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BTAstat for detecting bladder cancer

  • Non-invasive
  • Uses easily accessible sample material: three drops of urine
  • Results are available immediately – in as fast as five minutes
  • Easy-to-handle lateral flow assay; does not require any additional equipment or specific education


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A difficult situation

When testing for bladder cancer – whether as screening or monitoring – there always seems to be an undesirable side to it:

  • The sensitive methods (cystoscopy) are invasive, making patient acceptance difficult.
  • The non-invasive cytology is characterised by high specificity, but low sensitivity, which is hardly acceptable when it comes to serious disease such as cancer.

Screening for bladder cancer among risk groups is important, and for programmes to be successful, patient compliance is necessary.

For those already diagnosed with bladder cancer, the high recurrence rate of up to 85% calls for frequent monitoring.

BTAstat offers a solution

BTAstat is a non-invasive rapid test performed from urine. It is more sensitive than urine cytology and suitable for screening purposes and monitoring support. 

  • Physicians benefit from the higher sensitivity, easy access, low effort and cost-efficiency of the method.
  • Bladder cancer patients will appreciate the convenient, non-invasive procedure from an ordinary urine sample – and experience a relief from their diagnostic burden since this test may allow reducing cystoscopies to the necessary minimum.


Sample material and test procedure

Sample material and test procedure

Requires only three drops of voided urine.
Please note: Samples showing macrohaematuria have to be excluded from the test, as they will not produce a valid result.
1)    Add three drops of urine using the included pipette.
2)    Read the result after five minutes of incubation.

Test principle and specifications

Test principle and specifications

Immunochromatographic test on bladder tumour antigen hCFHrp (BTA) from urine

Sensitivity: 52.5 – 78.0 %


For risk groups such as

  • smokers
  • hair dressers, painters, road constructors, synthetics industry staff, etc. within the scope of occupational health (contact with chemicals contained in paints, tar, solvents)
  • patients with a record of schistosomiasis


Following an approach described in a Spanish study (reference below), the number of cystoscopies in monitoring bladder cancer can be reduced:

Patients suffering from a superficial tumour can be differentiated in patients with high-grade or low-grade tumours, dependent on their probability to recur. Only high-grade patients undergo cystoscopy, while low-grade patients have a BTAstat test performed and, only in case of a positive test, undergo additional cystoscopy.

Seven patients were missed (false-negative test), but all of them belonged to the low-grade group.

Following a monitoring workflow as described above, you can

  • reduce the total number of unnecessary cystoscopies
  • prolong the time interval until the next follow-up with cystoscopy


References / Literature

Sysmex Europe GmbH

+49 (40) 527 26 0
+49 (40) 527 26 100
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22848 Norderstedt

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