Bladder Tumor Antigen Test Research Articles

Isomorphic red blood cells using automated urine flow cytometry is a reliable method in diagnosis of bladder cancer

We aimed to identify patients with a chief complaint of hematuria who could safely avoid unnecessary radiation and instrumentation in the diagnosis of bladder cancer (BC), using automated urine flow cytometry to detect isomorphic red blood cells (RBCs) in urine. We acquired urine samples from 134 patients over the age of 35 years with a chief complaint of hematuria and a positive urine occult blood test or microhematuria. The data were analyzed using the UF-1000i (®) (Sysmex Co., Ltd., Kobe, Japan) automated urine flow cytometer to determine RBC morphology, which was classified as isomorphic or dysmorphic. The patients were divided into two groups (BC versus non-BC) for statistical analysis. Multivariate logistic regression analysis was used to determine the predictive value of flow cytometry versus urine cytology, the bladder tumor antigen test, occult blood in urine test, and microhematuria test. BC was confirmed in 26 of 134 patients (19.4 %). The area under the curve for RBC count using the automated urine flow cytometer was 0.94, representing the highest reference value obtained in this study. Isomorphic RBCs were detected in all patients in the BC group. On multivariate logistic regression analysis, only isomorphic RBC morphology was significantly predictive for BC (p < 0.001). Analytical parameters such as sensitivity, specificity, positive predictive value, and negative predictive value of isomorphic RBCs in urine were 100.0, 91.7, 74.3, and 100.0 %, respectively. Detection of urinary isomorphic RBCs using automated urine flow cytometry is a reliable method in the diagnosis of BC with hematuria.

Urinary BTA: indicator of bladder cancer or of hematuria

In this study, we investigated the influence of hematuria on the performance of the bladder tumor antigen (BTA) tests in a clinical cohort and in an experimental model. Urine samples from a cohort of 126 subjects (64 with BCa and 62 controls) were analyzed by ELISA for hemoglobin and BTA. The experimental model involved the spiking of urine with blood from the same subject, and hemoglobin, red blood cell count, and BTA levels (BTA stat© and BTA-TRAK©). BTA-TRAK© analyses were also performed on serum samples obtained from 40 subjects (20 with confirmed with BCa). In the 126 subject cohort, correlation between hemoglobin and BTA was 0.732. Of the 64 BCa samples, 72 % had a positive BTA assay, but 47 % of controls were also positive. The sensitivity and specificity of BTA to detect BCa was 72 and 53 %, respectively. Hematuria, measured by urinary hemoglobin, was a better indicator of BCa with 75 % sensitivity and 90 % specificity. Spiking of BTA-negative urine samples with as little as 1 μl/10 ml was enough to produce a positive BTA test. High levels of BTA were found equally in the serum of subjects with or without BCa (mean BTA levels 355,159 vs. 332,329 U/ml, respectively). Rather than detecting a bladder tumor antigen, urinary BTA assays may be measuring serum cFH introduced by bleeding, a common presenting factor in BCa subjects. The presence of hematuria in subjects without malignant disease can result in false-positive BTA assays.

Quantitative measurement of telomerase reverse transcriptase mRNA and chromosomal analysis of urine by M-FISH in the diagnosis and follow-up of bladder cancer

