that of the no‐recurrent group[6 .1% (4/62) , 6 .1% (4/62)] and the control group respectively (P0 .05) .The expression level of NMP22 in recurrent tumor increased obviously along with the progression of the pathological grade and clinical classification of tumor (P0 .05) .Conclusion The positive expression of CK20 mRNA may also indicate tumor multiplicity .Combined detection of NM P22 and CK20 mRNA significantly increases the sensitivity and specificity in clinical detection .

Evaluation of Urine NMP22 Point-of-Care Test for the Screening of Bladder Cancer / 대한진단검사의학회지

BACKGROUND: Screening of high-risk patients using bladder tumor markers can offer an advantage of early detection and saving medical costs. For these purpose many tumor markers have been developed to supplement invasive cystoscopy. Our study evaluated the NMP22 point-of-care test (NMP22 POCT), which is one of the tumor makers, comparing with the standard urine cytology for the diagnosis of bladder cancer. METHODS: From January to September 2005, 232 patients who had undergone a cystoscopy due to bladder cancer associated symptoms including hematuria and dysuria were enrolled in this study. Urine specimens were collected for NMP22 POCT and cytology. NMP22 POCT and urine cytology were compared for sensitivity and specificity. In addition, we evaluated urine stick test and microscopy to explain some false-positive results in NMP22 POCT. RESULTS: Superficial transitional cell carcinoma was diagnosed in 10 patients. The sensitivity of NMP22 test was 60% (95% confidence interval [CI], 26.2-87.8%), whereas that of cytology was 33.3% (95% CI, 7.5-70.1%); however, the difference was not significant. The specificity of NMP22 test was 69.8% (95% CI, 63.3-75.8%), compared with 99.0% (95% CI, 96.5-99.9%) for cytology (P<0.001). The presence of microscopic RBCs in urine specimen was significantly associated with the lower specificity of NMP22 POCT (P=0.02). CONCLUSIONS: NMP22 POCT was significantly less specific than urine cytology. To be useful as a bladder cancer screening test, the NMP22 test should have a higher specificity.

Usefulness of NMP22 BladderChek for the Diagnosis and Monitoring of Bladder Cancer / 대한진단검사의학회지

BACKGROUND: As bladder cancer is a superficial tumor with frequent recurrences, early detection and confirmation of recurrence are important. We evaluated the usefulness of NMP22 BladderChek (NMP22BC) for the diagnosis and monitoring of bladder cancer. METHODS: From July to December 2004, we enrolled in the study 670 patients who visited the urology clinic in Ewha Womans University, Dongdaemun Hospital with hematuria or dysuria and were tested with NMP22BC. We also performed the NMP22BC and BTA stat tests simultaneously in 21 patients and interference test in 10 patients. RESULTS: NMP22BC tests were negative in 97% of the patients who had been cured of bladder cancer and were positive in 95% of the patients with recurred bladder cancer. The diagnostic sensitivity, specificity, positive and negative predictive value, and efficiency were 95.0%, 91.5%, 25.7%, 99.8%, and 91.6%, respectively, with 8.5% false positive and 5% false negative rates. Fifty-five patients showed false positive in the NMP22BC test, the main cause of which was the presence of WBCs in urine. There was a good agreement between the NMP22BC and BTA stat tests (kappa agreement value, 0.5; P=0.008). According to the interference test, two patients with more than 3+ in leukocyte esterase results showed false positive in the NMP22BC test. CONCLUSIONS: NMP22BC test was simple to perform, rapid to produce the results, and useful in diagnosing a bladder cancer recurrence; the test shows a high efficiency with a high sensitivity, specificity, negative predictive value, and low false negative rate.

Clinical significance of NMP 22 in early diagnosis of bladder cancer / 中华泌尿外科杂志

10 U/ml was determined as positive value.Urinary NMP 22 protein was elevated in 22 cases.Bladder cancer was diagnosed in 11 cases.The sensitivity and specificity of the NMP 22 test were 100%(11/11) and 81%(46/57),respectively.Cystoscopy alone identified 35% of the cancers (4/11).Among 22 cases with elevated NMP 22,1 case was dignosized as bladder cancer during 1 year visit. Conclusions Urine NMP 22 is a new useful marker in early diagnosis of bladder cancer.

