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Clinical and Diagnostic Laboratory Immunology, July 2001, p. 718-723, Vol. 8, No. 4
Asociación Benéfica
PRISMA,1 Naval Medical Research Center
Detachment,5 Universidad Peruana
Cayetano Heredia,3 Acambis Inc.,
Cambridge, Mass.,7 and Japanese Peruvian
Polyclinic,6 Lima, Peru; Walter Reed
Army Institute of Research, Washington,
D.C.2; and The Johns Hopkins School
of Public Health and Hygiene, Baltimore, Maryland4
Received 10 November 2000/Returned for modification 15 December
2000/Accepted 21 March 2001
The Helicobacter pylori stool antigen enzyme
immunoassay (HpSA) was evaluated during posttreatment follow-up of
patients in a country with a very high prevalence of H. pylori infection. From among 273 dyspeptic individuals (18 to 55 years) initially recruited from a shantytown in Lima, Peru, 238 participants who met the inclusion criteria and were suspected to be
H. pylori positive based on 14C urea breath
test (UBT) results underwent endoscopy. Participants with
endoscopy-proven infections received standard eradication therapy and
were monitored by UBT and HpSA at 1 month following treatment and at
3-month intervals for 9 months posttreatment. A second endoscopy was
performed if UBT results showed evidence of treatment failure or
H. pylori recurrence. Biopsy results were considered the
"gold standard" in all analyses. Among patients who underwent
endoscopy, HpSA had a pretreatment sensitivity of 93%. Two-hundred
thirty patients completed the treatment regimen, of whom 201 (93%)
were considered to have had successful treatment outcomes based on a
negative follow-up UBT. Thirty-two patients with UBT-defined treatment
failures or H. pylori recurrences at any point during the
9-month follow-up underwent a second endoscopy. In the posttreatment
setting, HpSA had an overall sensitivity of 73% and a specificity of
67%. Agreement between UBT and HpSA diminished throughout the
follow-up. Among 14 participants in whom HpSA remained positive at 1 month following treatment despite UBT evidence of treatment success, 12 (86%) became HpSA negative within 3 months posttreatment. Although
this study confirmed the validity of the HpSA in the initial assessment
of dyspeptic patients, the test demonstrated a reduced overall accuracy
in the detection of treatment failures and H. pylori
recurrences during 9 months of posttreatment follow-up. Furthermore, in
some patients it may take up to 3 months after successful eradication
for antigen shedding to diminish to levels within the negative HpSA range.
1071-412X/01/$04.00+0 DOI: 10.1128/CDLI.8.4.718-723.2001
Copyright © 2001, American Society for Microbiology. All rights reserved.
Posttreatment Follow-Up of Helicobacter
pylori Infection Using a Stool Antigen Immunoassay
*
Corresponding author. Mailing address: The Johns
Hopkins School of Hygiene and Public Health, Department of
International Health, 615 N. Wolfe St., Room W3501, Baltimore MD 21205. Phone: (410) 614-3959 or -3639. Fax: (410) 614-6060. E-mail:
rgilman{at}prisma.org.pe.
Gastrointestinal Physiology Working Group senior members are Robert
Berendson, Robert H. Gilman, Raul Leon-Barua, Alberto Ramirez-Ramos,
and Sixto Recavarren-Arce.
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