Noninvasive tests as a substitute for histology in the diagnosis of Helicobacter pylori infection

Martin Hahn, M (Brian) Fennerty, Christopher Corless, Nathan Magaret, David Lieberman, Douglas O. Faigel

Research output: Contribution to journalArticle

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Abstract

Background: Rapid urease tests for Helicobacter pylori have a sensitivity of 80% to 90%. Therefore histologic examination of gastric biopsies is recommended as a 'backup' diagnostic test in rapid urease test- negative patients. However, noninvasive tests (urea breath test, serology, whole blood antibody tests) may provide a more rapid diagnosis and be less expensive but offer similar accuracy. Methods: Sixty-seven patients (no prior treatment for H pylori, no proton pump inhibitors, antibiotics, or bismuth within 4 weeks) undergoing endoscopy for evaluation of dyspepsia symptoms and testing rapid urease test-negative by antral biopsy were enrolled. All had the following tests: gastric biopsies (2 antral, 1 fundus; H and E and Alcian Yellow stain) examined for gastritis and H pylori; 13C-UBT; capillary blood for whole blood rapid antibody tests: FlexSure HP, QuickVue, AccuStat, and Stat-Simple Pylori; serum for FlexSure HP; HM-CAP enzyme-linked immunoassay. H pylori infection was diagnosed (reference standard) if chronic gastritis was present on histology and at least 2 of the 3 following tests were positive: urea breath test, H pylori organisms unequivocally demonstrated in biopsies on special stain, and/or enzyme-linked immunoassay. The test and treatment costs per patient were calculated. Results: Of 67 patients with a negative rapid urease test, 4 were positive for H pylori. None had active peptic ulcer disease. Histology only identified I patient with organisms visible on special stain. Using chronic active gastritis (neutrophilic and mononuclear infiltrate) as a diagnostic criterion for H pylori, 6 patients would have been judged positive. However, only 2 of these were truly positive by the reference standard (positive predictive value 33%). Negative predictive value for presence of organisms and chronic active gastritis was 95% and 97%, respectively. All of the noninvasive tests identified all 4 truly positive patients correctly. Urea breath test and FlexSure whole blood assay yielded a substantial number of false-positive results (positive predictive value 31% and 36%, respectively); positive predictive value for the other tests ranged from 50% to 80%. All tests except histology had a negative predictive value of 100%. Histology was the most costly test (p <0.001 compared with all other tests), followed by urea breath test and HM-CAP serology (p <0.001 compared with all rapid antibody tests). Conclusions: Whole blood or serum antibody testing is a rapid, accurate, and cost- effective means for establishing H pylori status in rapid urease test- negative patients. Whole blood or serology rapid antibody testing should substitute for histology when the patient has not been previously treated for H pylori.

Original languageEnglish (US)
Pages (from-to)20-26
Number of pages7
JournalGastrointestinal Endoscopy
Volume52
Issue number1
StatePublished - Jul 2000

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Pylorus
Helicobacter Infections
Helicobacter pylori
Histology
Urease
Breath Tests
Gastritis
Urea
Serology
Antibodies
Biopsy
Coloring Agents
Immunoenzyme Techniques
Stomach
Predictive Value of Tests
Bismuth
Symptom Assessment
Proton Pump Inhibitors
Dyspepsia
Hematologic Tests

ASJC Scopus subject areas

  • Gastroenterology

Cite this

Noninvasive tests as a substitute for histology in the diagnosis of Helicobacter pylori infection. / Hahn, Martin; Fennerty, M (Brian); Corless, Christopher; Magaret, Nathan; Lieberman, David; Faigel, Douglas O.

In: Gastrointestinal Endoscopy, Vol. 52, No. 1, 07.2000, p. 20-26.

Research output: Contribution to journalArticle

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abstract = "Background: Rapid urease tests for Helicobacter pylori have a sensitivity of 80{\%} to 90{\%}. Therefore histologic examination of gastric biopsies is recommended as a 'backup' diagnostic test in rapid urease test- negative patients. However, noninvasive tests (urea breath test, serology, whole blood antibody tests) may provide a more rapid diagnosis and be less expensive but offer similar accuracy. Methods: Sixty-seven patients (no prior treatment for H pylori, no proton pump inhibitors, antibiotics, or bismuth within 4 weeks) undergoing endoscopy for evaluation of dyspepsia symptoms and testing rapid urease test-negative by antral biopsy were enrolled. All had the following tests: gastric biopsies (2 antral, 1 fundus; H and E and Alcian Yellow stain) examined for gastritis and H pylori; 13C-UBT; capillary blood for whole blood rapid antibody tests: FlexSure HP, QuickVue, AccuStat, and Stat-Simple Pylori; serum for FlexSure HP; HM-CAP enzyme-linked immunoassay. H pylori infection was diagnosed (reference standard) if chronic gastritis was present on histology and at least 2 of the 3 following tests were positive: urea breath test, H pylori organisms unequivocally demonstrated in biopsies on special stain, and/or enzyme-linked immunoassay. The test and treatment costs per patient were calculated. Results: Of 67 patients with a negative rapid urease test, 4 were positive for H pylori. None had active peptic ulcer disease. Histology only identified I patient with organisms visible on special stain. Using chronic active gastritis (neutrophilic and mononuclear infiltrate) as a diagnostic criterion for H pylori, 6 patients would have been judged positive. However, only 2 of these were truly positive by the reference standard (positive predictive value 33{\%}). Negative predictive value for presence of organisms and chronic active gastritis was 95{\%} and 97{\%}, respectively. All of the noninvasive tests identified all 4 truly positive patients correctly. Urea breath test and FlexSure whole blood assay yielded a substantial number of false-positive results (positive predictive value 31{\%} and 36{\%}, respectively); positive predictive value for the other tests ranged from 50{\%} to 80{\%}. All tests except histology had a negative predictive value of 100{\%}. Histology was the most costly test (p <0.001 compared with all other tests), followed by urea breath test and HM-CAP serology (p <0.001 compared with all rapid antibody tests). Conclusions: Whole blood or serum antibody testing is a rapid, accurate, and cost- effective means for establishing H pylori status in rapid urease test- negative patients. Whole blood or serology rapid antibody testing should substitute for histology when the patient has not been previously treated for H pylori.",
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AU - Fennerty, M (Brian)

AU - Corless, Christopher

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AU - Lieberman, David

AU - Faigel, Douglas O.