Evaluation of the Usefulness of Immediate-Cytospin Wright-Stained Urine Cytology in the Screening and Monitoring of Bladder Cancer / 대한진단검사의학회지

BACKGROUND: The goal of this study is to assess the usefulness of immediate-cytospin Wright stain cytology with bladder tumor markers such as BTA and NMP22 in the screening and monitoring of bladder cancer. METHODS: We evaluated immediate-cytospin (cytospin 3, Shandon, UK) Wright stain and Papanicolau stain urinary cytology with the BTA stat (Bion Diagnostic Sciences, Inc., Redmond, WA, USA) and the NMP22 (Matritech, Newton, MA, USA) in 143 urine specimens for screening and monitoring of bladder cancer from September 2001 to May 2002. The cut-off decision level of NMP22 was determined by the receiver-operating characteristics (ROC) curve and those above the cut-off were classified as positive. The Wright and PAP stained urinary cytology results were reviewed by two experts. Negative and atypia cytology results were classified as negative, and suspicions of malignancy and malignancy results were classified as positive. RESULTS: The ROC curve analysis for NMP22 demonstrated optimal sensitivity and specificity (81.8% and 83.8%, respectively) with the cut-off decision level 11.0 IU/mL. Sensitivity, specificity, false positive rate, and false negative rate for the BTA stat were 62.5%, 92.9%, 47.4%, and 4.8%, respectively, and 81.8%, 83.8%, 55.0%, and 3.4%, respectively for the NMP22. Whereas, those values for immediate-cytospin Wright stain cytology were 90.9%, 98.4%, 16.7%, and 0.8%, respectively, showing a 100% concordance rate with Papanicolau stained cytology. The area under the ROC curve of the BTA stat, the NMP, and the immediate-cytospin Wright stain cytology was 0.78, 0.81, and 0.95, respectively. CONCLUSIONS: Immediate-cytospin Wright stain cytology was useful for the decrease in false positivity and false negativity for tumor markers such as the BTA stat and the NMP22 in screening and monitoring for bladder cancer.

The Clinical Utility of BTA TRAK, BTA stat, NMP22 and Urine Cytology in the Diagnosis of Bladder Cancer: A Comparative Study / 대한비뇨기과학회지

PURPOSE: Various tumor markers, developed recently for the diagnosis of bladder cancer, are reported to be superior to urine cytology in terms of their sensitivity and non-invasiveness. A prospective study was performed to evaluate the efficacies of BTA TRAK, BTA stat, NMP22 tests and urine cytology. MATERIALS AND METHODS: Between August 2001 and December 2001, 154 patients were involved in the study. Voided urine was used to perform BTA TRAK, BTA stat, NMP22 tests and cytology. The final diagnoses were pathologically proven transitional cell carcinoma (TCCa) of the bladder in 34 patients, gross or microscopic hematuria without detectable tumor in 27, history of TCCa without evidence of recurrence in 68 and benign urologic diseases in 25. RESULTS: The sensitivities of the BTA TRAK, BTA stat, NMP22 and urine cytology were 82.4, 79.4, 61.8 and 32.4%, respectively. The specificities were 75.8, 70.8, 95.8 and 92.5%, respectively. When the sensitivity was subdivided according to the tumor stage, grade and size, the bigger size yielded higher sensitivities in the NMP22 and BTA TRAK (p<0.01 and p=0.03, respectively). When the results of the urine cytology were combined with each of the other tests, the specificity was lower than each test alone for the BTA TRAK and BTA stat, while sensitivity and specificity were both higher than each test alone for the NMP22. CONCLUSIONS: The BTA TRAK, BTA stat and NMP22 tests are useful in overcoming the limitations of cystoscopy and cytology as the initial evaluation tools for patients where bladder cancer is suspected. In particular, the NMP22 may be more useful due to its enhanced specificity when combined with the urine cytology.

