As Alzheimer’s Disease (AD) continues to rise globally, early detection is becoming increasingly important. Diagnosing the condition early allows for timely intervention, which can help slow progression and enhance quality of life. A key diagnostic approach involves detecting specific β-amyloid proteins (Aβ) in body fluids, which are closely linked to the development of Alzheimer’s and other neurodegenerative diseases.

Recent studies have shown that human urine contains soluble Amyloid-beta, making it a reliable biomarker for diagnosing Mild Cognitive Impairment (MCI) or Alzheimer’s Disease. The One Step Dementia Risk Test Kit is the first urine-based early screening tool for Alzheimer’s, utilizing anti-Aβ antibodies and advanced colloidal gold detection technology to effectively identify Aβ levels in urine.

Clinical testing of the kit has demonstrated impressive accuracy, with a sensitivity of 75.7%, specificity of 91.03%, and an early detection rate of over 90% for Alzheimer’s Disease. Clinically validated, this test serves as a dependable tool for assessing dementia risk and cognitive decline.

Test Principles: How It Works

The One Step Dementia Risk Test Kit uses colloidal gold lateral immunochromatography technology. The nitrocellulose membrane consists of two key areas: the detection area (T), which is coated with Aβ-amyloid phagocytosis polypeptide (PPP), and the quality control area (C), which is coated with anti-mouse IgG polyclonal antibody.

During the test, Aβ in the urine binds to colloidal gold nanoparticles coated with anti-Aβ monoclonal antibodies. This forms an Aβ-antibody-gold complex, which is captured at the T-line, creating a visible purple mark. If Aβ levels are low or absent, only the control (C) line will appear.

Who Should Use the Test?

This test is recommended for individuals aged 45 and older, particularly those with:

• A family history of dementia
• Memory impairment or suspected cognitive decline
• Cardiovascular or cerebrovascular diseases (stroke, cerebral hemorrhage, cerebral infarction)
• Chronic conditions (hypertension, diabetes, high cholesterol, sleep apnea, homocysteine deficiency)
• Mental health conditions (anxiety, depression, high-stress occupations)
• Lifestyle risks (smoking, excessive alcohol consumption, obesity, lack of exercise, chronic sleep deprivation)

Who Should NOT Use This Test?

This test is not recommended for individuals who:

• Have been diagnosed with severe AD or dementia
• Have renal impairment
• Have abnormal urine pH levels (too acidic or alkaline)
• Are experiencing hematuria or proteinuria

How to Use the One Step Dementia Risk Test Kit

1. Open the foil pouch and remove the test strip.
2. Using the provided eyedropper, add 4 drops (100 µL) of fresh urine into the sample well.
3. Place the test cassette on a flat surface and wait 10 minutes before reading the results. (Results are unreliable after 15 minutes.)

Interpreting the Results

A positive result is indicated by the appearance of two purple-red bands in the T and C areas, which suggests abnormal beta-amyloid levels. In this case, it is recommended to monitor risk factors, improve lifestyle, and retest in 3 to 6 months. If the result is positive again or symptoms develop, seeking medical advice is advised.

A negative result is indicated by a single purple-red band in the C area, indicating that beta-amyloid levels are within the normal range. It is recommended to maintain a healthy lifestyle and test annually.

An invalid result occurs when no purple-red band appears in the control (C) area, indicating that the test was improperly conducted or the kit may be defective. In this case, it is recommended to retest using a new kit.

What’s Included in the Kit?

• Test cassette
• Eyedropper
• Instruction manual (English)

Trademark and Patents

The One Step Dementia Risk Test is a game-changing, cost-efficient tool for assessing an individual’s risk of cognitive decline. Developed by Qankorey Biotechnology Co. Ltd. in collaboration with the Florey Institute of Neuroscience and Mental Health at the University of Melbourne, Australia, this innovation is set to revolutionize Alzheimer’s screening and prediction.

Expiration date: July 2026