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• Epidemiology
• Most prevalent infection world
wide
• Commonly acquired during
childhood
– 10% by age 10
– 60% by age 60
• Low socioeconomic
• In U.S., more common in
Blacks/Hispanics
• Transmission Route
– Fecal-oral
– Oral-oral
Introduction
• Potential benefits
– Fewer upper GI endoscopies performed, particularly in pts 55 or younger
– Increase in number of noninvasive Hp tests performed
– Decrease in overall cost of managing dyspepsia
– Increase in number of patients w/ dyspepsia receiving effective treatment
• Noninvasive Test
– serology (ELISA)
– 13C or 14C urea breath test (UBT)
– stool antigen test
Usefullness of Noninvasive tests
• Research
• Pre-endoscopic screening of patients for
referral to a GI service for investigation of
dyspepsia
• Therapeutic monitoring following
eradication therapy to confirm elimination of
infection
H. Pylori testing
Serology
• Serology
– IgG, IgA, IgM
– Multiple antibodies provide higher sensitivity
than any single antibody
– only indicates infection, does not confirm if
active
– Unreliable indicator of H. pylori status in
patients who have received treatment
– Very Specific (few false-positive results)
H. Pylori testing
UBT
• Urea breath test
– gold standard for 1o diagnosis and monitoring of
eradication-has excellent sensitivity & specificity
– expensive instruments
– requires trained staff for air sampling
– time consuming
– requires use of isotopically labeled urea
– difficult for children and neurologically handicapped
patients
H. Pylori testing
HpSA
• Stool antigen enzyme immunoassay
• Based on detection of H. pylori stool antigen
– Polyclonal antigen tests
• older - lower sensitivity in comparison to UBT and
considerable inter-test variability
• antigenic composition could change from batch to batch
– Monoclonal antigen test
• EIA based on a mix of monoclonal abs
Stool Antigen Test for the Diagnosis
of Helicobacter pylori Infection: a
Systematic Review
HELICOBACTER
Volume 9-Number 4-2004
Review article key points
• Aim was to review systematically the diagnostic accuracy of HP stool antigen test
• Cost effectiveness
• HpSA test can be definitively considered an accurate noninvasive method for diagnosis
of H. pylori infection in untreated patients
• Recently approved by FDA for use in primary diagnosis of H. pylori and in monitoring
of posttreatment outcome
Accuracy to confirm eradication 4 or more weeks
after completing therapy
Advantages Disadvantages
• Easy & simple to perform • Disagreeable task / compliance
• Rapid (approximately 90 minutes)
• 60% pts prefer UBT vs. 5% for
• Requires only 1 stool specimen (UBT
stool, 35% no preference
needs 2 breath samples)
• Does not require technician or nurse
• Can be collected in privacy of home
• Stored at 2-8o C up to 3 days,
indefinitely at -20o C
• Unfrozen should be sent within 1 day
to lab; risk decreased sensitivity
Cost Effectiveness
• Before treatment
– Serology had lowest cost per correct diagnosis, but low diagnostic
accuracy
– At low (30%) & intermediate (60%) prevalence, HpSA test more accurate
(93%), average cost $126 per correct diagnosis
(Vakil et al, 2000)
• Cost of HpSA test in state of flux
• Confirmation of eradication (cost per correct diagnosis)
– UBT - $136
– Rapid urease test- $1105
– HpSA – $82
(Vakil et al, 2000)
References
Bilardi C, Biaginni R, Dulbecco P, et al. Stool antigen assay (HpSA) is less reliable than urea breath test for post-treatment diagnosis in Helicobacter pylori
infection. Aliment Pharmacology Therapy 2002; 16: 1733-8.
Gatta, Luigi et al. Effect of Proton Pump Inhibitors and antacid Therapy on 13C Urea Breath Tests and Stool Test for Helicobacter Pylori infection.
American Journal of Gastroenterology 2004; 10: 823-829.
Gisbert, Javier P., Pajares, Jose Maria. Stool Antigen Test for the Diagnosis of Helicobacter pylori Infection: a Systematic Review. Helicobacter 2004; 9:
347-368.
Kindermann, Angelika et al. Influence of Age on C-Urea Breath Test Results in Children. Journal of Pediatric Gastroenterology 2000; 30: 85091.
Malfertheiner, Peter, Megraud, Francis and O’Morain, Colm. Guidelines for the Management of Helicobacter pylori Infection, Summary of the Maastricht-
3 2005 Consensus Report. European Gastroenterology Review 2005.
Makristathis, a. Non-invasive Helicobacter pylori diagnosis: Stool of breath tests? Digestive and Liver Disease 2005; 37: 732-734.
Masoero G, Lombardo L, Della Monica P, et al. Discrepancy between Helicobacter pylori stool antigen assay and urea breath test in the detection of
Helicobacter pylori infection. Dig Liver Disease 2000; 32: 285-290.
References
Treviasani L, Sartori S, Galvani F, et al. Evaluation of a new enzyme immunoassay for detecting Helicobacter pylori in
feces: a prospective pilot study. Am J Gastroenterolgy 1999; 94: 1830-3.
Vakil NB, Ofman J, Vaira D. Cost-effectivenss of tests for the detection of failed eradication after treatment of H. pylori
infection. Gastroenterolgy 2000: 118: A508.
Vakil N, Rhew D, Soll A, Ofman JJ. The cost-effectiveness of diagnostic testing strategies for Helicobacter pylori. Am J
Gastroenterology. 20000: 95: 1691-8.
Varia D, Holton J, Menegatti M, et al. Invasive and non-invasive tests for Helicobacter pylori infection. Alimentary
Pharmacology Therapy 2000: 14: 13-22.
Varia, D., Gatta, L., Ricci, C. Stool Test for Helciobacter pylori. Digestive and Liver Disease 2004; 36: 446-447.