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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 buffer1:1000,  then drop 75ul3 dropswell 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.
This indicates that there is no detectable HAV antibody in the serum.

Positive: Two pink bands appear on test region of the Cassette.
This indicates that the specimen contains detectable amount of HAV antibody.

Invalid: If without colored band appears on test region,
this is an indication of a possible error in performing the test.
The test should be repeated using a new device.

PRECAUTION:

1Must use fresh specimen and avoid freezing specimen repetitive 

2The result will be invalid

3Use it before expiry

4The package of kit should not be opened until it reaches the room temperature after taken from the refrigerator.

5Old Serum can not be used. If the serum is thickness, it can be used only after being separated.

LIMITED:

1The test is only used for in-vitro diagnostic

2The test is qualitative filter detectionit 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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Last modified: 05/29/09