Intended Use
H. Pylori Antigen Rapid Test Kit (Lateral chromatography) is to be used for in vitro qualitative diagnostic of helicobacter pylori antigen in human feces. The test is only to be used by medical professionals.
Test Principle
The kit is immunochromatographic and uses double-antibody sandwich method to detect H. Pylori Antigen. It contains Colored spherical particles labeled H. Pylori monoclonal antibody that is wrapped in conjugate pad. Another H. Pylori monoclonal antibody that is fixed on the NC membrane. and quality-control line C that is coated with goat anti mouse IgG antibody, adopt the highly specific antigen-antibody reaction and lateral chromatography technology, qualitatively determine H. Pylori Antigen levels in human feces.
Component/REF | B012C-01 | B012C-25 |
Test Cassette | 1 test | 25 tests |
Sample Diluent | 1 bottle | 25 bottles |
Instructions for use | 1 piece | 1 pcs |
Certificate of conformity | 1 piece | 1 piece |
Step 1: Sampling
Collect fecalspecimensin clean, leak-proof containers.
Step 2: Testing
1.Remove a test cassette from the foil pouch and place on a flat surface
2.Unscrew the sample bottle, use the attached applicator stick attached on the cap to transfer small piece of stool sample (3-5 mm in diameter; approximately 30-50 mg) into the sample bottle containing specimen preparation buffer.
3.Replace the stick into the bottle and tighten securely. Mix stool sample with the buffer thoroughly by shaking the bottle for several times and leave the tube alone for 2 minutes.
4. Uncrew the sample bottle tip and hold the bottle in a vertical position over the sample well of the Cassette, deliver 3 drops (about 100 -120μL) of diluted stool sample to the sample well.
Step 3: Reading
15 mins later, read the results visually. (Note: do NOT read the results after 20 mins!)
1. Negative result
If only the quality control line C appears and the detection lines G and M do not show, it means that no novel coronavirus antibody is detected and the result is negative.
2. Positive Result
2.1 If both the quality control line C and the detection line M appear, it means that the novel coronavirus IgM antibody is detected, and the result is positive for the IgM antibody.
2.2 If both the quality control line C and the detection line G appear, it means that the novel coronavirus IgG antibody is detected and the result is positive for the IgG antibody.
2.3 If both the quality control line C and the detection lines G and M appear, it means that the novel coronavirus IgG and IgM antibodies are detected, and the result is positive for both IgG and IgM antibodies.
3. Invalid Result
If the quality control line C cannot be observed, results will be invalid regardless of whether a test line shows, and the test should be repeated.
Product Name | Cat. No | Size | Specimen | Shelf Life | Trans. & Sto. Temp. |
H. Pylori Antigen Rapid test kit (Lateral chromatography) | B012C-01 | 1test/kit | Feces | 18 Months | 2-30℃ / 36-86℉ |
B012C-25 | 25 tests/kit |