H.Pylori Antigen Rapid Test Kit

Intended Use

H.Pylori Antigen Rapid Test is a rapid immunochromatographic assay for the qualitative detection of Helicobacter Pylori antigen in feces samples. It is intended to be used as an aid in the diagnosis of Helicobacter Pylori infection and to monitor the effectiveness of therapeutic treatment and to confirm the eradication of H.pylori in peptic ulcer patients. The test is recommended for professional use only.

Test Procedure

Test device, patient’s samples, and controls should be brought to room temperature (15-30℃) prior to testing. Do not open pouches until ready to perform the assay.

1. Remove the test device from its foil pouch by tearing along the notch and use it as soon as possible.

2. Specimen collection. See also specimen collection.

3. Holding the sample collection device upright, carefully break off the tip of collection device.

4. Squeeze 2 drops (~80uL) of the sample solution in the sample well of the cassette. See the illustration.

5. Read the test results in 10 minutes. It is important that the background is clear before the result is read. Do not read results after 10 minutes. To avoid confusion, discard the test device after interpreting the result.

Interpretation of Result

(Please refer to the above illustration)

Negative: Only the C line appears, and no T line developed.

Positive: Both C and T lines appear, the result is positive.

The intensity of the test line (“T”) may be less than that of the control line (“C”); this still means positive result.

Samples with positive results should be confirmed with alternative testing method(s) and clinical findings before a positive determination is made.

Invalid: No C line appears, regardless the color of T line. The assay is invalid. Repeat the assay with a new device. If the problem persists, contact your local distributor.