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Year : 2000  |  Volume : 16  |  Issue : 2  |  Page : 126-128

Detection of bladder malignancy by bard BTA stat test among patients with haematuria

Department of Urology, Safdarjang Hospital, New Delhi, India

Correspondence Address:
N K Mohanty
D-II/87, West Kidwai Nagar, New Delhi - 110 029
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Source of Support: None, Conflict of Interest: None

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The ideal bladder-tumour-marker should be rapid, of­fice-based, inexpensive, non-invasive, accurate with high sensitivity and specificity.
Aim : Our aim was to compare BTA (Stat) Bard to voided urine for cytology in patients with haematuria in detec­tion of TCC of genito urinary system.
In our study of 120 patients (100 males and 20 females) between the age group of 18 to 85 years presenting with haematuria we investigated with BTA (Stat), urine for cy­tology and cystoscopies as an outpatient procedure.
Result: Result revealed BTA (Stat) to be 87.5% sensi­tive and 71.4% specific in detecting TCC of urinary blad­der and upper tracts while urine cytology showed 25% sensitivity giving a statistically significant p-value (p<0.0001)
Conclusion: We conclude BTA Stat (Bard) to be a sim­ple non-invasive, rapid and highly sensitive test signifi­cantly superior to urine for cytology in detection of TCC of genitourinary system and should be an adjunctive to cystoscopy in surveillance of bladder malignancy but be­cause of its relatively low specificity cannot replace cys­toscopies.

Keywords: BTA Stat; Bard; Bladder Cancer; Surveillance.

How to cite this article:
Mohanty N K, Jha A K, Singh S P, Arora R P. Detection of bladder malignancy by bard BTA stat test among patients with haematuria. Indian J Urol 2000;16:126-8

How to cite this URL:
Mohanty N K, Jha A K, Singh S P, Arora R P. Detection of bladder malignancy by bard BTA stat test among patients with haematuria. Indian J Urol [serial online] 2000 [cited 2023 Mar 28];16:126-8. Available from:

   Introduction Top

Cystoscopy plays the pivotal role in detecting primary or recurrent TCC of urinary bladder but at times Cis and flat type of malignancy in the bladder remain an endo­scopic dilemma requiring multiple biopsies, computer to­mography and other adjunct methods for confirmation. Urine cytology is routinely performed to complement cys­toscopies (Wiener) [1] but its sensitivity and specificity is poor particularly in low grade TCC which accounts for 60-70% of all primary TCC (Raghavan). [2] Again unfortu­nately the results of urinary cytology depend on the train­ing and expertise of the cytopathologist and as in all mor­phological evaluation they have high intra-observer and inter-observer variations (Ooms). [3] Recently simple meth­ods for detecting bladder tumour antigen in the urine have become commercially available (Fradet). [4] The rationale for adjunctive testing is that direct visualisation is not al­ways accurate (Badalament). [5] A positive adjunctive test in the face of a negative visualisation is a signal to inten­sify follow-up and in the future could be a signal to initi­ate non-surgical therapy.

Recent studies have shown that bladder cancer cells express human complement factor H-related protein (hCFHrp) and detection of this protein in urine by BTA Stat qualitative test (Bard) provides useful information in its early detection among patients presenting with haema­turia (Kinder, Sarody & Ellis). [6] Since complement factor H is a normal component of blood, the question consid­ered is whether haematuria necessarily results in a posi­tive urine test for hCFHrp. Studies have shown (Enfield) [7] that the presence of blood in urine specimen does not re­sult in a positive test for hCFHrp by BTA Stat and pres­ence of blood in urine and hCFHrp in urine appear to be independent events.

Bard BTA Stat test is a lateral flow chromatography based rapid immuno assay which measures bladder tu­mour associated antigen in the urine of the individuals diagnosed with bladder cancer. Monoclonal antibodies (Mabs) to the antigen are used to isolate and characterise the assay analyte (Kinder, Rohert & Skarm). [8] BTA Stat being a very easy one-step rapid non-invasive qualitative test for detection of TCC of urinary bladder, if found highly sensitive and specific may replace the more cumbersome and less specific diagnostic tools like urine for cytology and even ultrasonography.

Our aim in this study was to find the specificity and sensitivity of BTA Stat in detection of cancer bladder TCC among patients with haematuria and comparing it with urine for cytology and cystoscopies in diagnosis of TCC of urinary bladder.

   Material and Methods Top

A total number of 120 patients presenting with haema­turia were involved in our study. A voided urine sample was obtained prior to cystoscopy for BTA Stat, urine for cytology and urine analysis. This was followed by cystos­copy. BTA Stat test was performed by placing 5 drops of the voided urine sample collected into the well of the dis­posable test device and awaiting for five minutes to ob­serve the result of the test. Simultaneously urine was sent for cytology. Cystoscopies were performed under local anaesthesia as an outpatient procedure. In situations where BTA Stat was positive but cystoscopy was normal, ran­dom bladder biopsies was taken followed by ultrasonog­raphy of abdomen, IVP or CT Scan.

   Results Top

The average age of our patients was 54 years, ranging from 18 years to 85 years. There were 100 males and 20 females.

