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Qualitative Test Cassette for Amyloid-β Protein

Important step forward in risk detection, aiming at early intervention for Alzheimer’s disease

Important step forward in risk detection, aiming at early intervention for Alzheimer’s disease

2.000.000 VNĐ

Packaging: 1 piece/box

For detailed information, please refer to the secondary label on the product packaging

Registration Number: 250000641/PCBB-HCM

Official Document Number for Advertising Content and Format: 004/25/OSDTK/VB-AD

VINA BIOCARE VIETNAM is the exclusive importer, distributor, and marketer of the qualitative amyloid-β protein test kit (One Step Dementia Risk Test Kit) in Vietnam, ensuring genuine origin and certified product quality

Purpose of use

The One Step Dementia Risk Test Kit is a screening tool that helps to predict the risk of dementia (including but not limited to Alzheimer’s disease). This kit is used for the qualitative analysis of biochemical markers of amyloid-β protein in human urine. It can be used to assist physicians in deciding whether further testing is required, assessing disease progression and treatment effectiveness in relation to brain health status.

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Qualitative Amyloid-β Protein Test Strip

Urine Screening Test to Aid in Diagnosing Alzheimer’s Dementia Risk

A Major Step Forward in Risk Detection for Early Intervention in Alzheimer’s Dementia

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World’s First
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Non-invasive – Easy to Use
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Rapid Results (within 10 minutes) – High Accuracy
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Approved by the Ministry of Health, Registration No.: 20000641/PCBB-HCM
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Clinically Proven
Technical Specifications

 

Product Name Qualitative Test Cassette for Amyloid-β Protein
Model One Step Dementia Risk Test Kit

(Colloidal Gold Lateral Immunochromatography)
Certifications CE, NMPA
Packaging 1 unit/box

Main components: The kit includes a colloidal gold test strip sealed in a foil pouch, along with a disposable plastic dropper and a desiccant. The “Instructions for Use” are also included in the package.
Registration number: 250000641/PCBB-HCM
Owner: VINA BIOCARE Vietnam Co., Ltd.
Address: B10.17, 10th Floor (Officetel), Sunrise Cityview, No. 33 Nguyen Huu Tho Street, Tan Hung Ward, District 7, Ho Chi Minh City, Vietnam
Phone: 0798674111
Email: admin@vinabiocare.com
Manufacturer: Hunan Qankorey Biotechnology Company Ltd.
Address: 12F, Building 15, No. 188 Middle Huanbao Road, Yuhua District, Changsha, Hunan, 410116, China
Country of origin: China
Quality management system applied: ISO 13485:2016
Advertising approval document number: 001/25/OSDTK/VB-AD

The One Step Dementia Risk Test Kit is a screening tool that helps to predict the risk of dementia (including but not limited to Alzheimer’s disease). This kit is used for the qualitative analysis of biochemical markers of amyloid-β protein in human urine. It can be used to assist physicians in deciding whether further testing is required, assessing disease progression and treatment effectiveness in relation to brain health status.

– Sample collection:

+ This kit is designed for collecting human urine samples.

  1. The sample must be collected in a clean, dry container. Urine can be collected at any time of the day. Fresh urine does not require special processing. It is recommended to drink 200–300 mL of water 30–60 minutes before sample collection.
  2. The sample should be used as soon as possible after collection and should not be stored at room temperature for more than two hours. If refrigerated, it may be stored at 2–8 °C for up to six hours before testing. Refrigerated samples should be brought to room temperature and mixed thoroughly before testing.
  3. Do not use frozen and thawed samples unless for research purposes.

– Test procedure:

This kit can be used by consumers or healthcare professionals in clinical facilities, pathology laboratories, and research institutes. Before testing, read the “Instructions for Use” and allow the test kit and other necessary items to reach room temperature. Do not open the foil pouch until ready to perform the test, and use the kit within 1 hour after opening. If the ambient temperature exceeds 30 °C or humidity exceeds 75%, the test should be performed immediately after opening.

  1. Tear open the foil pouch and remove the test cassette.
  2. Using the provided dropper, collect approximately 100 µL (~4 drops) of fresh urine and slowly add the drops into the sample well of the cassette.
  3. Place the cassette on a flat surface for 10 minutes before reading the results. Results are unreliable after 15 minutes.

