Information about the Helicobacter pylori test Pylori-Screen
H. pylori test is a certified diagnostic medical device for testing at home.
The test is a blood test that enables you to screen the infection with Helicobacter pylori by detecting the presence of specific antibodies against the bacteria Helicobacter pylori in whole blood.
Testing with this Helicobacter pylori test is straightforward. You carry out the analysis in three steps:
- withdraw blood from a fingertip,
- add the blood and buffer to the testing device,
- wait 10 minutes for the result.
Individuals usually need 5-10 minutes to complete the H. pylori test at home. Above that, there is an additional 10-minute waiting time for the result to appear.
The test is manufactured in France and is ISO13485 compliant and CE certified by Notification body 04831. The test is very accurate. In clinical trials, the H. pylori test showed a correct result in 94,1% cases.
Moreover, in the last few years, tens of thousands Helicobacter pylori home tests have been performed all over the world, which demonstrates the usability and reliability of the test for screening the H. pylori infection.
The H. pylori test also comes with the Sanotest Quality Guarantee and will be replaced to you free of charge in case you were not able to obtain the result.
You will receive the Helicobacter pylori test in discreet packaging so that nobody will know what is inside the package.
Testing kit includes everything you need to perform testing for Helicobacter pylori infection at home. The kit comes with easy-to-follow instructions for use.
About the bacteria Helicobacter pylori
Bacteria Helicobacter pylori are a class 1 carcinogen by the World Health Organisation.2
Bacteria Helicobacter pylori infect the stomach. It can cause the atrophy of the gastric mucosa which weakness the protective stomach lining and induces chronic inflammation. This leads to the formation of stomach ulcers.
Infection with H. pylori is the most common infection in the world, with more than 50% world’s population infected.
At 10-15% of infected, bacteria will cause peptic ulcers, and approximately 1% will develop gastric cancer.
When to get tested for H. pylori infection?
The infection with H. pylori is often acquired during childhood and lasts for decades.3 Scientific research shows that transmission of bacteria depends on person to person contact, and it happens mostly within families and local communities.4
If your family member, partner, close friend, a colleague at work or other you are often in touch with is infected or has been infected in the past, it could be beneficial for you to get tested for H. pylori.
Symptoms of H. pylori infection
Individuals infected with H. pylori mostly do not have any symptoms of infection, and most infected individuals do not develop some apparent disease.5
Experts, therefore, recommend testing for H. pylori infection, especially to individuals with symptoms of infection.6 Common symptoms are:
• burning pain in the abdomen,
• loss of appetite,
• unexplained weight loss,
• black stool with an odor of iron,
• blood in the stool.
Benefits of testing for H. pylori at home?
Testing for Helicobacter pylori at home is a convenient, time and cost-efficient approach for screening an infection.
Helicobacter pylori infection can be detected using several scientifically proven and medically approved techniques.
An invasive technique, commonly used in clinical practice is a biopsy of the gastric mucosa. Non-invasive methods are serology testing, stool antigen testing and urea breath tests, performed by medical laboratories.
This H. pylori home test is a serology test that detects specific antibodies against H. pylori in whole blood. Its results highly correlate with results obtained in a laboratory.
The main reason why people decide to perform the Helicobacter pylori test at home is that they want to identify the cause of their stomach problems or check if the reason could be infection with Helicobacter pylori.
Since H. pylori cause peptic ulcers and H. pylori infection is the most common infection in the world, it is worth to check if the cause of stomach problems is bacteria Helicobacter pylori.
How accurate is the H. pylori home test?
The test is 94,1 % accurate as it has been evaluated in performance evaluation studies.
Using the same samples, results obtained with these H. pylori home tests have been compared to results obtained in a laboratory against three different methods – ELISA, Western Blot, and Biopsy cell culture.
We would like to point out that this test is one of the rare home tests available on the market with an accuracy evaluated against three different laboratory methods.
The test is manufactured in France, it is ISO134857 compliant and CE certified in Germany by Notification body 04838.
How to perform the H. pylori test at home?
A unique design of the H. pylori test enables individuals with no knowledge or experience in medical self-testing to carry out the analysis easily by themselves at home.
The testing kit comes with easy-to-follow instructions for use that guide you through the testing procedure.
Individuals usually need 5-10 minutes to carry out the H. Pylori test at home. Above that, there an additional 10-minute waiting time for the result to appear.
The H. pylori test is a serology test. A small sample of blood from a fingertip needs to be collected (accessories for blood collection come with the kit).
There are three general steps you need to follow to carry out the test successfully:
- withdraw blood from a fingertip,
- add the blood and buffer to the testing device,
- wait 10 minutes for the result to appear.
You should read instructions for use before you start the testing procedure. Individuals usually do not have difficulties using the test, but in case you find it difficult, we are here to help you. Contact our customer service.
The usefulness of the results obtained with the Helicobacter pylori home test
Results obtained with this H. pylori home test are especially useful as an early sign of an infection with the bacteria Helicobacter pylori.
Results are interpreted visually as positive, negative or invalid.
In case of a positive result: you should consult your doctor who will decide about further steps.
In case of a negative result: monitor the symptoms of an infection, and perform another test if necessary. If symptoms persist, you should consult your doctor for further investigation.
In case of an invalid result: the Sanotest Quality Guarantee applies. Please contact us.
Limitations of the H. pylori home test
With many advantages of the H. pylori home test, there are also some limitations you should consider before ordering the test. In the end, H. pylori home test should serve your needs and your satisfaction matters the most.
The test cannot distinguish between current and past infection.
The test detects specific antibodies against Helicobacter pylori in whole blood. These antibodies can stay in the blood for several years after successfully treated infection.9 Therefore it is not relevant to use this test if you have been recently diagnosed for H. pylori infection.
