August 10, 2020

In-Depth Case Study on Helicobacter Pylori (H. Pylori) Non-Invasive Testing

Helicobacter pylori infection affects more than half of the world’s population. The infection is generally acquired during childhood but can remain asymptomatic, with long-term clinical sequelae including gastritis, peptic ulcer disease, and stomach cancer. 

Typically, non-invasive testing is the first method for the diagnosis of Helicobacter pylori (HP) infection. Among these, serological tests, stool antigen research and urea breath test are the most commonly used. Anti-HP is not recommended in low prevalence populations, other than that they may not reveal an ongoing infection, but they only prove contact with the bacterium. Furthermore, they may persist long after eradication of infection; therefore, they should not be used to verify the success of eradication therapy. Stool antigen research and urea breast test (UBT) are useful both in diagnosis and in follow-up after elimination treatment. The stool antigen test is cheaper than the urea breathing test with similar sensitivity and specificity. Non-invasive tests are not able to diagnose complications related to HP infection.

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According to MEDLINE and EMBASE databases and United Nations, in 2015, Africa had the highest pooled prevalence of H pylori infection (70.1%), whereas Oceania had the lowest prevalence (24.4%). Among individual countries, In Switzerland, the prevalence of H pylori infection varied from as low as 18.9% to 87.7% in Nigeria. Based on regional prevalence estimates, there were approximately 4.4 billion individuals with Helicobacter pylori infection worldwide in 2015.

Helicobacter pylori (HP) is a highly motile, spiral or curved rod-shaped gram-negative bacterium, with multiple flagella, which reside in the gastric mucosa-coated lining and gastric pits of the epithelial tissue of the stomach and / or duodenum. . Typically, HP colonizes the human stomach during childhood (1) and survives in the human stomach for the lifetime of the carrier (2). HP infection can be asymptomatic in most individuals, causing chronic gastritis. About 20 to 30% of infected persons may develop peptic ulcer disease, (3) and less than 2% may develop gastric cancer (4). Therefore, testing for HP infection has become a very important part of the diagnostic process for gastric and duodenal diseases, as the presence or absence of infection determines the type of treatment to be applied. The test is also useful for monitoring the effectiveness of anti-microbial treatments.

Also, according to World health Organization (WHO), 90% high prevalence rate has been observed in developing countries, whereas in developed countries the prevalence rate is low, i.e. 50%. The global Helicobacter pylori infection rate in female was found to be 42.7% as compared to 46.3% in males. Moreover, in adult it was significantly higher as compared to children, 48.6% and 32.6% respectively.

Globally, different conferences and events are held to make people aware about infections and give overview of how important is appropriate screening, early diagnosis of Helicobacter pylori infection and its effective cutting-edge treatment in successful eradication of the infection. Participants in these conferences/events can utilize these learnings to develop a framework for introducing Helicobacter pylori testing devices for their family practice and in healthcare facilities.

Several different invasive and non-invasive diagnostic methods are currently available (1–3). Invasive tests include histological examination and culture of biopsy specimens. These tests are considered highly specialized, especially histological examination, but its sensitivity depends partly on the accuracy of the biopsy procedure. In addition, both histological examination and culture of biopsy specimens are time-consuming and require specialized laboratory facilities with highly trained staff. For these reasons, several techniques have been developed and widely used for HP non-invasive clinical trials. They belong to three main categories:

In February 2019, MENA Conference held the Helicobacter pylori Update Conference in Abu Dhabi. The Emerging therapeutic areas such as the intestinal microbiome and the use of adjunctive therapies such as probiotics, importance of appropriate screening, early diagnosis, importance of antibiotic resistance rates, patient medical compliance with treatment and follow up with doctors were the major topics covered in this conference.

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Similarly, in January 2019, World Academy of Science, Engineering and Technology (WASET) organized the International Conference on Helicobacter pylori Treatment (ICHPT) in Amsterdam, The Netherlands, with the focus on bringing together leading academic scientists, researchers and research scholars to exchange & share their experiences and research results on aspects of Helicobacter pylori Treatment. Moreover, the upcoming the 20th Campylobacter, Helicobacter and Related Microorganisms(CHRO) conference is likely to be held in September 2019 in Ireland, providing presentations by local and international experts reporting their most recent scientific updates. This conference will provide the opportunity to meet, listen to and interact with world class experts in areas of scientific and clinical research, public health and industry.

The List of Companies Operating in this Study:

1. DiaSorin S.p.A.
2. Meridian Bioscience
3. Exalenz Bioscience Ltd.
4. Abbott
5. Thermo Fisher Scientific, Inc
6. Certest Biotec S.L.
7. Sekisui Diagnostics (Sekisui Chemical Co. Ltd.)
8. CorisBioconcept SPRL
9. Shenzhen Zhonghe Headway Bio-Sci & Tech Co., Ltd.
10. Bio-Rad Laboratories, Inc.