INTENDED USE
The H. pylori Antigen Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of Helicobacter pylori antigen in human stool specimen. . This kit is intended to be used as an aid in the diagnosis of H. pylori infection.
MATERIALS
Materials Provided
- Individually packed test devices
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- Specimens dilution tube with buffer
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TEST PROCEDURE
Bring tests, specimens, buffer and/or controls to room temperature (15-30°C) before use.
1. Specimen collection and pre-treatment:
1)Best results will be obtained if the assay is performed within 6 hours after collection.
2)Unscrew and remove the dilution tube applicator. Be careful not to spill or spatter solution from the tube. Collect specimens by inserting the applicator stick into at least 3 different sites of the feces to collect approximately 50 mg of feces (equivalent to 1/4 of a pea).
3)Place the applicator back into the tube and screw the cap tightly. Be careful not to break the tip of the dilution tube.
4)Shake the specimen collection tube vigorously to mix the specimen and the extraction buffer.
2. Testing
1)Remove the test from its sealed pouch, and place it on a clean, level surface. Label the test with patient or control identification. To obtain a best result, the assay should be performed within one hour.
2)Using a piece of tissue paper, break the tip of the dilution tube. Hold the tube vertically and dispense 2 drops of solution into the specimen well (S) of the test device.
3. Wait for the colored band(s) to appear. The result should be read at 10 minutes. Do not interpret the result after 20 minutes.
INTERPRETATION OF RESULTS

PERFORMANCE CHARACTERISTICS
Table: H. pylori Antigen Rapid Test vs. Endoscope-based Method
Method |
Endoscope-based Method |
Total Results |
H. pylori Antigen Rapid Test |
Results |
Positive |
Negative |
Positive |
131 |
0 |
131 |
Negative |
1 |
223 |
224 |
Total Result |
132 |
223 |
355 |
Relative Sensitivity: 99.24% (95%CI: 95.41%~>99.99%)
Relative Specificity: >99.9% (95%CI:99.96%~100%)
Accuracy: 99.72% (95%CI:98.26%~>99.99%)