The test is not suitable to follow-up H. pylori eradication treatment.
If you need to check if H. pylori eradication treatment was successful, then this test is not suitable for you. We recommend you to consult your doctor or visit a laboratory to perform testing that is suitable for a treatment follow-up.
You should not establish a diagnosis on your own and solely based on this H. pylori home test.
Although the test is highly accurate, you should not establish a diagnosis and conclusions about the treatment solely based on the result of this H. pylori test. You should always consult your doctor for further investigation, diagnosis, and potential treatment of H. pylori infection.
The H. pylori test is for single use and one person only.
You should never combine blood samples or reuse the test. Only one person should use the H. pylori test. Once the analysis is complete, you cannot reuse it.
Questions and answers about the H. pylori home test
In the following are summarized questions individuals frequently ask us about the H. pylori home test. Perhaps you find the answers useful.
If you have other questions, do not hesitate to contact us. Please send us your question by email to firstname.lastname@example.org.
What is the principle of the H. pylori home test?
The H. pylori test is a serology test that detects specific antibodies against the bacteria Helicobacter pylori in whole blood. When an individual gets infected, the body’s immune system responds in a way that produces specific antibodies to eliminate the bacteria. These antibodies are circulating in the blood. The test detects these antibodies explicitly, and in case they are present in the blood sample, the test will show a positive result.
Do all individuals develop specific antibodies against H. pylori?
Not all, but scientific literature states that the majority of people develop specific antibodies against H. pylori.10
How do you know that a testing device works correctly?
A testing device has integrated internal control. When a colour line appears in the control area of a testing device, it means that a testing device works correctly.
Is it possible that the test shows an incorrect result?
Yes, it is possible. As with all diagnostic techniques, there is a certain probability that the result is incorrect. If you carefully follow instructions for use, the overall likelihood of a false result is 5,9 % as demonstrated in performance evaluation studies against three different diagnostic techniques.
Will a doctor take into consideration the result of H. pylori home test?
As our customers report us, their doctors take into consideration the results of H. pylori home test. Furthermore, doctors usually decide to evaluate the infection in more depth and act accordingly.
Do I need to stop taking PPI medications (proton pump inhibitors) before performing the H. pylori home test?
No, you do not need to stop taking PPI medications before performing the H. pylori home test. Specific antibodies against Helicobacter pylori can also be detected in case of ongoing therapy with PPI medications.11
Do I need to undergo some special diet before performing the H. pylori home test?
No, you do not need to undergo any special diet before performing the H. pylori home test.
Can children get tested for H. pylori?
The H. pylori test can also be used to test children, but the testing should be carried out only by adults. Nevertheless, in case a child needs to get tested for H. pylori infection, we recommend you consult a doctor.
Are blood collection accessories included in the testing kit?
Yes, they are. You receive everything you need to perform the H. pylori test at home.
1 European Commission. Tools and Databases, Legislation. Accessible at: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.nb&refe_cd=EPOS_43805 (10. 03. 2020).
2 World Health Organisation, 1994. International agency for research on cancer. IARC Monographs on the evaluation of carcinogenic risks to humans. Volume 61. Accesible at: https://monographs.iarc.fr/wp-content/uploads/2018/06/mono61.pdf (10. 03. 2020).
3 Correa P, Piazuelo BM 2008. Natural history of Helicobacter pylori infection. Digestive and liver disease: official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver. 2008;40(7), 490-496.
4 Schwarz S, Morelli G, Kusecek B, Manica A, Balloux F, Owen RJ, Graham DY, van der Merwe S, Achtman M, Suerbaum. Horizontal versus familial transmission of Helicobacter pylori. S PLoS Pathog. 2008 Oct; 4(10):e1000180.
5 Testerman, T. L., & Morris, J. (2014). Beyond the stomach: an updated view of Helicobacter pylori pathogenesis, diagnosis, and treatment. World journal of gastroenterology, 20(36), 12781–12808.
6 Malfertheiner P, Megraud F, O’Morain CA on behalf of the European Helicobacter and Microbiota Study Group and Consensus panel, et al. Management of Helicobacter pylori infection—the Maastricht V/Florence Consensus Report. Gut 2017;66:6-30.
7 International Organization for Standardization. ISO 13485:2016, Medical devices — Quality management systems — Requirements for regulatory purposes. Accessible at: https://www.iso.org/standard/59752.html (10. 03. 2020).
8 European Commission. Tools and Databases, Legislation. Accessible at: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.nb&refe_cd=EPOS_43805 (10. 03. 2020).
9 Miernyk, K. M., Bruden, D. L., Bruce, M. G., McMahon, B. J., Hennessy, T. W., Peters, H. V., Hurlburt, D. A., Sacco, F., & Parkinson, A. J. (2007). Dynamics of Helicobacter pylori-specific immunoglobulin G for 2 years after successful eradication of Helicobacter pylori infection in an American Indian and Alaska Native population. Clinical and vaccine immunology : CVI, 14(1), 85–86.
10 Lina, T. T., Alzahrani, S., Gonzalez, J., Pinchuk, I. V., Beswick, E. J., & Reyes, V. E. (2014). Immune evasion strategies used by Helicobacter pylori. World journal of gastroenterology, 20(36), 12753–12766.
11 Enko, Dietmar & Halwachs-Baumann, Gabriele & Stolba, Robert & Rössler, Ortrun & Kriegshäuser, Gernot. (2016). Performance evaluation of a rapid whole-blood immunoassay for the detection of IgG antibodies against Helicobacter pylori in daily clinical practice. Annals of Clinical Microbiology and Antimicrobials. 15. 10.1186/s12941-016-0161-1.