This study was performed to evaluate the clinical utility of the measurement of the expression of telomerase enzyme (the catalytic subunit of the complex hTERT) and of the chromosomal analysis of urine by multicolor fluorescence in situ hybridization (M-FISH) assay for the detection of bladder cancer and its recurrence. These results were compared with those afforded by urine cytology, hematuria screening and the bladder tumor antigen (BTA) and fibrin degradation products (FDP) tests. Urine samples were obtained from three groups: 30 patients with bladder cancer, 15 patients with non-malignant bladder disorders and 8 healthy individuals. hTERT mRNA was measured by reverse transcription real-time PCR. M-FISH was performed using a mixture of fluorescent labeled probes for the centromeric regions of chromosomes 3, 7, 17, and the locus specific identifier p16 probe for the 9p21 locus. We demonstrated that the overall sensitivity of hemoglobin dipstick and the BTA and FDP tests was insignificantly greater than that of urine cytology, but with a lower specificity. The hTERT mRNA expression marker offered significantly greater sensitivity for detecting all bladder cancers, especially superficial and low grade tumors, than did urine cytology, and with a higher specificity. M-FISH was significantly more sensitive than urine cytology in detecting bladder tumors, but had lower specificity (insignificant results). The superior sensitivity of M-FISH was maintained when comparing the two assays in terms of low-stage and low grade tumor detection. M-FISH was the most sensitive and specific test in detecting tumor recurrence, followed by the BTA test. hTERT, hematuria screening and FDP showed relatively low sensitivity and low specificity during follow-up. Our findings suggest that the assessment of hTERT expression and chromosomal abnormalities in urine represent reliable tools - equally specific yet far more sensitive than conventional cytology - for the early detection of bladder cancer. The high sensitivity of FISH in detecting recurrence makes it useful for reducing the number of cyctoscopies usually performed in the accurate follow-up of these cases.

Noninvasive detection and prediction of bladder cancer by fluorescence in situ hybridization analysis of exfoliated urothelial cells in voided urine

Objectives. To investigate the clinical utility of fluorescence in situ hybridization (FISH) of voided urine in the detection of bladder cancer and the prediction of its recurrence. Methods. FISH with centromere-specific probes for chromosomes 9 and 17 was performed to evaluate the chromosomal alterations of exfoliated urothelial cells in voided urine obtained from 44 patients with bladder cancer and 20 controls. The analysis was also performed in 17 patients with bladder cancer after complete transurethral resection to prospectively determine whether FISH can predict tumor recurrence. Results. The sensitivity to detect bladder cancer by FISH analysis (85%) was significantly higher than that by urine cytologic examination (32%) and by the bladder tumor antigen test (64%) ( P <0.0001 and P = 0.026, respectively). The specificity of FISH, cytologic analysis, and the bladder tumor antigen test was 95%, 100%, and 80%, respectively. Among the 17 patients tested after transurethral resection, 7 of 13 FISH-positive patients developed tumor recurrence within the 27-month follow-up period; none of 4 FISH-negative patients developed recurrence during the same period. The recurrence rate in patients with the loss of chromosome 17 was 100%, significantly higher than the 23% for patients without this alteration ( P = 0.015). Conclusions. These findings suggest that FISH analysis of exfoliated urothelial cells in voided urine can efficiently detect bladder cancer and predict its recurrence.

Comparison of two qualitative assays, the UBC rapid test and the BTA stat test, in the diagnosis of urothelial cell carcinoma of the bladder

Objectives. To compare the diagnostic value of two rapid tests, the bladder tumor antigen (BTA stat) test and the newly developed urinary bladder cancer (UBC) Rapid test, in patients having symptoms suggestive of urothelial cell carcinoma (UCC) and patients being followed up after transurethral resection. Methods. One hundred eighty patients with a mean age of 65.8 years (range 22 to 92) were included in the present study. The tests were performed on voided urine samples. Fifty-seven patients had symptoms suggestive of UCC and 123 patients were being followed up after complete transurethral resection of UCC. The voided urine was evaluated by the BTA stat and UBC Rapid test, which detects cytokeratins 8 and 18. All patients underwent subsequent cystoscopic evaluation and biopsy of any suspicious lesion. Results. In 53 patients with histologically proved UCC, the BTA stat had a sensitivity of 52.8% and the UBC Rapid test of 66%. According to the histologic stage, the sensitivity of the BTA stat was 42.8% in pTa tumors, 61.5% in pT1, and 70% in pT2 or higher tumors. The sensitivity of the UBC test was 60.7% in pTa, 69.2% in pT1, and 80% in pT2 or higher tumors. For histologic grades 1 to 3, the sensitivity was 38.8%, 52.6%, and 68.7% for the BTA stat and 44.4%, 78.9%, and 75% for the UBC Rapid test, respectively. The specificity was 70% and 90% for the BTA stat and UBC Rapid test, respectively. Conclusions. The UBC Rapid test was superior to the BTA stat in both sensitivity and specificity. Both assays are simple office procedures and require no special knowledge. However, they cannot replace, but only lower, the number of cystoscopies during the follow-up of patients with previous UCC of the bladder.