BTA Stat was positive in a total number of 72 patients and negative in 48 patients. Out of 72 patients having BTA positive subsequent cystoscopies showed 50 patients (69.46%) having TCC of urinary bladder, 4 patients (5.56%) had ureteric malignancy proved on IVP and 2 patients (2.77%) had 'FCC of renal pelvis, while 3 patients (4.16%) had RCC of kidney, 2 patients (2.77%) had TCC of renal pelvis, 3 patients (4.16%) had RCC of kidney, 2 patients (2.77%) had GUTB and 3 patients (4.16%) had polypoid cystitis on biopsies while 8 patients (11.12%) showed no definite cause for their haematuria excepting UTI. From the above result, a total positive for TCC ma­lignancy was seen in 56 patients (50+4+2), i.e., 77.79% (True positive) and 16 patients, i.e., 22.21 % (False posi­tive). Out of the 48 patients showing BTA negative, 40 patients were diagnosed to be having haematuria due to BPH and 8 patients were known cases of malignancy of urinary bladder with tumour recurrence [Table 1].

Out of 56 patients with TCC malignancy of GUS. cy­tology was positive in only 14 patients (25%) and this when compared with BTA Stat (77.83%), shows BTA to be more sensitive than cytology in all categories of stage & grade of the disease [Table 2], a statistical significance was observed (p<0.001).

   Discussion Top

BTA Stat is superior to cytology in the early detection of TCC of genitourinary system. The highly sensitive BTA Stat makes it a useful tool to use in conjunction with stand­ard cystoscopies (H. Leyh 1997), [9] for surveillance of pa­tients with haematuria for early detection of TCC of genito­urinary system but its low specificity requires this test not to be used without ruling out potential interferences such as RCC, polypoid cystitis, GUTS & UTI.

An advantage of BTA Stat over CPE is that TCC of the upper tract, i.e., renal pelvis and ureter are not detected by CPE but a positive BTA Stat in such patients with haema­turia makes one to investigate further with IVP & CT scan. Our results show BTA to be 87.5% sensitive and 71.4% specific in diagnosis of TCC of urinary bladder and the upper tract of the genito-urinary system and is much su­perior to urine for cytology. Our result is comparable to that shown by Mika P, [10] Ley H [11] and Michael F. Sarosdy. [12] This is a very sensitive adjunctive diagnostic tool in early detection of TCC of urinary bladder but cannot replace cystoscopies.

   Conclusions Top

BTA Stat is a simple, non-invasive highly sensitive test and is significantly superior to urine for cytology analysis as an adjunctive test to cystoscopy, in surveillance/early detection of TCC of urinary bladder.

   References Top

1.Wiener HG, Vooija GP et al. Accuracy of urinary cytology in the diagnosis of primary and recurrent bladder cancer. Acta Cytol 1993; 37: 163.  Back to cited text no. 1    
2.Raghavan D, Shipley WU et al. Biology and management of bladder cancer. N Engl J Med 1990; 322: 1129.  Back to cited text no. 2    
3.Ooms ECM, Kurver P et al. Morphometric grading of bladder tumours in comparison with histologic grading by pathologist. Hum Path 1983; 144: 140.  Back to cited text no. 3    
4.Fradet Y, Cordon Cardo C. Critical appraisal of tumour markers in bladder cancer. Semin Urol 1993; 11: 145.  Back to cited text no. 4    
5.Badalament RA. Hermansen DK et al. The sensitivity of bladder wash flow cytometry. Bladder wash cytology and voided cytology in the detection of bladder carcinoma. Cancer 1987; 60: 1423.  Back to cited text no. 5    
6.Kinder RJ et al. Detection of CFHrp in urine BTA Stat qualitative test. Proc Amer Assoc Cancer Res 1997; 38: 29.  Back to cited text no. 6    
7.Enfield DL, Ishak LM. Haematuria and complement factor H-related protein levels in urine appear to be independent. J Urol (Suppl) 1998;159:5.  Back to cited text no. 7    
8.Kinder, Robert et al. The bladder tumour associated antigen measured by the BTA Stag"' test is expressed by bladder tumour cells. Eur Urol (Suppl 1) 1998: 33.  Back to cited text no. 8    
9.Ley H, Marberger M et al. Results of an European Multicenter Trial comparing the BTA StatTM test to urine cytology in patients suspected of having bladder cancer. J Urol (Suppl 4) 1997; 159.  Back to cited text no. 9    
10.Mika PR, Timo Martillila et al. The Bard BTA StatTM test in monitoring of bladder cancer. J Urol (Suppl 5) 1998: 159.  Back to cited text no. 10    
11.Ley H, Treiba U, Marberger M. European Multicenter Trial comparing the BTA StatTM to urine cytology in patients suspected of having bladder cancer. Eur Urol (Suppl 1) 1998; 33.  Back to cited text no. 11    
12.Sarosdy ME, Hudson MA, Ellis WJ et al. Improved detection of recurrent bladder cancer using the Bard BTA Stat test. Urology 1997: 50: 349-353.  Back to cited text no. 12    


  [Table 1], [Table 2]


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