Introduction   

The function parts of the test kit are diluting liquid and test cards which contain immunological reagent on the chromatographic membrane. The stationary reagent line that has been applied onto the membrane in the test area (T) is otherwise invisible, but if the sample passes through membrane contains HP antigen to the specific HP antibody, the line turns distinctly red in the test area. The control line that has been put on the membrane in the control area (C) invisible before the test turns red during the assay process, thus indicates proper performance of the test device. Regardless of the existence of HP antigen in the sample, the control line will appear.

  Specimen collection  

Stool can be used as the sample for this test kit. Samples shall be stored refrigerated(2℃-8℃) for two days,also can be frozen(-20℃)for long-term storage,but avoid repeated freezing and thawing. Fresh sample is recommended.

  Test procedure  

1. Before using the kit,you must read this introduction,and make sure that the kit and samples were returned to room temperature.

2. Open the bottle which has extracting liquid, take one of the mung bean size (about φ 5 mm) of the stool sample using with the stick on the cap, then put it into extracting liquid and turn off the cap. Squeeze and shake the bottle hard for 2 minutes.

3. Take out one test card and make sure it should be used within an hour. The card should be put on the clean, dry, flat test stand. Break off the top of the cap. You just need to drop 2-3 drops sample extracting liquid in the sample hole (S).

4. Read the result in 15 minutes. The result is not acceptable 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 HP- antigen- in the stool.

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

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.

  Limitation  

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

2.Ideal test results should fully comply with the above testing procedures. Operation error may lead to incorrect results.

3.The test kit is for in vitro diagnostic use and the detection of antigen in stool samples only,the result is just a qualitative analysis , not a quantitative detection.

4.A positive result or a negative result just show that the antigen activity of the sample is above or below the cut-off level of the test,the result can not be used as the sole criterion of HP infection. If necessary,other methods or equipment are needed,Professionals should according to the further test results and clinical symptoms to make judgments.