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Urea
Breath Test Advantages |
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Diagnose H. pylori, Treat and Confirm Eradication
Active H. pylori
detection avoids unnecessary treatment
- Empiric therapy with antibiotics does not confirm
infection and can contribute to antibiotic resistance
- Serology cannot distinguish between active and
recent infection and is 18 times more likely to lead
to unnecessary treatment (1)
Confirmation of cure with the Urea
Breath Test (BreathTek™)
- FDA cleared to confirm cure
- Offers doctor and patient peace of mind by ensuring
that infection has been eradicated
- Allows for a follow-up visit for optimized patient
management
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Performance Characteristics
of H. pylori Tests
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Urea Breath Test (BreathTekTM) compared
to other H. pylori tests
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| Serology |
Urea
Breath Test (BreathTekTM) |
Requires drawing blood
|
Painless |
Not approved to test for cure
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FDA cleared to test for cure |
Low sensitivity/specificity (4)
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High sensitivity/specificity (2) |
Detects H. pylori antibodies
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Detects active H. pylori infection
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C14 Urea
Breath Test
|
Urea Breath
Test (BreathTekTM) |
| Uses a radioactive ingredient; requires
special handling |
No special handling required |
| Not approved to test for cure |
FDA cleared to test for cure |
| Endoscopy
|
Urea Breath
Test (BreathTekTM) |
| Invasive |
Non-invasive |
| Time consuming and uncomfortable |
Quick and painless |
Time consuming and uncomfortable
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Quick and painless |
| Stool Antigen
Test |
Urea Breath
Test (BreathTekTM) |
| Special storage and shipping requirements
for patient |
Minimal inconvenience for patient |
| Stool is a biohazardous material |
No biohazardous component |
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- Chey WD, Abrahamse PH, Fendrick MA. Active or antibody
testing to diagnose H. pylori infection? Examining
the clinical and economic tradeoffs using decision
analysis (abstract). Gastroenterology. 2000;118, No.
4, Suppl. 2: A2699.
- Data on file.
- Graham KS, Graham DY. Contemporary Diagnosis and
Management of H. Pylori-Associated Gastrointestinal
Diseases. Newtown, PA: Handbooks in Health Care Co;
2002.
- Medical Device Agency Evaluation Report, number
MDA/97/55.
- PYtest package insert. Tri-Med Specialties Inc.
- Vaira D, Vakil N. Blood, urine, stool, breath,
money, and Helicobacter pylori. Gut. 2001;48:287-289.
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Metabolic Solutions, Inc., 460 Amherst
Street, Nashua, NH 03063
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