Home test for the detection of Helicobacter pylori infection

Contents of Package

• Foil Package (Contains: Test Device and Dropper)
• Vial of Test Solution
• Finger Stick Device
• Alcohol Swab

Questions and Answers

What is H.pylori?
Helicobacter pylori (H.pylori) is a bacteria that infects your stomach and may cause gastritis and stomach ulcers.
How does this test work?
This test detects antibodies produced in your body in response to the H.pylori infection. If the antibodies are present, the test gives a positive result. The test is designed to demonstrate the presence of antibodies to H.pylori bacteria in blood.
What is the clinical performance of Diago-HP?
Clinical studies for Diago-HP were performed using 186 samples with confirmed positive or negative results (results were confirmed by ELISA). Diago-HP showed relative accuracy of 98.2%, relative specificity of 100.0%, and relative sensitivity of 96.2%.
What do I do if the test indicates a positive result?
This test is meant only as a screen. If you get a positive result, call your doctor and discuss the result.
How long do I have to wait to read the results?
The test results must be read at 15 minutes after adding the Test Solution. The results are not valid if they are read after 15 minutes.
What if the lines in the Results Window are not the same color or intensity?
The color or intensity of the lines in the Results Window do not have any significance. If the lines are visible and
unbroken then they can be interpreted as explained above.
What is the purpose of the line in the Control Area?
The line in the Control Area assures you that the test was run correctly. If no line appears in the Control Area then the test is invalid and should be repeated.