– Interpretation of results:

+ Positive: Two reddish-purple lines appear—one in the test region (T) and one in the control region (C).

+ Negative: One reddish-purple line appears in the control region (C) with no line in the test region (T).

+ Invalid: No reddish-purple line appears in the control region (C), indicating an operational error or a damaged test cassette.

– Storage conditions and shelf life:

+ Store at 4–25 °C. Shelf life: 18 months.

+ For single use only.

+ Store in a dry place, away from light, high temperatures, and do not freeze. Under extreme weather conditions, protective measures should be taken to prevent exposure to high temperatures or freeze–thaw cycles.

Quality Certification

QANKOREY is proud to have achieved international quality certifications such as ISO 13485 and CE (Conformité Européenne)

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Q&A

01 Which age group or target population is the test kit (test strip) suitable for?

The product is recommended for individuals over 45 years of age as a screening tool for dementia risk.

02 Do medications affect the results of the test kit (test strip)?

  • To avoid interference from vitamin C’s reduction–oxidation (REDOX) reactions with the product, patients should refrain from taking vitamin C–containing medications or consuming vitamin C–rich fruits within 12 hours prior to testing. Failure to comply may inactivate the colloidal gold in the strip, leading to false-negative results.
  • This test should also be avoided during treatment with high doses of anti-inflammatory, analgesic, antibiotic, or other medications, as these may increase urinary protein levels. If the urine protein level exceeds “+” on testing, it may interfere with the reaction of the product.

03 Which types of dementia can this kit screen for?

Dementia Type Identification:

  • The biomarker detected by this product is Aβ (Total Amyloid β), so the main types of dementia involved are: Alzheimer’s Disease and Vascular Dementia.

04 What are the storage requirements for the product?

The best storage condition of the kit is 4-25℃ (room temperature) cool storage, sealed state has been confirmed, valid for 18 months.

05 What are the general operational requirements for the test kit (test strip)?

  • The amount of sample to be added is approximately 100 µL of fresh urine (equivalent to approximately 4 drops using the supplied dropper). Do not drop too much, the drop rate should be controlled correctly at the sample well position of the kit. (Must use a sterile disposable dropper pre-packaged in the original packaging – do not replace it with another device to avoid volume errors.)
  • Place the test strip horizontally on a flat surface for 10 minutes to read the result. Kits with a reaction time exceeding 15 minutes will not be considered valid for interpretation of results.

06 What should I do if the result is positive?

Positive: Aβ levels are higher than normal, indicating a high risk of developing AD (Azheimer’s disease).

Advice:

1. Please check your underlying risk factors accordingly and adjust your lifestyle.

(Reduce alcohol and smoking, get quality sleep, etc.)

2. It is recommended to repeat 1 or 2 times in 2 months.

3. If the test is still positive, you should see a doctor for further testing.

07 If the result is negative, do I need to repeat the test?

  • Negative: Aβ levels remain normal.
  • Advice: If negative, re-monitor every 6-12 months.

08 What results can I get when I test with a test kit?

  • Positive: Purple-red bands in both the test region (T) and the control region (C).
  • Negative: One purple-red band in the control region (C) and no purple-red band in the test region (T).
  • Invalid: No purple-red band in the control region (C), indicating malfunction or damage to the test kit.

09 What are the requirements for a urine sample?

The test kit (test strip) is designed for human urine samples.

  1. The sample must be collected in a clean, dry container. Urine can be collected at any time of the day. Fresh urine does not require any processing. It is recommended to drink 200–300 mL of water 30–60 minutes before collecting the urine sample.
  2. Samples should be used as soon as possible after collection and should not be stored at room temperature for more than two hours. If refrigerated, they may be stored at 2–8 °C for up to six hours before testing. Refrigerated samples should be allowed to reach room temperature and mixed thoroughly before testing.
  3. Do not use frozen and thawed samples unless for research purposes.

10 Is the product FDA approved?

The product is currently in the process of being submitted for FDA approval. The product has been patented in Australia and has been granted an international PCT patent in China, Luxembourg, Europe and Japan