Why Early Detection of Alzheimer’s Disease Matters

With the rising prevalence of Alzheimer’s Disease (AD) worldwide, early detection is more crucial than ever. Identifying the condition at an early stage enables timely intervention, which can slow disease progression and improve quality of life. One of the key diagnostic methods involves detecting specific β-amyloid proteins (Aβ) in body fluids, which play a significant role in the development of Alzheimer’s and other neurodegenerative diseases.

Urine-Based Alzheimer’s Screening: A Breakthrough in Early Diagnosis

Recent research has confirmed that human urine contains soluble Amyloid-beta, making it a reliable biomarker for diagnosing individuals with Mild Cognitive Impairment (MCI) or Alzheimer’s Disease. The One Step Dementia Risk Test Kit is the world’s first urine-based early screening tool for Alzheimer’s. This innovative test leverages anti-Aβ antibodies combined with mature colloidal gold detection technology to efficiently identify Aβ levels in urine.

Clinically Validated Accuracy

Clinical testing of the One Step Dementia Risk Test Kit demonstrated impressive accuracy:

• Sensitivity: 75.7%
• Specificity: 91.03%
• Early Detection Rate: Over 90% for AD

This test has been clinically verified, making it a reliable auxiliary screening device for assessing dementia risk and cognitive decline.

Understanding Dementia and Alzheimer’s Disease

What is Dementia?

Dementia is a broad term for symptoms caused by diseases that damage brain nerve cells. It is not a normal part of aging. While every individual experiences dementia differently, common early symptoms include:

• Memory loss

• Confusion and difficulty with daily tasks

• Language and comprehension problems

• Behavioral changes

What is Alzheimer’s Disease?

Alzheimer’s disease is the most common type of dementia. It primarily affects the brain areas responsible for learning, with early symptoms including memory decline, impaired reasoning, and disorientation. As the disease progresses, individuals may experience severe cognitive and behavioral challenges.

Who Should Use the One Step Dementia Risk Test Kit?

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

Positive Result

• Appearance: Two purple-red bands (T & C areas)

• Interpretation: Abnormal beta-amyloid levels detected.

• Recommendation: Monitor risk factors, improve lifestyle, and retest in 3-6 months. If positive again or symptoms appear, seek medical advice.

Negative Result

• Appearance: One purple-red band (C area only)

• Interpretation: Beta-amyloid levels are within the normal range.

• Recommendation: Maintain a healthy lifestyle and test annually.

Invalid Result

• Appearance: No purple-red band at the control (C) area.

• Interpretation: The test was improperly conducted or the kit is defective.

• Recommendation: Retest with a new kit.

Precautions & Storage Guidelines

• Do not open the inner packaging until ready to use.

• Use within 1 hour of opening to prevent moisture exposure.

• Dispose of used kits as biological waste according to local regulations.

• Store at 4-25°C in a dry place, away from direct heat and light.

• Avoid freezing and thawing cycles.

• Shelf life: 18 months (when stored properly).

Test Principles: How It Works

The One Step Dementia Risk Test Kit employs colloidal gold lateral immunochromatography technology. The nitrocellulose membrane features:

• Detection area (T): Coated with Aβ-amyloid phagocytosis polypeptide (PPP)

• Quality control area (C): Coated with anti-mouse IgG polyclonal antibody

During the test, the Aβ in urine binds to colloidal gold nanoparticles coated with anti-Aβ monoclonal antibodies. The resulting Aβ-antibody-gold complex is captured at the T-line, forming a visible purple mark. If Aβ levels are low or absent, only the control (C) line appears.

Why Choose the One Step Dementia Risk Test Kit?

✔ Non-invasive & convenient – No need for blood tests. ✔ Clinically verified accuracy – Sensitivity of 75.7% and specificity of 91.03%. ✔ Early detection advantage – Identifies risk before severe symptoms develop. ✔ Affordable alternative – Cost-effective compared to traditional diagnostic methods.

The One Step Dementia Risk Test Kit 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.

By enabling earlier detection and intervention, this test empowers individuals and healthcare providers to take proactive steps in managing brain health.

What’s Included in the Kit?

• Test cassette
• Eyedropper
• Instruction manual (English)

Expiration date: July 2026

Take control of your cognitive health today with the One Step Dementia Risk Test Kit. Early detection can make all the difference.