Non-invasive sampling
Uses a urine specimen for amyloid-β precursor-fragment detection.
1 test
Urine-based dementia risk assessment
One Step Dementia Risk Test Kit
A qualitative professional-use IVD for detecting amyloid-β protein precursor fragments in human urine to support early risk assessment.
Amyloid-β precursor fragments
For professional in vitro diagnostic use only. This risk-assessment test is not a standalone diagnosis.Overview
1 target. One streamlined test.
The One Step Dementia Risk Test Kit uses colloidal gold lateral immunochromatography to qualitatively detect amyloid-β (Aβ) protein precursor fragments in human urine. This biomarker is associated with an increased risk of Alzheimer’s disease and other neurodegenerative conditions. The test is intended for healthcare professionals to support early risk assessment and help determine whether further diagnostic evaluation is warranted; it is not a standalone diagnosis.
Key features
Designed for speed, clarity, and practical use.
10-minute result
Provides a qualitative visual result in approximately 10 minutes.
Clinically validated
The supplied 440-participant study reports 79.14% sensitivity and 91.03% specificity.
CE-marked IVD
Identified in the supplied materials as an IVDD 98/79/EC legacy device under Article 110(3) IVDR.
Applications
Flexible across qualified research settings.
The kit is intended for qualified organizations including medical institutions, research organizations, clinics, and care facilities. It is not sold for personal consumer use.
Early dementia-risk assessmentScreening of high-risk patients aged 45+Professional point-of-care workflowsReferral support for further diagnostic evaluation
Technical specifications
Product details at a glance.
Test formatQualitative lateral-flow in vitro diagnostic test
TechnologyColloidal gold lateral immunochromatography
TargetAmyloid-β (Aβ) protein precursor fragments
SpecimenHuman urine
Time to result10 minutes
Pack size1 test per box
Intended userHealthcare professionals
Clinical study size440 participants
Observed agreement87.27% (384/440)
Kappa value0.7043
Regulatory statusCE-marked; IVDD 98/79/EC legacy device, Article 110(3) IVDR
Clinical performance data
Measured performance for One Step.
Values below reproduce the supplied clinical performance summary for One Step. See the downloadable data sheet for details and confidence intervals where provided.
| Target | Sensitivity | Specificity | Total agreement |
|---|---|---|---|
| Amyloid-β precursor fragments | 79.14% | 91.03% | 87.27% |
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