Dementia Risk Amyloid β Protein Rapid Test
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ysen Biotech Index of Symbols Hysen Biotech. Inc Rm 1209, Desian Plex, 424, Yangcheon-ro, Gangseo-gu Seoul, 07573, Korea | Ec | BEp | Riomavix S.L. LEC .Iae'’ -1 Calle de Almansa 55, 1D, Madrid 28039 Spain Amyloid p Protein (Ap) Rapid Test Cassette Package Insert Cat.: HAM-102 Specimen: Urine Version: A Effective Date: 2023-10 A rapid test for the qualitative detection of Amyloid p (AP) in urine. For in professional in vitro diagnostic use only [INTENDED USE] The Amyloid p Protein (AP) Rapid Test Cassette is a rapid chromatographic immunoassay for the qualitative detection of Amyloid P Protein in urine for early warning of the risk of dementia as an in vitro screening aid. The test can be used to assess brain health and help doctors determine whether further testing is necessary. [SUMMARY] Amyloid p Protein (AP) is a 39-43 amino acid peptide produced by the proteolytic cleavage of amyloid precursor protein by P-secretase and Y-secretase. Ap aggregates were described as the main constituent of neocorticalneuritic plaques, characterizing brain aging and constituting a pathological hallmark of Alzheimer's disease. As normal urine contains very little background proteins, the increased levels of AP have better chance to be detected in urine, which may reflect brain health status.Middle-aged and elderly people with constant brain sub-health status are likely to develop brain health problems including dementia late in their life if no intervention is provided. [PRINCIPLE] The Amyloid P Protein (AP) Rapid Test Cassette (Urine) is a qualitative membrane-based immunoassay for the detection of Ap in urine. It consists of sample pad, conjugate pad, membrane and absorbent pad laid in sequence on a polyvinyl chloride support plate. In this test procedure, capture reagent is immobilized in the test line region of the test. During testing, the urine specimen is dropped into the specimen well, it reacts with monoclonal antibodies recognizing amyloid-U coated colloid gold particles in the conjugate pad and the mixture migrates upward on the membrane chromatographically by capillary action to react with amyloid-U binding polymers/antibodies pre-located on the membrane and generate a colored line. The presence of this colored line in the test line region indicates a positive result, while its absence indicates a negative result. To serve as a procedural control, a colored line will always appear in the control line region, indicating that proper volume of specimen has been added and membrane wicking has occurred. [MAIN COMPONENTS] This product contains a test cassette sealed in a foil pouch with a disposable plastic pipette and a desiccant. The "package Insert" is also included in the package. [PRECAUTIONS] 1 .For in vitro diagnostic use only. Do not use after expiration date. 2.It is applicable to urine specimens, abnormal results may occur when using other specimens or solutions for testing. 3.For single in-vitro diagnostic use only.The sealed pouch should be checked before use. Do not use it if the seal is broken. 4.Do not leave the cassette open to air for more than one hour. After use, the test shall be treated as a biological product contaminant according to relevant provisions. 5.The control line is an indication that the device is working as intended. However, the colour development depth does not necessarily represent the quality of the device. [STORAGE AND STABILITY] The can be stored at 4-25 °C. The test cassette is stable through the expiration date. The test must remain in the sealed pouch until use. Do not use beyond the expiration date. Store in a dry place, away from light and heat. DO NOT FREEZE. In extreme weather, certain protective measures should be taken to avoid high temperatures. [SPECIMEN COLLECTION AND PREPARATION] Urine Collection The urine specimen must be collected in a clean and dry container. Urine collected at any time of the day may be used. It is recommended to drink 200-300 mL of water 30-60 min prior to urine collection. Specimen Storage Samples should be used as soon as possible after collection and should not be stored at room temperature for more than two hours. Urine specimens may be stored at 2-8° C for up to 48 hours prior to testing. For long-term storage, specimens may be frozen and stored below -20°C. Frozen specimens should be thawed and mixed before testing. [MATERIALS] Materials Provided • Test Cassette • Disposable urine cup • Disposable plastic pipette • Package Insert Materials Required But Not Provided • Timer [DIRECTIONS FOR USE] Allow the test, urine specimen, and/or controls to reach room temperature (15-30° C) prior to testing. 1. Bring the pouch to room temperature before opening it. Remove the test cassette from the sealed pouch and use it as soon as possible. 2. Place the cassette on a clean and level surface. Hold the dropper vertically and transfer 4 full drops of urine (approximately 100ul) to the specimen well of the cassette, and then start the timer. 3. Wait for the colored line(s) to appear. Read results at 10 minutes. Do not interpret the result after 15 minutes. [INTERPRETATION OF RESULTS] (Please refer to the illustration above) POSITIVE: *Two distinct colored lines appear. One colored line should be in the control region (C) and another colored line should be in the test region (T). *NOTE: The intensity of the color in the test line region (T) will vary depending on the concentration of Amyloid p protein present in the specimen. Therefore, any shade of color in the test region should be considered positive. NEGATIVE: One colored line appears in the control region (C). No apparent colored line appears in the test region (T). INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test cassette. If the problem persists, discontinue using the test kit immediately and contact your local distributor. [LIMITATIONS] 1.The Amyloid p Protein Rapid Test Cassette is a preliminary qualitative test, therefore, the quantitative value of Ap in human urine can be determined by this test. 2.The test results of this cassette are only a limited reference for clinicians. For the diagnosis of dementia or Alzheimer's disease, clinicians are advised to make a comprehensive judgment based on the patient's signs/symptoms, medical history and other laboratory findings. 3.A false negative or invalid result may occur for urine samples with pH<3 or pH> 9. Urine analysis prior to testing is recommended to avoid interference. 4.Renal dysfunction, acute infections - particularly urinary tract infections, brain tumors, brain trauma and other central nervous system diseases such as cerebrovascular disease, Parkinson's disease, encephalitis, epilepsy, etc.; systemic diseases known to cause cognitive disorder such as hypothyroidism, VitB12 or folic acid deficiency, neurosyphilis, HIV infection, severe anaemia, hepatic encephalopathy, carbon monoxide poisoning, etc.; substance factors such as drug or alcohol abuse; relevant risk factors such as a history of hypertension, hyperlipidemia, diabetes, long-term insomnia etc. may show positive results as well.