Test yourself for Helicobacter pylori bacteria at home in peace and quiet with our fast, CE-marked self-test. With a simple stool sample, you get a reliable result in 10 minutes indicating whether your recurring stomach and intestinal issues (such as heartburn, gastritis, or stomach pain) may be caused by H. pylori. Sent in a completely neutral and discreetly packaged envelope directly to your mailbox.
How to perform the test in short
- Sampling: Collect the stool sample on the provided collection paper. Unscrew the cap of the collection tube and poke the sampling stick into 3 different places in the sample.
- Preparation: Insert the stick back into the collection tube, screw the cap tight, and shake vigorously to mix the sample with the dilution buffer. Let the tube stand for 2 minutes.
- Reading: Open the cap, turn the tube upside down, and transfer 2 full drops to the specimen well (S) on the test cassette. Read the result at 10 minutes. (Do not interpret the result after 20 minutes have passed).
Result interpretation & Important advice
- Positive result (Two colored lines C and T): H. pylori antigens have been detected in the stool. Important: The bacterium H. pylori is a common cause of gastritis and peptic ulcers. You should contact a doctor or healthcare center for further evaluation and potential treatment.
- Negative result (One colored line at C): No H. pylori antigens were detected in the sample. If you have persistent or worsening stomach symptoms, you should still consult a physician.
- Important limitations: The test only indicates the presence of H. pylori antigen and is not intended for the detection of stomach cancer. Following certain antibiotic treatments, bacterial levels may decrease below the test's detection limit.
Specifications & Product Information
CE-marked IVD product for self-testing by laypersons according to IVDR (EU) 2017/746
- Product name: Helicobacter Pylori Rapid Test (REF: IHP-N602H)
- Risk class (IVDR): Class C
- Intended purpose: Rapid test for the qualitative detection of H. pylori antigens in human stool specimens
- Results within: 10 minutes (do not interpret after 20 minutes)
- Sample type: Stool sample
- Performance characteristics:
- Diagnostic sensitivity: 98.4 %
- Diagnostic specificity: 100.0 %
- Overall accuracy: 99.1 %
- CE marking & Notified body: CE 0123
- Legal manufacturer: Hangzhou AllTest Biotech Co., Ltd., #550 Yinhai Street, Hangzhou, China
- EU Authorized Representative: MedNet EC-REP GmbH, Borkstrasse 10, 48163 Muenster, Germany
Package leaflet (PDF)