BTA试剂在泌尿系移行细胞癌诊断中的应用价值

自１９９６年１１月至１９９７年１１月用膀胱肿瘤抗原（ＢＴＡ）试剂板检测血尿及泌尿系移行细胞癌术后患者尿标本，报告如下。临床资料本组８３例。男６８例，女１５例。年龄２２～８１岁，平均５９６岁。血尿６６例，膀胱肿瘤术后１７例。随机选１０例健康人和１０例...     

两种BTA试剂临床综合应用的研究

应用膀胱肿瘤抗原ｓｔａｔ（ＢＴＡｓｔａｔ）与膀胱肿瘤抗原ｔｅｓｔ（ＢＴＡｔｅｓｔ）两种测试方法对１２０例血尿患者尿样进行检测,探讨其单独及两者联合应用在膀胱肿瘤诊断中的价值。报告如下。材料和方法　１９９７年８月１日～１９９８年４月１日以血尿为首发症状的病人１２０例。年龄２１～８６岁,平均５６岁。男８８例,女３２例。其中膀胱移行上皮细胞癌４２例（３５．０％）;良性前列腺增生症３５例（２９．２％）;输尿管结石６例（５．０％）;输尿管息肉２例（１．６％）;肾盂上皮肿瘤和输尿管上皮肿瘤各１例（０．８％）…     

膀胱肿瘤抗原临床应用效果与评价（附112例报告）

为探讨膀胱肿瘤患者早期诊断的有效方法，对１１２例怀疑或确诊为膀胱肿瘤的患者进行膀胱肿瘤抗原（ＢＴＡ）测定。结果ＢＴＡ诊断膀胱肿瘤的敏感性为７７．４％略低于膀胱镜检查（９６．４％）但明显高于尿脱落细胞学检查（１１．５％）同时ＢＴＡ的阳性率随着肿瘤的分级增加而增高。认为ＢＴＡ测定是膀胱肿瘤早期诊断，预后监测较为灵敏的指标，并具有快速，安全，无创伤的特点，值得在临床上推广应用。     

尿细胞学,BTA,B超联合检查在膀胱癌病人随访中的作用

目的 了解联合应用尿细胞学、尿ＢＴＡ、经腹Ｂ超检查在膀胱癌术后病人随访中的价值。方法 对３１例膀胱癌术后随访病人,先行尿细胞学、尿ＢＴＡ、经腹Ｂ超检查,再行膀胱镜检查。以膀胱镜检查及活检为金标准,分析各种检查的效果。结果 ３１例经膀胱镜检查及活检证实肿瘤复发１４例。尿细胞学、尿ＢＴＡ、经腹Ｂ超检查的灵敏度分别为５０．０％、７８．６％、６４．３％。三种检查联合应用的灵敏度为９２．９％,与膀胱镜检查比     

单抗免疫分析法在血尿及膀胱移行细胞癌诊断中的应用

目的 研究单抗免疫分析法（ＢＴＡ Ｓｔａｔ）在血尿及膀胱肿瘤诊断中的准确性和可靠性。方法 采用ＢＴＡ Ｓｔａｔ检测试剂盒对６５例无痛血尿患者,７１例膀胱移行细胞癌电切术后患者及１０例正常人进行了ＢＴＡ Ｓｔａｔ检测。     

经腹壁超声在膀胱肿瘤诊断与分期中的意义

行经腹Ｂ超检查临床疑诊为膀胱肿瘤患者２９９例，经与膀胱镜检和术后病理结果对照，２７１例证实为膀胱肿瘤，１０例为非膀胱肿瘤，１８例经腹Ｂ超漏诊。本组经腹Ｂ超诊断准确率为９０．６％（２７１／２９９），误诊率为３．３％（１０／２９９），漏诊率为６．０％（１８／２９９）。经腹壁超声判断膀胱肿瘤分期总的正确率为８８．６％（Ｔ_１期肿瘤８９．１％，Ｔ_２期为８６．８％，Ｔ３期为８７．５％，Ｔ_４期为１００．０％）。经腹壁超声方法简单，患者无痛苦，对膀胱肿瘤诊断与分期的准确性较高，应作为膀胱肿瘤的常规检查方法。     

