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Breath ID BREATH TEST SYSTEM

Breath ID BREATH TEST SYSTEM

Breath ID BREATH TEST SYSTEM

Product catalog summary
Overview
The document discusses the use of 13C Urea Breath Testing as an advanced, non-invasive, and non-radioactive method for accurately detecting Helicobacter pylori (H. pylori) infection. It is suitable for both initial diagnosis and post-treatment follow-up.

Key Features
  • Fast: Results are available in 10 minutes, allowing for on-the-spot testing and treatment in a single visit.
  • Accurate: The test boasts over 99% sensitivity and specificity, validated by multiple studies and used in clinical trials.
  • Easy to Use: The test is CLIA non-regulated, requires no special license, and can be operated by any trained staff member with simple, one-button operation.

Clinical Relevance
  • H. pylori infection is associated with symptoms such as dyspepsia, GERD-like symptoms, gastric inflammation, and ulcers.
  • The test helps in ruling in or out infections, prescribing appropriate therapy, and reducing unnecessary antibiotic use.
  • It is recommended for confirming eradication post-treatment, especially after first-line triple therapy, which is effective in 80% of cases.

Recommendations
  • The AAFP and ACG recommend a test-and-treat strategy for patients under 55 based on symptoms.
  • Urea Breath Testing is preferred over blood antibody testing for confirming eradication, as serology tests have limited diagnostic value.

Economic Considerations
  • The Urea Breath Test offers enhanced revenue potential for practices, with estimated net profit per patient ranging from $45 to $55 based on Medicare rates.

References
  • Guidelines and data from various sources, including the American College of Gastroenterology and the Centers for Disease Control, support the use of Urea Breath Testing.
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Catalog excerpts

Breath ID BREATH TEST SYSTEM-1

Advanced Technology for Accurate Detection of H. pylori Infection Non-invasive, non-radioactive 13 C Urea Breath Testing

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Breath ID BREATH TEST SYSTEM-2

For initial diagnosis and post-treatment follow-up of Helicobacter Pylori infection FAST • 10 minutes from start to results • Enables on-the-spot testing (patients presenting with symptoms) • Test & treat in a single visit Urea Breath Testing “Identifies active infection. Excellent PPV and NPV. Useful before and after H. pylori therapy.” - ACG 2007 Guidelines1 >99% Sensitivity & Specificity2 ~150 exhalations included in analysis Validated in multiple studies published in peer-reviewed journals Used in numerous pharmaceutical and academic clinical trials CLIA non-regulated (no CLIA license required)...

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Breath ID BREATH TEST SYSTEM-3

Patients with common symptoms & major conditions may have an H. pylori infection 3 • Dyspepsia • Symptoms similar to GERD, IBS and other bowel & digestive conditions • Gastric inflammation • Peptic and gastric ulcers TEST then TREAT • • • • Definitively rule-in / rule-out infection Appropriately prescribe therapy Reduce the unnecessary use of antibiotics Prevent advanced conditions from occurring (H. pylori-related ulcers, cancer) AAFP and ACG recommend a test-and-treat strategy: Testing patients < age 55, based on symptoms (including undifferentiated dyspepsia).1,4 CONFIRM ERADICATION • First-line...

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Breath ID BREATH TEST SYSTEM-4

The Breath Test is the best test for the non-invasive detection of active H. pylori infection Blood Antibody Tests have limited diagnostic value “A positive (H. pylori serology) test is no better than a coin toss in predicting the presence of active infection.” (ACG Guidelines, 2007) 1 “Serology based office tests have no current role in the management of H. pylori infection.” (The Maastricht Consensus Report, 2002) 6 Urea Breath Testing is the only non-invasive test for H. pylori that offers enhanced revenue potential for your practice H. pylori Test Blood Antibody Stool Antigen BreathID Urea...

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