Evaluation of the NMP22 test and comparison with voided urine cytology in the detection of bladder cancer

The purpose of this study was to assess the clinical performance of the NMP22 test and to compare it with that of voided urine cytology for the detection of bladder cancer. The NMP22 test was evaluated in two groups of patients. The first group was comprised of patients with histologically confirmed active transitional cell carcinoma (TCC) of the bladder, and the second group contained those with a history of bladder TCC but that were considered to have no evidence of disease on the basis of cystoscopic evaluation of bladder and/or biopsy. Sensitivity was determined in voided urine samples from patients with active TCC of the bladder. Specificity was determined in the urine samples of patients with a history of bladder TCC but no current evidence of disease. The NMP22 test was positive in 53 of 70 samples from patients with active bladder TCC. The sensitivity of the NMP22 test (75.7%) is significantly better than that of voided urine cytology (55.7%). The specificity of the NMP22 test and of voided urine cytology were 72.2% and 88.9% respectively, in patients with a history of bladder TCC but no current evidence of disease. There was no significant difference between the specificity of NMP22 and that of urine cytology. The NMP22 test is superior to voided urine cytology in the detection of TCC of the bladder. The results of this study indicate that the NMP22 test is an useful adjunct to cystoscopy in the detection and monitoring of TCC of the bladder.

Urinary NMP(nuclear matrix protein)22 in Screening and Post-treatment Follow-up of Bladder Cancer / 대한비뇨기과학회지

PURPOSE: Successful treatment of bladder cancer greatly depend upon the regular surveillance for early detection of persistent or recurrent cancer. We assessed the efficacy of urinary NMP22 test in screening and post-trearment follow-up for bladder cancer. MATERIALS AND METHODS: Urinary NMP22 test kit, which is based on an enzyme-linked immunosorbent assays, were used to measure the values of urinary NMP22 in 30 patients of transitional cell carcinoma of the bladder, 32 healthy volunteers, 12 patients of urinary tract infection and 13 patients of other urinary malignancy. RESULTS: Median values of urinary NMP22 in patients with bladder cancer were significantly greater than in healthy volunteers(p<0.05). With a cutoff value of 15units/ml, urinary NMP22 test had a 90.0% of sensitivity and a 90.6% of specificity in predicting bladder cancer. There was significant postoperative decrease of urinary NMP22 values in all patients with bladder cancer(p<0.05). CONCLUSIONS: These results suggest that urinary NMP22 test is useful for screening and postoperative surveillance of patients with transitional cell carcinoma of urinary bladder. Further comparative studies of urinary NMP22 test with the results of postoperative cystoscopy or cold cup biopsies are requested to enhance the practical utility of urinary NMP22 test.

The Significance of Urinary Nuclear Matrix Protein ( NMP22 ) Measurement in Patients with transitional Cell Carcinoma of the Bladder / 대한암학회지

PURPOSE: The objective of this study was to evaluate an immunoassay for urinary nuclear matrix protein (NMP22) as an indicator for transitional cell carcinoma of the bladder. MATERIALS AND METHODS: Three groups of subjects attended the trial of NMP22. First group was 27 patients with transitional cell carcinoma of the bladder, second group was 24 patients with other urinary cancer consisted of prostate cancer and renal cell carcinoma, and third group was 24 healthy volunteers. NMP22 was determined using a commercial test kit, which is based on an enzyme-linked immunosorbent assay. RESULTS: In normal healthy volunteers and other urinary cancer group median NMP22 levels were 2.24 and 3.27 U/ml, respectively. Median urinary NMP22 levels in patients with transitional cell carcinoma of the bladder were 54.30 U/ml. It was significantly greater than other two groups. Median NMP22 levels according to the tumor stage and the tumor grade did not show the significant difference statistically. CONCLUSIONS: Urinary NMP22 is a useful marker that is more specific for bladder cancer thsn for other urinary cancer. Further tests are required to clarify the influence of other spe- cific conditions, such as urinary tract infection, and intravesical drug instillation or procedure.