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N2 - Background: Rapid urease tests for Helicobacter pylori have a sensitivity of 80% to 90%. Therefore histologic examination of gastric biopsies is recommended as a 'backup' diagnostic test in rapid urease test- negative patients. However, noninvasive tests (urea breath test, serology, whole blood antibody tests) may provide a more rapid diagnosis and be less expensive but offer similar accuracy. Methods: Sixty-seven patients (no prior treatment for H pylori, no proton pump inhibitors, antibiotics, or bismuth within 4 weeks) undergoing endoscopy for evaluation of dyspepsia symptoms and testing rapid urease test-negative by antral biopsy were enrolled. All had the following tests: gastric biopsies (2 antral, 1 fundus; H and E and Alcian Yellow stain) examined for gastritis and H pylori; 13C-UBT; capillary blood for whole blood rapid antibody tests: FlexSure HP, QuickVue, AccuStat, and Stat-Simple Pylori; serum for FlexSure HP; HM-CAP enzyme-linked immunoassay. H pylori infection was diagnosed (reference standard) if chronic gastritis was present on histology and at least 2 of the 3 following tests were positive: urea breath test, H pylori organisms unequivocally demonstrated in biopsies on special stain, and/or enzyme-linked immunoassay. The test and treatment costs per patient were calculated. Results: Of 67 patients with a negative rapid urease test, 4 were positive for H pylori. None had active peptic ulcer disease. Histology only identified I patient with organisms visible on special stain. Using chronic active gastritis (neutrophilic and mononuclear infiltrate) as a diagnostic criterion for H pylori, 6 patients would have been judged positive. However, only 2 of these were truly positive by the reference standard (positive predictive value 33%). Negative predictive value for presence of organisms and chronic active gastritis was 95% and 97%, respectively. All of the noninvasive tests identified all 4 truly positive patients correctly. Urea breath test and FlexSure whole blood assay yielded a substantial number of false-positive results (positive predictive value 31% and 36%, respectively); positive predictive value for the other tests ranged from 50% to 80%. All tests except histology had a negative predictive value of 100%. Histology was the most costly test (p <0.001 compared with all other tests), followed by urea breath test and HM-CAP serology (p <0.001 compared with all rapid antibody tests). Conclusions: Whole blood or serum antibody testing is a rapid, accurate, and cost- effective means for establishing H pylori status in rapid urease test- negative patients. Whole blood or serology rapid antibody testing should substitute for histology when the patient has not been previously treated for H pylori.

AB - Background: Rapid urease tests for Helicobacter pylori have a sensitivity of 80% to 90%. Therefore histologic examination of gastric biopsies is recommended as a 'backup' diagnostic test in rapid urease test- negative patients. However, noninvasive tests (urea breath test, serology, whole blood antibody tests) may provide a more rapid diagnosis and be less expensive but offer similar accuracy. Methods: Sixty-seven patients (no prior treatment for H pylori, no proton pump inhibitors, antibiotics, or bismuth within 4 weeks) undergoing endoscopy for evaluation of dyspepsia symptoms and testing rapid urease test-negative by antral biopsy were enrolled. All had the following tests: gastric biopsies (2 antral, 1 fundus; H and E and Alcian Yellow stain) examined for gastritis and H pylori; 13C-UBT; capillary blood for whole blood rapid antibody tests: FlexSure HP, QuickVue, AccuStat, and Stat-Simple Pylori; serum for FlexSure HP; HM-CAP enzyme-linked immunoassay. H pylori infection was diagnosed (reference standard) if chronic gastritis was present on histology and at least 2 of the 3 following tests were positive: urea breath test, H pylori organisms unequivocally demonstrated in biopsies on special stain, and/or enzyme-linked immunoassay. The test and treatment costs per patient were calculated. Results: Of 67 patients with a negative rapid urease test, 4 were positive for H pylori. None had active peptic ulcer disease. Histology only identified I patient with organisms visible on special stain. Using chronic active gastritis (neutrophilic and mononuclear infiltrate) as a diagnostic criterion for H pylori, 6 patients would have been judged positive. However, only 2 of these were truly positive by the reference standard (positive predictive value 33%). Negative predictive value for presence of organisms and chronic active gastritis was 95% and 97%, respectively. All of the noninvasive tests identified all 4 truly positive patients correctly. Urea breath test and FlexSure whole blood assay yielded a substantial number of false-positive results (positive predictive value 31% and 36%, respectively); positive predictive value for the other tests ranged from 50% to 80%. All tests except histology had a negative predictive value of 100%. Histology was the most costly test (p <0.001 compared with all other tests), followed by urea breath test and HM-CAP serology (p <0.001 compared with all rapid antibody tests). Conclusions: Whole blood or serum antibody testing is a rapid, accurate, and cost- effective means for establishing H pylori status in rapid urease test- negative patients. Whole blood or serology rapid antibody testing should substitute for histology when the patient has not been previously treated for H pylori.

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