Sysmex Europe


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.
More details

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

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

[1] Ecke:
[2] Raitanen:
[3] Garcia-Valendria:


Sysmex Europe GmbH

Bornbarch 1

22848 Norderstedt


+49 (40) 527 26 0

+49 (40) 527 26 100


Product documents

Regulatory Documents

Regulatory documents, such as Instructions for Use, can be accessed with a valid My Sysmex login:

Go to My Sysmex

Explore more

Copyright © Sysmex Europe GmbH. All rights reserved.
Customize your experience

We use cookies to enable you to optimally use our Website and to improve our communication with you. We shall take your selection into account and use only the data for which you give us your consent.

* May lead to restrictions in content and in the user experience
Detail about cookies
Essential cookies
These cookies help to make our website usable by enabling basic features such as page navigation and access to secure areas of our website. Our website cannot function properly without these cookies.
Statistics cookies
By collecting information anonymously, these cookies help us to understand how visitors interact with our website. This information enables us to continually improve our platform.
Marketing cookies
are used to track visitors on websites. The intention is to show advertisements that are relevant and appealing to the individual user and are, therefore, valuable to publishers and third-party advertisers.