Evaluation of Urinary Level of NMP22 as a Diagnostic Marker for Stage pTa-pT1 Bladder Cancer: Comparison with Urinary Cytology and BTA Test

Background: In the present study we compared the clinical value of two new specific tests for transitional cell carcinoma, urinary nuclear matrix protein (NMP22) levels and bladder tumor antigen (BTA) test, with that of urinary cytology in the follow-up of patients with superficial bladder cancer. Materials and Methods: Hundred and five bladder cancer patients were recruited: 30 stage pTa and 45 stage pT1 (group A), and 30 with a history of bladder cancer but no recurrence at the time of the study (group B). Urine samples were collected before any instrumental manipulation of the genitourinary tract. All patients were negative for urinary tract infections at conventional urine analysis. Results: NMP22 at a cutoff value of 6 U/ml showed a sensitivity of 83.3% in pTa cases and 97.7% in pT1 cases, with a false-positive rate of 23.3%. The BTA test was positive in 26.6% of patients with cancer stage pTa and in 66.6% of pT1 stage, with 30% false-positives in the non-neoplastic group. Urinary cytology, performed on three consecutive samples, was positive in 20% of patients with cancer stage pTa and in 64.4% of pT1 stage and did not show any false-positive cases. Stratifying the neoplastic patients according to lesion grade, NMP22 (at a cutoff value of 6 U/ml) was positive in 86.2% of G1, 97.2% of G2 and 90% of G3. BTA was positive in 37.9, 52.7 and 70% of G1, G2 and G3, respectively, while urinary cytology was positive in 37.9, 44.4 and 80%.

Comparison of fluorescence in-situ hybridization (fish) and bladder tumor antigen test (BTA®) in bladder cancer: A pilot study

Comparison of fluorescence in-situ hybridization (fish) and bladder tumor antigen test (BTA®) in bladder cancer: A pilot study

Initial Evaluation of the Bladder Tumor Antigen Test in Superficial Bladder Cancer

Initial Evaluation of the Bladder Tumor Antigen Test in Superficial Bladder Cancer

Initial Evaluation of the Bladder Tumor Antigen Test in Superficial Bladder Cancer

Purpose We analyzed the value of the Bard bladder tumor antigen (BTA * * Bard Urological, Covington, Georgia. ) test for the diagnosis of stage Ta superficial bladder cancer and carcinoma in situ, and compared it to the highly sensitive bladder washing cytology. Materials and Methods The BTA test is a latex agglutination test that qualitatively detects the presence of basement membrane complexes in the urine. A total of 60 patients with superficial bladder cancer underwent voided urine BTA analysis and bladder washing cytologies. Results Of the patients 65 percent were correctly diagnosed with the BTA test compared to 32 percent with bladder washings, which is statistically significant (p less than 0.001). Conclusions The BTA test is a noninvasive diagnostic tool that is superior to bladder washing cytology for diagnosing superficial bladder cancer.

Results of a Multicenter Trial using the BTA Test to Monitor for and Diagnose Recurrent Bladder Cancer

Objectives We compare the Bard BTA † † Bainbridge Diagnotic Sciences, C.R. Bard, Inc., Redmond, WA. (bladder tumor antigen) test to voided cytology studies in patients undergoing surveillance cystoscopy for recurrent bladder cancer. Materials and Methods A prospective, blinded, multicenter trial was performed. Results A total of 499 patients underwent 1,014 cystoscopic examinations and tumor was identified in 151. The bladder tumor antigen test was mode sensitive than cytology studies in detecting recurrent cancer (p less than 0.001), being positive in 61 cases versus 25 for cytology. The trial in healthy volunteers and nonurological patients estimates bladder tumor antigen test specificity to be 95.9 percent. Conclusions The bladder tumor antigen test is a simple, rapid and inexpensive adjunct to cystoscopy, and the results are equivalent or superior to those of voided cytology as performed in this trial.