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BK virus haemorrhagic cystitis after allogeneic HSCT

BK virus haemorrhagic cystitis after allogeneic stem cell transplantation

Nephropathy in kidney transplant recipients is not the only complication of BK polyomavirus. In allogeneic haematopoietic stem cell transplant recipients, reactivation of the same virus causes haemorrhagic cystitis. It is a second indication, with a different diagnostic logic.

A distinct clinical problem

Haemorrhagic cystitis following allogeneic haematopoietic stem cell transplantation is a significant event that lengthens hospital stays and increases the burden of care. Its causes can be multiple, but BK polyomavirus is the leading one by frequency.

The difference from kidney transplantation matters. In nephrology, the question is one of surveillance in asymptomatic patients: detecting reactivation before it causes damage. In haematology, the question is one of confirmation: the patient already has symptoms, and clinicians need to establish quickly whether BK virus is the cause.

The limitation of PCR in this setting

The clinical tool widely used today is PCR-based detection of the viral genome in urine. It poses a particular problem here: almost all allogeneic transplant recipients shed BK virus in urine, with or without cystitis. A positive PCR therefore does not efficiently distinguish the patient whose symptoms are caused by BK virus from the one in whom the virus is merely a bystander.

The published data confirm this: in a series of 49 patients, the specificity of urine PCR for haemorrhagic cystitis was 62.1% and its positive predictive value 64.5%.

What antigen detection adds

In that same series, the rapid antigen test underpinning SPyDiag’s programme outperformed PCR.

Specificity: 86.2% versus 62.1%. Positive predictive value: 82.6% versus 64.5%. Nineteen of the twenty patients with haemorrhagic cystitis were detected, i.e. 95%.

The explanation lies in the nature of the marker. PCR detects viral genomes, whose presence is not always associated with true replication. An antigen test directed against the VP1 capsid protein detects assembled viral particles — the product of active replication. In an indication where viral shedding is near-universal, that distinction becomes decisive.

The study authors conclude that this tool could be implemented as a point-of-care test to rapidly confirm or rule out suspected BKPyV haemorrhagic cystitis after HSCT.

One target, two populations

The VP1 protein is the same in both settings. That is what allows a single technology to address two immunocompromised populations with distinct clinical needs: kidney graft surveillance on one side, diagnostic confirmation in haematology on the other.

Methodological detail and full results are on the analytical and clinical data page, and complete references on the Publications page.

Status. The results cited come from a retrospective diagnostic study posted as a preprint (Brochot et al., 2025, DOI 10.2139/ssrn.5360002), approved by the local institutional review board under reference PI2022_843_0079. UriFastBK is not currently a CE-marked device.

Information intended for professionals. It does not replace medical advice or the protocols in force at your centre.