膀胱肿瘤抗原诊断膀胱癌的临床价值

目的：探讨膀胱肿瘤抗原（ＢＴＡ）在诊断膀胱癌中的临床价值。方法：随机选择可疑膀胱癌的血尿患者８９例,应用美国Ｂａｒｄ ＢＴＡ检测盒进行检测。结果：ＢＴＡ诊断膀胱癌的敏感度为６７％,特异度为７８％,准确度为７３％,阳性预测值为７０％,阴性预测值为７５％。结论：ＢＴＡ诊断膀胱癌有简便、快捷、无创伤的优点,可作为膀胱癌筛选和术后监测的指标之一。     

切缘注射加术后灌注预防膀胱肿瘤复发

为降低膀胱癌术后复发率，对２４例患者采用术中切缘注射白细胞介素２（ＩＬ２）和术后膀胱灌注卡介苗（ＢＣＧ）及ＩＬ２治疗。随访６～６６个月，复发率为１２．５％。认为此方法预防膀胱肿瘤术后复发安全有效。     

BTA在膀胱癌诊断中的应用

BTA是一种新的膀胱肿瘤诊断方法,我们从1995年9月至1997年2月间对261例血尿患者及83例膀胱肿瘤术后的患者进行了诊断检测,诊断的敏感度为94.8％,特异度为79.8％,准确度为85.4％,26例膀胱肿瘤患者中仅6例(23％)尿脱落细胞阳性,正常对照均为阴性。认为BTA试剂是一个值得临床推广的诊断膀胱肿瘤的方法。     

膀胱肿瘤抗原检测膀胱癌的临床意义

目的 探讨膀胱肿瘤抗原（ＢＴＡ）对膀胱癌早期诊断的意义。方法 以ＢＴＡ和尿脱落细胞（ＶＵＣ）对３６例膀胱癌进行对比性检测。结果 ＢＴＡ的敏感性为４４．４％，ＶＵＣ为１６．６％，两者有显著性差异（Ｐ〈０．０１）。在早期膀胱癌，ＢＴＡ的敏感性为ＶＵＣ的６倍，进展期是ＶＵＣ的２．５倍。ＢＴＡ的特异性为９０％。结论 ＢＴＡ是一种简便、快速、无创伤性的检测方法，敏感性明显高于ＶＵＣ，尤其是早期膀胱癌中有较高     

Significance of the BTA Test in Bladder Cancer: A Multicenter Trial

Background :
The BTA test is a latex agglutination assay for the qualitative detection in the urine of analytes that are associated with bladder tumor. We compared the results of the BTA test with those of voided urine cytology (VUC) in patients with bladder cancer.
Methods :
A multicenter trial was performed at 6 institutions. A total of 132 patients with histologically diagnosed bladder cancer were enrolled. Urine samples were split for BTA and VUC testing.
Results :
The sensitivities of the BTA test and VUC were 57.6% and 37.9%, respectively; this difference was significant ( P < 0.001). The BTA test had much higher sensitivity for small, solitary, superficial tumors than did VUC.
Conclusion :
The BTA test is simple to perform, gives rapid results, and is far more sensitive than VUC for detection of bladder cancer. The BTA test has the potential to become an additional tool for detecting bladder cancer.     

Evaluation of the BTA tests for the detection of bilharzial related bladder cancer: the Cairo experience

OBJECTIVE: To evaluate the clinical performance of the BTA stat test and the BTA TRAK assay in the diagnosis of bilharzia-related bladder cancer and to calculate a new 'Egyptian' cut-off value for the BTA TRAK (quantitative) assay. METHODS: Urine samples of 149 individuals were tested for the presence of the human complement factor H-related protein, the antigen detected by the BTA stat and BTA TRAK tests. The group consisted of 53 healthy volunteers, 20 patients with active bilharziasis, 11 patients with other urologic disorders including prostate cancer, and 65 patients with histologically proven bladder cancer. All samples were obtained prior to surgery or therapy. RESULTS: The BTA stat test was positive in 64 of 65 samples from patients with bladder cancer, for an overall sensitivity of 99%. With a BTA TRAK assay cut-off of 60 U/ml (set at 97% specificity in the healthy population), the sensitivity of the TRAK assay was 94%. There was no statistically significant difference between the sensitivities of the two BTA tests in patients diagnosed with squamous cell carcinoma and those with transitional cell carcinoma. The overall specificity of the BTA stat test was 67% ranging from 15% in patients with bilharziasis to 94% in healthy volunteers. The overall specificity of the TRAK assay was 66%, again with negative results in 15% of the patients with bilharziasis. CONCLUSIONS: The BTA stat test and TRAK tests are extremely sensitive in the detection of bladder cancer in the Egyptian population. Positive results (85%) are also observed in patients with active bilharziasis, which often leads to bladder cancer. Longitudinal follow-up of these positive cases is needed to determine whether these positive results are false or predictive of bladder cancer.     

