- Design
- Prospective multicentre observational diagnostic accuracy study
- Population
- 691 adults with visible or non-visible haematuria referred for cystoscopy, Australia
- Primary outcome
- Diagnostic performance against cystoscopy and histology
- Effect
- Sensitivity 89%, specificity 79%, PPV 27%, NPV 99%; 6 tumours missed
AUSSIE was a prospective, multicentre observational study at four Australian sites evaluating Cxbladder Triage Plus, a commercial urinary biomarker assay, in 691 adults with visible or non-visible haematuria referred for cystoscopy. The test was run on a urine sample before cystoscopy, which with histology was the reference standard.
Urothelial or other bladder tumours were found in 54 (7.8%). The test had a sensitivity of 89%, specificity of 79%, positive predictive value of 27% and negative predictive value of 99%; 74% of patients tested negative. Six tumours were missed: five low-grade Ta tumours and one urachal adenocarcinoma. Against American Urological Association risk criteria, it raised the positive predictive value about 3.3-fold.
A test that clears three-quarters of patients with a 99% negative predictive value could reduce cystoscopies, particularly in low-risk non-visible haematuria. But it missed one in nine cancers, including one advanced tumour, and as a commercial assay it needs independent validation in other populations. It is not yet a replacement for cystoscopy in visible haematuria.
- Do not use a negative urine biomarker result to skip cystoscopy in visible haematuria.
- Consider urine biomarker triage, where available, for lower-risk non-visible haematuria under local protocols.
- Remember the test missed about one in nine cancers in this study.
- Interpret positive results with care: only about one in four positives had a tumour.
Why it matters
Most haematuria referrals do not have cancer, and safely reducing cystoscopies is a real goal for services.
Don't overread it
Observational, in a cohort of 54 tumours; it missed one advanced cancer.
The statistics, in plain English
A 99% negative predictive value depends on how rare cancer is in the group tested — here about 8%. In a higher-risk group, the same test would miss proportionally more. Sensitivity of 89% means 6 of 54 tumours were missed.
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