Early Alzheimer's Test Dementia Risk Amyloid beta (A-β) Protein Test Kit

【INTENDED USE】

  The Amyloid β Protein (Aβ) Rapid Test Cassette is a rapid chromatographic immunoassay for the qualitative detection of Amyloid β 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.

【PRINCIPLE】

  The Amyloid β Protein (Aβ) Rapid Test Cassette (Urine) is a qualitative membrane-based immunoassay for the detection of Aβ 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-ß coated colloid gold particles in the conjugate pad and the mixture migrates upward on the membrane chromatographically by capillary action to react with amyloid-ß 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.

【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 β 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.