H.pylori Antibody Whole Blood Test Cassette

H.pylori Antibody Test Cassette is a rapid chromatographic immunoassay for the qualitative detection of antibodies to H.pylori in whole blood, serum or plasma to aid in the diagnosis of H.pylori infection.

Features

• Quick result read in 15 minutes
• High accuracy over 99%
• Sensitivity 97.3%

Packaging

Box of 25T, Ctn of 1000T

One Step H.Pylori Antibody Whole Blood Test Cassette

INTRODUCTION

One Step H.Pylori Antibody Test is a lateral flow, immunochromatographic screening test. Recombinant antigen of HP are used in test band as capture materials and gold conjugates. If the antibody of HP is present in the sample in concentration above the labeled ,complex will be formed. This complex is then captured by antigens 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 the anti-HP present in the sample. This one step test is very sensitive and only takes about 15-20 minutes. Test results are read visually without any instrument.

SPECIMEN COLLECTION

For whole blood, collect blood into a container with anticoagulant (EDTA or heparin ).

Use the specimen inside an hour. If the specimen can not be tested inside an hour, store the specimen in 4℃ cold closet or refrigerator, but Don’t freeze. Bring the specimens to room temperature before testing. Do not freeze and thaw the specimen repeatedly.

TEST PROCEDURE

1. Open a pouch containing a cassette, lay the cassette.
2. Using the plastic pipettor provided, draw one drop of whole blood into the sample well of the cassette.
3. Then draw one drop of buffer into the sample well.
4. Read results within 10-15 minutes. Do not read results after 20 minutes.

INTERPRETATION OF RESULTS

Negative: Only one band appears on test region of the Cassette. This indicates that there is no detectable anti-HP in the serum.

Positive: Two bands appear on test region of the Cassette. This indicates that the specimen contains detectable amount of anti-HP.

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:

1. Must use fresh specimen and avoid repetitive freezing, the result will be invalid
2. Use it before expiry date.
3. The package of kit should not be opened until it reaches the room temperature if it taken out from the refrigerator.

LIMITATIONS

• The test is for in-vitro diagnostic use only.
• The test is qualitative filter detection，it can not be used as the final test for blood donor

STORAGE AND STABILITY

The test kit can be stored at room temperature (2 to 30°C) in the sealed pouch to the date of expiration. The test kit should be kept away from direct sunlight, moisture and heat.