A Ten-Minute Urine Test for Dementia Risk

One Step Dementia Risk Test Kit

The One Step Dementia Risk Test Kit is a lateral flow device that detects amyloid-beta (Aβ) concentration in urine, a key biomarker for Alzheimer’s disease. The entire process takes ten minutes from a fresh midstream sample.

With a sensitivity of 79.14% and specificity of 91.03%, the kit is not diagnostic but serves as an auxiliary screening tool. It flags risk for patients aged 45 and older, prompting further clinical evaluation only when indicated.

The core technology is a self-developed Aβ monoclonal antibody using a polymer sandwich method. This proprietary reagent is the product’s key differentiator and the main cost driver in manufacturing.

Target users include hospitals, clinics, and health screening centers — any setting where routine blood or urine work is already performed. The kit requires no special equipment, removing a major infrastructure barrier in community-level facilities.

China’s IVD sector has invested heavily in antibody development and lateral flow manufacturing over the past decade. This kit reflects that capacity now being applied to neurodegenerative disease, a field historically dominated by Western diagnostic firms.

The product is CE and NMPA certified. Its main commercial challenge is not technical, but procedural: integrating a dementia screen into standard physical exams for the over-45 population will require new clinical workflows.

The real innovation here is not the test itself but the operational logic behind it. By turning dementia risk into a ten-minute urine strip, the kit repositions screening from neurology departments to primary care — where most patients actually sit.

Why it matters:
For procurement managers and health system operators, this kit offers a low-cost, scalable entry into cognitive health screening. It reduces dependence on PET scans and lumbar punctures, cutting both per-patient cost and infrastructure requirements.

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