Comparison of Noninvasive Diagnostic Tests for Helicobacter pylori Infection

Objectives: Since the 13C-urea breath test (UBT) has become a highly reliable method for the noninvasive diagnosis of Helicobacter pylori infection, this study was performed in order to compare the sensitivity, specificity and accuracy among noninvasive tests including capsule UBT, conventional UBT and serology in the diagnosis of H. pylori infection. Patients and Methods: One hundred patients received capsule UBT, conventional UBT and gave blood samples for the diagnosis of H. pylori infection. Upper gastrointestinal endoscopy was performed in all patients. H. pylori infection was defined as the presence of a positive culture or positive results of both histology and rapid urease test (CLO test). McNemar’s test was used to determine the significance of differences among capsule UBT, conventional UBT and serology. Differences were considered significant at p < 0.05. Results: According to the predefined criteria, the sensitivity, specificity, positive predictive value and negative predictive value of capsule UBT, conventional UBT and serology was 100, 95.7, 96.4 and 100%; 100, 85.1, 88.3 and 100%, and 90.6, 85.1, 82.7 and 88.9%, respectively. The accuracy of capsule UBT was higher than that of conventional UBT and serology (98 vs. 93 and 88%, respectively). Capsule UBT had a similar ability for the detection of H. pylori infection compared with conventional UBT and serology (McNemar’s test, p > 0.05). Conclusions: According to our study, capsule UBT was highly accurate compared with other noninvasive tests including conventional UBT and serology. It could become a good alternative to endoscopy for the diagnosis of H. pylori infection.

[1]  S. Nahar,et al.  Non-invasive diagnosis of H pylori infection: evaluation of serological tests with and without current infection marker CIM. , 2008, World journal of gastroenterology.

[2]  H. Tseng,et al.  Polymerase chain reaction: a sensitive method for detecting Helicobacter pylori infection in bleeding peptic ulcers. , 2005, World journal of gastroenterology.

[3]  Ren-Shyan Liu,et al.  Capsule 13 C-urea breath test for the diagnosis of Helicobacter pylori infection , 2005 .

[4]  Ren-Shyan Liu,et al.  Clinical Significance of Oral Urease in Diagnosis of Helicobacter pylori Infection by [13C]Urea Breath Test , 2001, Digestive Diseases and Sciences.

[5]  P. Hsu,et al.  Endoscopic 13C-urea breath test for the diagnosis of Helicobacter pylori infection. , 2003, Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver.

[6]  P. Hsu,et al.  Follow-up of Helicobacter pylori status by using 13C-urea breath test in nonulcer dyspeptic patients after eradication therapy. , 2001, Zhonghua yi xue za zhi = Chinese medical journal; Free China ed.

[7]  L. Ger,et al.  A 15‐minute [13C]‐urea breath test for the diagnosis of Helicobacter pylori infection in patients with non‐ulcer dyspepsia , 2000, Journal of gastroenterology and hepatology.

[8]  Y. Yamazaki,et al.  Endoscopic [13C]‐urea breath test for quantification of Helicobacter pylori infection , 2000, Journal of gastroenterology and hepatology.

[9]  P. Rutgeerts,et al.  The 13C-urea breath test as a predictor of intragastric bacterial load and severity of Helicobacter pylori gastritis. , 1998, Scandinavian journal of clinical and laboratory investigation.

[10]  Jones Db,et al.  Testing for Helicobacter pylori infection after antibiotic treatment. , 1997 .

[11]  M. Fromm,et al.  13C-urea breath test in Helicobacter pylori diagnosis and eradication. Correlation to histology, origin of 'false' results, and influence of food intake. , 1997, Scandinavian journal of gastroenterology.

[12]  D. Jones,et al.  Testing for Helicobacter pylori infection after antibiotic treatment. , 1997, The American journal of gastroenterology.

[13]  R. Spiller,et al.  Effect of a test meal on the intragastric distribution of urea in the 13C-urea breath test for Helicobacter pylori. , 1995, Gut.

[14]  T. Azuma,et al.  Endoscopic cross-infection with Helicobacter pylori , 1995, The Lancet.

[15]  T. Schubert,et al.  [13C]urea breath test to confirm eradication of Helicobacter pylori. , 1995, The American journal of gastroenterology.

[16]  S. Pauwels,et al.  Quantification of Helicobacter pylori infection in gastritis and ulcer disease using a simple and rapid carbon-14-urea breath test. , 1991, Journal of nuclear medicine : official publication, Society of Nuclear Medicine.

[17]  J. M. Grant,et al.  The fetal heart rate trace is normal, isn't it? Observer agreement of categorical assessments , 1991, The Lancet.

[18]  E. Rauws,et al.  Patient-to-patient transmission of Campylobacter pylori infection by fiberoptic gastroduodenoscopy and biopsy. , 1990, The Journal of infectious diseases.

[19]  J. Fleiss,et al.  Statistical methods for rates and proportions , 1973 .

[20]  J. Gisbert,et al.  : 13 C-urea breath test in the diagnosis of Helicobacter pylori infection – a critical review , 2022 .