Clinical and Diagnostic Laboratory Immunology, July 2001, p. 718-723, Vol. 8, No. 4
1071-412X/01/$04.00+0 DOI: 10.1128/CDLI.8.4.718-723.2001
Copyright © 2001, American Society for Microbiology. All rights reserved.
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.
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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