Evaluation of urinary NMP_(22) in the detection of transitional cell carcinoma of bladder / 中国癌症杂志

0. 05) . The sensitivity and specificity of NMP-,2 in diagnosing transitional cell carcinoma of bladder were 85. 7% and 60% when the cut-off was set 10 u/ml, In contrast, the sensitivity and specificity of urinec cytology were 32. 1% and 100%. Conclusions: Urinary NMP22 can be used to screen and follow up transitional cell carcinomas of bladder with high sensitivity and high specificity.

Urinary Nuclear Matrix Protein ( NMP 22 ) in the Detection of Transitional Cell Carcinoma of the Bladder / 대한암학회지

PURPOSE: The detection of bladder cancers by noninvasive techniques remains an unsolved problem. We evaluate the availability of an immunoassay for urinary nuclear matrix protein, NMP 22, as an indicator for transitional cell carcinoma of the bladder. MATERIALS AND METHODS: Three groups of subjects participated in this trial of NMP 22: 22 patients with transitional cell carcinoma (group 1), 12 patients with urinary tract infection (group 2) and 31 healthy volunteers (group 3). NMP 22 was determined by ELISA using a commercial test kit (NMP 22 Test Kit, Matritech Inc., USA), We compared urinary NMP 22 levels to the grade, stage, cytology and DNA flowcytometry of transitional cell carcinoma of bladder. RESULTS: NMP 22 values in these 3 groups were significantly different (group 1, median 24.81 U/mL; group 2, median 8.41 U/mL; and group 3, median 5.12 U/mL; Mann-Whitney U test for differences between 3 medians, p < 0.05). The patients with transitional cell carcinoma had significantly greater urinary NMP 22 levels than those with no evidence of tumor (Mann-Whitney U test for differences between 2 medians, p<0.01). There was no zelationship between the urinary NMP 22 levels and tumor grade, stage, cytology or DNA flowcytometry. CONCLUSIONS: It is possible that urinary NMP 22 could improve the detection of bladder transitional cell carcinoma.

Significance of Urinary NMP22 in Patients with Bladder Tumor as a Diagnostic Test / 대한비뇨기과학회지

PURPOSE: The objective of this study was to evaluate the significance of urinary Nuclear Matrix Protein22(NMP22) in patients wish bladder tumor as a diagnostic test MATERIALS AND METHODS: A total persons were divided into three groups. First group were 26 patients with bladder tumor, second group were 31 persons of normal control, third group were 28 patients with UTI(urinary tract infection). NMP22 was assayed using a commercial test kit. RESULTS: Mean NMP22 in bladder tumor group(50.6units/ml) was significantly higher than mean NMP22 in normal control group(8.4units/ml). But, mean NMP22 in bladder tumor group was not significantly higher than mean NMP22 in UTI group(47.3units/ml). Mean NMP22 did not correlate with tumor stage or tumor grade in patients with bladder tumor(p> 0.05). Sensitivity, specificity, positive and negative predictive value of NMP22 in bladder tumor(cut-of value: 10units/ml) were 73.1%(19/26), 67.7%(21/31), 65.5%(19/29) and 75%(21/28), respectively. Sensitivity of urine cytology were 50%(13/26) in the bladder tumor groups. CONCLUSIONS: Our data suggest that NMP22 in patient with bladder tumor could be a good diagnostic test. High NMP22 level in patients with UTI, however, might be decrease the availability of MMP22 in diagnosis of bladder tumor.

CLINICAL EVALUATION OF URINARY LEVEL OF NUCLEAR MATRIX PROTEIN 22(NMP22)IN DIAGNOSIS OF UROTHELIAL CANCER / 解放军医学杂志

To evaluate the clinical value of NMP22 for the diagnosis of urothelial cancer. Urinary NMP22 was determined with enzyme linked immunoaorbent assay (ELISA) in 50 patients in whom 24 patients were suffering from cancer of urothelium, and 20 cases of cancer of other origins, and 6 cases of artificial bladder after total cystectomy for cancer. The median NMP22 value of urothelial cancer was 37 49U/ml, which was significantly higher than those of other patients (4 33U/ml, P