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Noninvasive tests as a substitute for histology in the diagnosis of Helicobacter pylori infection.
Gastrointest Endosc 2000; 52(1):20-6GE

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&E and Alcian Yellow stain) examined for gastritis and H pylori; (13)C-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 1 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.

Authors+Show Affiliations

Division of Gastroenterology, Portland VA Medical Center and Oregon Health Sciences University, OR 97201, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

10882957

Citation

Hahn, M, et al. "Noninvasive Tests as a Substitute for Histology in the Diagnosis of Helicobacter Pylori Infection." Gastrointestinal Endoscopy, vol. 52, no. 1, 2000, pp. 20-6.
Hahn M, Fennerty MB, Corless CL, et al. Noninvasive tests as a substitute for histology in the diagnosis of Helicobacter pylori infection. Gastrointest Endosc. 2000;52(1):20-6.
Hahn, M., Fennerty, M. B., Corless, C. L., Magaret, N., Lieberman, D. A., & Faigel, D. O. (2000). Noninvasive tests as a substitute for histology in the diagnosis of Helicobacter pylori infection. Gastrointestinal Endoscopy, 52(1), pp. 20-6.
Hahn M, et al. Noninvasive Tests as a Substitute for Histology in the Diagnosis of Helicobacter Pylori Infection. Gastrointest Endosc. 2000;52(1):20-6. PubMed PMID: 10882957.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Noninvasive tests as a substitute for histology in the diagnosis of Helicobacter pylori infection. AU - Hahn,M, AU - Fennerty,M B, AU - Corless,C L, AU - Magaret,N, AU - Lieberman,D A, AU - Faigel,D O, PY - 2000/7/7/pubmed PY - 2000/9/30/medline PY - 2000/7/7/entrez SP - 20 EP - 6 JF - Gastrointestinal endoscopy JO - Gastrointest. Endosc. VL - 52 IS - 1 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&E and Alcian Yellow stain) examined for gastritis and H pylori; (13)C-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 1 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. SN - 0016-5107 UR - https://www.unboundmedicine.com/medline/citation/10882957/Noninvasive_tests_as_a_substitute_for_histology_in_the_diagnosis_of_Helicobacter_pylori_infection_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0016-5107(00)28042-5 DB - PRIME DP - Unbound Medicine ER -