One Step HAV IgM Rapid Screen Test
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One Step HAV IgM Rapid Screen Test For the qualitative detection of Antibody against HAV in human serum
Intended Use The HAV test is a rapid qualitative lateral flow test designed for the qualitative detection of hepatitis A infection (HAV), Principles of the Test The quick one-step test utilizes a sandwich immunoassay system and the immunochromatographic detection assay, to be performed in one assay. If HAV antibody is present in the sample in concentration above the detection, a labeled antigen-dye complex will be formed. This complex is then captured by antibody immobilized in the Test Zone of the membrane, producing a visible pink-rose color band on the membrane. The color intensity will depend on the concentration of HAV antibody in the sample. STORAGE The pouched Cassette should be stored at 4~30℃ in the sealed pouch before expiration date. Materials Provided Test devices Disposable specimen droppers Buffer Package insert PROCEDURE Figuer 1 1. Open a pouch containing a cassette, lay the cassette. 2. Carefully apply 5ul of sample onto 5ml buffer(1:1000), then drop 75ul(3 drops)well mixed buffer onto the sample well. 3. Read results within 10 minutes. INTERPRETATION OF RESULTS Negative: Only one
pink band appears on test region of the Cassette. Positive: Two pink bands appear on test
region of the Cassette. Invalid: If without colored band appears
on test region, PRECAUTION: 1、Must use fresh specimen and avoid freezing specimen repetitive 2、The result will be invalid 3、Use it before expiry 4、The package of kit should not be opened until it reaches the room temperature after taken from the refrigerator. 5、Old Serum can not be used. If the serum is thickness, it can be used only after being separated. LIMITED: 1、The test is only used for in-vitro diagnostic 2、The test is qualitative filter detection,it can not be used as the final test for blood donor or the patient of apparatus replant in HAV. It is just used for filter test.
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