COMPARATIVE EVALUATION OF THE DIAGNOSTIC PERFORMANCE OF THE BTA STAT TEST, NMP22 AND URINARY BLADDER CANCER ANTIGEN FOR PRIMARY AND RECURRENT BLADDER TUMORS

PURPOSE: We compared overall sensitivity and specificity of the urinary bladder cancer antigen enzyme-linked immunosorbent assay (UBC, IDL Biotech, Sollentuna, Sweden), BTA stat test (Bion Diagnostic Sciences, Inc., Redmond, Washington) and NMP22 test kit (Matritech, Newton, Massachusetts), and the differential sensitivity regarding the histological pattern of tumors. MATERIALS AND METHODS: A total of 213 patients with clinical and/or imaging signs of bladder cancer provided a single voided urine sample for the bladder cancer antigen, BTA stat test and NMP22 before cystoscopy. Of these patients 95 were monitored for superficial bladder cancer, while the remaining 118 had no history of bladder cancer. All detected bladder tumors or suspicious lesions were resected transurethrally. A group of 21 age and sex matched healthy volunteers were also evaluated with the same tests. RESULTS: Bladder cancer was confirmed histologically in 118 patients, of whom primary and recurrent tumors were in 68 and 50, respectively. The optimal cutoffs calculated with receiver operating characteristics curves were 8 units per ml. for NMP22 and 12 microg./l. for bladder cancer antigen. Overall sensitivity and specificity were 72.9% and 64.6% for the BTA stat test, 63.5% and 75.0% for NMP22, and 80.5% and 80.2%, respectively, for bladder cancer antigen. Bladder cancer antigen proved significantly more sensitive than NMP22 for detecting bladder cancer (p = 0.001) but not more than the BTA stat test, while the specificity of it was significantly higher than that of the BTA stat test (p = 0.009). Bladder cancer antigen had a sensitivity of 80.7% for stage Ta tumors, which was significantly higher than NMP22 (52.6%, p = 0.001) and the BTA stat test (57.9%, p = 0.01). In grade I tumors the sensitivity of bladder cancer antigen (70%) did not differ significantly than that of the BTA stat test (50%) and NMP22 (50%, p = 0.14). Bladder cancer antigen had the least false-positive results in patients with a history of bladder cancer and negative cystoscopy, and those with urological disease other than bladder cancer. CONCLUSIONS: Our data indicate that bladder cancer antigen may be a more potent diagnostic marker for bladder cancer than NMP22 and the BTA stat test based on the higher sensitivity for detecting low stage and low grade tumors, and the higher specificity. The contribution of these tests for detection of bladder cancer should still be considered adjunctive to cystoscopy.     

Comparison of BTA stat and NMP22 tests in the detection of bladder cancer

OBJECTIVE: This study aimed to compare the BTA (bladder tumour antigen) stat and urinary nuclear matrix protein (NMP22) tests in the detection of bladder cancer. MATERIAL AND METHODS: The office-based qualitative BTA stat and the laboratory-based quantitative NMP22 tests were studied in the same urine samples obtained from 49 patients with a high suspicion of bladder cancer and 20 healthy subjects. RESULTS: A tumour was identified in 36 patients after the cystoscopy. BTA stat demonstrated a sensitivity of 89%, which was superior to the sensitivity of 66.6% with the NMP22 test in detecting the bladder cancer (p < 0.02). The sensitivities for grade I tumours with BTA stat and NMP22 were 55.5% and 33.3%, respectively. The sensitivity of BTA stat was 100% for tumour categories except for the pTa and grade I tumours. No positive result was observed with both tests among the healthy subjects. The specificities for BTA stat and NMP22 were 78.7% and 69.6%, respectively. CONCLUSIONS: The BTA stat test was significantly more sensitive than the NMP22 test in the detection of bladder cancer. Although the sensitivity of BTA stat was not sufficient to replace cystoscopy, its ease and low cost may play a role in reducing the number of control cystoscopies, especially in patients with low risk of progression.     

