BIONEXIA® H. pylori Ag

Cost-effective and non-invasive detection of H. pylori antigen in stool samples

BIONEXIA® H. pylori Ag is a rapid stool antigen test that concentrates in a small cassette all of bioMérieux’s expertise in microbiology. It provides a quick first-line answer for optimal patient management.

  • Non-invasive method
  • Simple, user-friendly process
  • Result available after only 10 minutes
  • State-of-the-art performances

 

 

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Helicobacter pylori (H. pylori) is a microorganism that colonizes the stomach in about 50% of all humans(1), leading to chronic gastritis. Among the patients colonized by H. pylori, 1-10% will develop a gastric or duodenal ulcer, and 0.3 – 3% will develop a stomach cancer(2). H. pylori is now recognized as the first microorganism involved in cancer.

BIONEXIA® H. pylori Ag test detects Helicobacter pylori antigen in human stool specimens (adult and children). It is an accurate aid for the diagnosis of active H. pylori infection for patients presenting with symptoms of gastritis and/or ulcers, and to confirm H. pylori eradication after treatment(3).

Ease of use for universal practice

A simple process for results in just 10 minutes:

1 - Collect and extract stool sample:

H. Pylory detection - Step 1

2 - Apply 4 drops of sample into the cassette sample well, and read the result between 10 and 15 minutes later:

H. Pylory detection - Step 2     H. Pylory detection - Step 3

 

  • Applicable for use in laboratories and for near-patient testing as part of a medical consultation

A key element of the Test-and-Treat Strategy

The test-and-treat strategy involves a non-invasive test for H. pylori and immediate treatment of the infection when positive. Within a certain population, it can avoid endoscopies and then avoid risk, cost and patient discomfort.
 

Diagnostic algorithm:


Click to enlarge 

* GERD : gastroesophageal reflux disease ** according to Maastrich IV, age cut-off point depends on local incidence of gastric cancer in different age groups *** PPI: proton pump inhibitor

Adapted from

AGA Board: Evaluation of Dyspepsia, Nov 2005: 1753-1755. - Chey WD, et. al.,, Am J Gastroenterol, Aug 2007;102: 1808-1825 

A test-and-treat strategy using a non-invasive test such as a stool antigen test is appropriate for uninvestigated dyspepsia in populations where the H. pylori prevalence is over 20% (3).

Using stool antigen testing with repeat testing after treatment is the most cost-effective approach(4). For every 1000 people managed under this strategy (assuming 75% prevalence), experts expect that 3.0 gastric cancers and 22.8 ulcers should be prevented(4).

Stool antigen tests have been shown to significantly lower the overall costs of screening, especially in populations with high prevalence of H. pylori(5).

A complete offer for H. pylori testing

bioMérieux offers a complete offer for H. pylori testing:

 
Product name
Reference
Detection after 10 minutes of Helicobacter pylori antigen in stool samples
BIONEXIA® H. pylori
415 669

Detection after 40 minutes of anti-H. pylori IgG in serum and plasma

30 192
Transport media for biopsy samples
PORTAGERMTM pylori
42 041
Culture of H. pylori from biopsy samples
413 193
Identification of H. pylori
20 800
Susceptibility testing of H. pylori
412 313
412 243
412 393
412 404
412 471

References:

1. Rizwan et al; Epidemiology and pattern of antibiotic resistance in Helicobacter pylori: scenario from Saudi Arabia. Saudi J Gastroenterol. 2014 Jul-Aug;20(4):212-8. doi: 10.4103/1319-3767.136935.

2. McColl K. N Engl J Med. 2010;362(17):1597-1604

3. Malfertheiner P. et al. Gut. 2012;61:646-664

4. Using Stool Antigen to Screen for Helicobacter pylori in Immigrants and Refugees from High Prevalence Countries Is Relatively Cost Effective in Reducing the Burden of Gastric Cancer and Peptic Ulceration: Schulz TR et al - www.plosone.org - September 2014 | Volume 9 | Issue 9 | e108610

5. Schulz T. et al. PLOS ONE. 2014;(9):e108610

  BIONEXIA® H. pylori Ag
 

Rapid stool antigen test

Reference 415 669
Content of the kit
  • 25 individually sealed pouches each containing a test cassette and a desiccant
  • 25 stool collection tubes
  • 1 quick user guide printed on the box
  • 1 package insert
Sample type Stool
Sample volume 180 μL ± 30 μL

Performance versus ELISA microplate assay*

Positive percent agreement: 
94.1% [87.0 ; 97.5] %

Negative percent agreement:
95.5% [89.8 ; 98.5] %

Overall percent agreement:
94.9% [90.9 ; 97.2] %

Time to result 10 minutes
The test result is stable for 5 minutes.
Storage temperature 2 – 30°C
Shelf life 24 months from date of manufacturing

 

* See package insert for further details.

 

Kits are for use by healthcare professionals in laboratories and for near-patient testing as part of medical consultations.

Consult your local bioMérieux representative for product availability in your country.

RELATED PUBLICATIONS

Briand H, et al. Rapid detection of H. pylori Ag in human stool with the new BIONEXIA® H. pylori Ag test

Poster presented at the EHMSG congress, Nicosia (Cyprus), September 2015.

INTERNATIONAL GUIDELINES

  • Europe:
    Management of Helicobacter pylori infection The Maastricht IV/ Florence Consensus Report, gut.bmj.com on April 12, 2012
     
  • North America:
    American College of Gastroenterology Guideline on the Management of Helicobacter pylori Infection Chey et al; Am J Gastroenterol 2007;102:1808–1825)
     
  • Latin America:
    Management of Helicobacter pylori infection in Latin America: A Delphi technique-based consensus; Rollan et al; World J Gastroenterol 2014 August 21; 20(31): 10969-10983
     
  • Asia-Pacific:
    Second Asia–Pacific Consensus Guidelines for H. pylori, KM Fock et al., Journal of Gastroenterology and Hepatology 24 (2009) 1587–1600

USEFUL LINKS

Site of the European Helicobacter and Microbiota Study Group - EHMSG

http://www.helicobacter.org/

Please consult your local bioMérieux representative for product availability in your country

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