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With the increasing prevalence of Alzheimer’s Disease (AD) worldwide, methods of earlier detection are more vital than ever to facilitate timely early intervention. The detection of specific β-amyloid protein (Aβ) in body fluids is an important method to assist in the diagnosis of Alzheimer's disease and chronic neurodegenerative diseases with abnormal deposition of specific Aβ-amyloid protein.
It has been found that human urine contains soluble Amyloid-beta, and it has been proved to be a reliable diagnostic assay for individuals with Mild Cognitive Impairment (MCI) or Alzheimer’s Disease (AD). The novel One Step Dementia Risk Test Kit is the world's first Alzheimer’s Disease urine test early screening tool which can help to easily detect Aβ in urine by using a variety of anti-Aβ antibodies combined with mature colloidal gold detection technology.
While performing the clinical testing, it was found that the One Step Dementia Risk Test Kit could detect most cognitive impairments and Alzheimer's disease in the participants, with a sensitivity of 75.7%, and a specificity of 91.03%. The product has been clinically verified, and the verification conclusion is that One Step Dementia Risk Test Kit has a detection rate of more than 90% for early AD.
Dementia is a group of symptoms and is caused by different diseases that damage nerve cells in the brain. It is not a natural part of aging. Dementia affects everyone differently, however each type has some common early symptoms. It is progressive, which means symptoms may be relatively mild at first, but they get worse over time:
There are many types of dementia but Alzheimer’s disease is the most common. While dementia is a general term, Alzheimer's disease is a specific brain disease. It affects the part of the brain associated with learning first, early symptoms often include changes in memory, thinking and reasoning skills. As the disease progresses, symptoms become more severe and include confusion, language problems, spatial disorientation, mood instability, changes in behavior and other challenges.
The purpose of this medical test is the identification of people at high risk of dementia as well as diagnosis and prognosis of individuals with cognitive decline. This product is an in vitro auxiliary screening device for risk alert of dementia (including but not limited to Alzheimer's disease). It may be used to evaluate brain health status and assist doctors to decide whether further tests are required.
The test can be applied to the regular physical examination population over 45 years old.
It is recommended for the individuals characterized by:
People to be excluded from target audience:
Important: this is a qualitative test, not a confirmatory/diagnostic test.
Normal healthy people without cognitive impairment should be negative, and patients with mild cognitive impairment will be positive or strongly positive in the early and middle stages.
Positive: purple-red bands at both the test area (T) and the control area (C). The concentration level of beta-amyloid in the subject's body is currently abnormal. It is recommended to check the risk factors and improve the living habits, and then recheck in 3 to 6 months. If the recheck result is positive, there is a risk of developing AD. If there are clinical symptoms, further examination or intervention can be carried out. If the recheck result is negative, it means that the concentration level of beta-amyloid in the body is already within the normal range. It is recommended to maintain the existing lifestyle and test regularly every year.
Negative: a purple-red band at the control area (C), and no purple-red band at the test area (T). The concentration level of beta-amyloid in the subject's body is currently within the normal range. It is recommended to maintain the existing lifestyle and test regularly every year.
Invalid: no purple-red band at the control area (C), indicating that the operation is wrong, or the test kit has deteriorated.
Please do not open the inner package before you are ready. After the kit is taken out of the inner packaging, it should be used within 1 hour to avoid moisture. The used test kit should be treated as biological waste and disposed of in accordance with relevant regulations.
If the temperature is higher than 30°C or the humidity is greater than 75%, it should be used as soon as it is opened as much as possible.
This product is for in vitro diagnostic use only; it is suitable for urine specimens, and abnormal results may occur when testing with other specimens or solutions.
The kit is a disposable item and cannot be reused. Before use, check the tightness of the aluminum foil bag. If there is a problem with the seal, it cannot be used.
The quality control line is the effective mark of the reagent. The depth of its color does not represent the quality of the reagent. As long as its color is clearly visible, it indicates that the reagent is effective.
The detection of β-amyloid protein content in urine is only one of the indicators for clinicians to conduct further diagnostic tests for Alzheimer's disease. It is recommended that clinicians make a comprehensive judgment tool based on the patient's physical signs, medical history, examinations and other markers.
One Step Dementia Risk Test Kit (colloidal gold lateral immunochromatography) uses colloidal gold lateral immunochromatography technology. The detection area (T) of the nitrocellulose membrane of the kit is coated with Aβ-amyloid phagocytosis polypeptide (PPP), and the quality control area (C) is coated with sheep anti-mouse IgG polyclonal antibody. The kit utilises 15-20 nm colloidal gold particles coupled with anti-Aβ monoclonal antibody, to capture Aβ in urine and form a particle-Aβ complex. The kit then detects the complex with Aβ-binding phagocytosis-promoting polypeptide (PPP). During detection, excessive Aβ binds to the anti-Aβ antibody-coated colloidal gold nanoparticles in the conjugate pad to form an ‘Aβ-monoclonal antibody-colloidal gold complex,’ which is then stopped by the T-line containing PPP and forms a purple mark.
If there is no Aβ or very little Aβ in the urine sample, the kit will not react to form a purple marker at the T-line, and only the quality control area (C) will be colored. The purple line appears in the control area (C) regardless of whether Aβ is present in the urine.
The best storage condition of the kit is 4-25 °C (room temperature) , store in a dry place, away from light and heat, and prohibit from freezing. In extreme weather, certain protective measures should be taken to avoid high temperatures or freezing & thawing. And confirmed sealed state, valid for 18 months.
This is a more cost-efficient and easily accessible tool to assess an individual’s risk of cognitive decline. The Dementia Risk Test is a safe, accurate and convenient prediction and prognosis assessment tool for Alzheimer’s Disease.
The new Dementia Risk assessment test kit has been developed by Qankorey Biotechnology Co. Ltd. working closely with the Florey Institute of Neuroscience and Mental Health at the University of Melbourne, Australia. The emergence of this innovative technology is expected to change the current dilemma of AD diagnosis and prediction, which may subsequently allow patients to have more timely and effective treatment management.
Expiration date: July 2026