Human complement factor H related protein test for monitoring bladder cancer

PURPOSE: The BTA stat test is a rapid, noninvasive, qualitative urine test that detects bladder tumor associated antigen (human complement factor H related protein) in urine. We compared BTA stat test to voided urine cytology in patients monitored for bladder cancer in a prospective trial, and determined whether this test is effective in detection of recurrence not seen by regular cystoscopy. MATERIALS AND METHODS: A total of 445 consecutive patients with bladder cancer were studied. A voided urine sample was obtained before cystoscopy and divided for culture, cytology and BTA stat testing. In cases of a positive BTA stat test but negative cystoscopy, excretory urography or renal ultrasound, random biopsies and collected ureteral urine samples for ureteral cytology were obtained. The overall sensitivity and specificity as well as positive and negative predictive values for BTA stat test, cytology and their combination were calculated. RESULTS: Of the 445 patients 118 (26.5%) had bladder cancer recurrence on cystoscopy, which was detected by BTA stat test and cytology in 63 (53.4%) and 21 (17.8%), respectively. Of the remaining 327 patients not having recurrent tumor on cystoscopy 81 (24.8%) had a positive BTA stat test. Excretory urography or renal ultrasound and random biopsies in 48 (59.3%) of these patients revealed 7 recurrences, making the total number of recurrent tumors 125 of 412 (30.3%). The overall sensitivities and specificities for the BTA stat test, cytology and their combination were 56.0%, 19.2%, 60.0% and 85.7%, 98.3% and 85.0%, respectively. CONCLUSIONS: The sensitivity for detection of recurrent tumor on BTA stat test is superior to that of voided urine cytology in all bladder cancer categories, whereas the specificity of voided urine cytology is higher than that for BTA stat test. However, a sixth of the patients with apparent false-positive BTA stat test results chosen for further investigation had recurrent tumors that were not found on routine cystoscopy. Although the sensitivity and specificity were highest when both tests were used, the differences were not significant overall. Therefore, the BTA stat test could potentially replace urine cytology for followup of superficial bladder cancer.     

Clinical evaluation of urinary nuclear matrix protein 22 as a marker for bladder cancer]

The purpose of this study is to evaluate the clinical usefulness of urinary nuclear matrix protein 22 (NMP22) as a marker for bladder cancer. We examined the positive rates of NMP22 test, urinary cytology and bladder tumor antigen (BTA) test, and compared the positive rate of NMP22 test with that in urinary cytology and BTA test. Urine samples were obtained from 50 patients with histologically confirmed bladder cancer before the treatment. The samples were examined by NMP22 test, urinary cytology and BTA test. In 50 patients with bladder cancer, the overall positive rate was 40% for NMP22 test, 40% for urinary cytology, and 16% for BTA test. A combination of NMP22 test and urinary cytology showed a significantly higher positive rate (54%) as compared to NMP22 test or urinary cytology alone. When NMP22 test and urinary cytology were compared for tumor size, number, shape, stage and grade, NMP22 test showed a significant higher positive rate than urinary cytology in grade 1 bladder cancer. In conclusion, although NMP22 test and urinary cytology gave a similar positive rate, a combination of NMP22 test and urinary cytology is more useful than the NMP22 test or urinary cytology alone for monitoring of bladder cancer.     

