One step HP Test Kits Test Card

One step HP Test Kits Test Card

INTRODUCTION

One Step ANTI-HP Rapid Screen Test is a lateral flow, immunochromatographic screening test. Purified recombinant antigens of HP are precoated onto membrane as a capture reagent on the test band region.If the antibody of HP is present in the sample in concentration above the labeled anti-human IgG-dye 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 serum, collect blood into a container without anticoagulant. If the specimen cannot be tested on the day of collection, store the serum specimen in a refrigerator or freezer. Bring the specimens to room temperature before testing.

TEST PROCEDURE

1. Open a pouch containing a cassette, lay the cassette.

2. Using the plastic pipettor provided, draw two or three drops of sample into the sample well of the cassette.

3.Read results within 10-15 minutes. Do not read results after 20 minutes.

INTERPRETATION OF RESULTS

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

Positive: Two pink 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.

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

LIMITATIONS

1,The test is for in-vitro diagnostic use only.

2,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.