Alzbeta Hulikova and Pawel Swietach at Oxford’s Department of Physiology, Anatomy and Genetics (DPAG), in collaboration with Evelina’s Children Hospital in London, Oxford University Hospitals, Cayetano Heredia University in Peru, Mahidol Oxford Tropical Medicine Research Unit in Thailand and Chattogram Medical College Hospital in Bangladesh have discovered a novel biomarker of intravascular haemolysis called CA1 that is excreted into urine for rapid and cost-effective detection. Working with Camtech Innovations, the licensee of Oxford’s technology, our team developed and tested a lateral flow device for detecting the biomarker.
Intravascular haemolysis occurs when red blood cell rupture inside blood vessels. This event is a sentinel of disease-related triggers affecting an estimated ~800 million people, and contributes to complications in malaria, sickle cell disease and newborn illness. Common blood tests used to infer haemolysis can be variably sensitive and hard to deploy in low-resource settings, where laboratory infrastructure and reliable venous sampling are limited.
To address the unmet need for accessible diagnostics, the team tested carbonic anhydrase 1 (CA1), a protein abundant inside red blood cells. When cells rupture inside blood vessels, CA1 is filtered by the kidneys and appears in urine, creating a practical readout that can avoid venepuncture and reduce reliance on laboratory infrastructure. In a multi-centre study spanning the UK, Bangladesh and Peru, researchers assessed urinary CA1 in participants across a range of haemolysis-triggering conditions. CA1 was negligible in controls and increased with haemolytic risk, with the highest levels in malaria and sickle cell disease. In severe malaria, urinary CA1 detected haemolysis in some patients whose plasma free haemoglobin remained below standard diagnostic thresholds. In newborn intensive care, CA1 trajectories stratified infants by haemolytic severity and captured information not resolved by bilirubin trajectories, including where transcutaneous bilirubin readings can be less reliable in darker skin tones.
To translate the finding into an accessible tool, the researchers partnered with Camtech Innovations to develop a urine lateral-flow device (LFD). The second prototype achieved >90% sensitivity and specificity against laboratory benchmarks, supporting a route to a low-cost, rapid test suitable for bedside and community use.
Lead investigator, Pawel Swietach, says “A urine-based lateral-flow test for CA1 could make haemolysis screening practical in settings where lab testing is limited. Earlier detection can support safer decisions for newborns and for patients with infections or inherited blood disorders.”
The study was led by Arjen Dondorp, Katherine Plewes, Francisco Villafuerte, Dionicia Gamboa, Noemi Roy, and Hammad Khan. The University of Oxford has entered a licensing agreement with Camtech Diagnostics to support further development and evaluation of the CA1 LFD. This work was supported by the European Research Council and funded by UK Research and Innovation (ERC and MSCA Other Guarantee Calls; EP/X021548/1) and the Medical and Life Sciences Translational Fund of the University of Oxford.
Read the paper here