Sensitivity of human complement factor H related protein (BTA stat) test and voided urine cytology in the diagnosis of bladder cancer

PURPOSE: We compared the sensitivity of the BTA statdagger test, a rapid, noninvasive, qualitative urine test that detects bladder tumor associated antigen (human complement factor H related protein) in urine, to that of voided urine cytology in patients with primary bladder cancer. We also assessed the effect of tumor size, number, histological grade and stage on test sensitivity. MATERIALS AND METHODS: We evaluated 151 patients with newly diagnosed bladder cancer in a prospective multicenter study. A voided urine sample obtained before transurethral bladder tumor resection was divided for culture, cytology and BTA stat testing. RESULTS: Overall sensitivity of the BTA stat test and urine cytology for detecting primary bladder cancer was 81.5% and 30.3%, respectively (p <0.0001). The sensitivity of each test increased as tumor size, number, histological grade and stage increased. CONCLUSIONS: Sensitivity of the BTA stat test was superior to that of voided urine cytology in all tumor categories. This noninvasive, easy to perform, point of care test may have the potential to replace cytology for diagnosing bladder cancer.     

Clinical evaluation of urinary basic fetoprotein and the BTA test for detection of bladder cancer

We compared the results of urinary basic fetoprotein (BFP) and the BTA test with those of urinary cytology in patients with bladder cancer. We also analyzed the urinary BFP and the BTA test results in patients with benign diseases and postoperative bladder cancer with no evidence of recurrence. The cutoff value for urinary BFP was set at 10 ng/ml. Classes 4 and 5 according to urinary cytology were defined as positive. The sensitivity of urinary BFP for Ta, 1 bladder cancer was significantly higher than that of urinary cytology (p < 0.05). The urinary cytology positive rate for Ta, 1 bladder cancer improved when combined with urinary BFP and the BTA test. The urinary BFP positive rate for benign diseases was significantly higher in patients with pyuria than in patients without pyuria (p < 0.05). The BTA test positive rate for benign diseases was higher in patients with pyuria than in patients without pyuria. The urinary BFP and the BTA test positive rates for postoperative bladder cancer with no evidence of recurrence was significantly higher in patients with urinary diversion than in patients without urinary diversion (BFP: p < 0.01, BTA: p < 0.05).     

THE BLADDER TUMOR ANTIGEN (BTA) TEST COMPARED TO VOIDED URINE CYTOLOGY IN THE DETECTION OF BLADDER NEOPLASMS

Purpose

Tests to detect recurrent bladder neoplasms are limited and none is consistently accurate. Recent studies suggest that the bladder tumor antigen (BTA*) test, an agglutination reaction for basement membrane complexes, is superior to voided urine cytology in clinical practice. We compared BTA and voided urine cytology to bladder washings and cystoscopy, emphasizing diagnostic yield among patients with causes of basement membrane complexes other than bladder cancer.

Materials and Methods

Random voided urine specimens from 67 patients with a history of bladder neoplasms were collected before cystoscopy and bladder washing. Urine also was obtained from 34 patients with inflammatory bladder conditions including 5 with a history of prostate cancer. Each urine was tested for BTA according to a commericial kit. Positive results were indicated by yellow on a test pad. Blinded to all other results, each urine and each bladder washing were examined microscopically, and a positive test had malignant/suspicious cells. Bladder biopsies were performed when endoscopic lesions were seen. Specimens were grouped into 4 categories: group 1-biopsy proved bladder neoplasm, group 2-history of bladder cancer but not biopsy proved, group 3-history of prostate cancer and group 4-no history of urological cancer.

Results

Voided urine cytology was positive in 54% of specimens from patients with biopsy proved bladder neoplasms compared to 29% for BTA. Relative yield for voided urine cytology versus BTA was not changed if all group 2 cases having a positive bladder washing and positive cystoscopy were assumed to have bladder cancer, nor was relative yield altered by subsequent short-term followup. Of voided urine specimens 14% from group 1 patients and 41% from group 2 patients had scant cells. Overall diagnostic yield was superior for bladder washing. False-positive BTA occurred in 7 of 34 patients with no history of urological or prostate cancer. There were no false-positive voided urine cytology interpretations in these groups.

Conclusions

BTA is not superior to voided urine cytology in detecting bladder neoplasms and may be limited by false-positive reactions in patients with other causes of basement membrane complexes in urine. Voided urine samples may be limited by high frequency of hypocellularity. Of 34 patients with a hypocellular urine specimen 4 had biopsy proved bladder cancer. Bladder washing yields best results but requires instrumentation. No test, including cystoscopy, is accurate always.