New fecal test for non-invasive Helicobacter pylori detection: A diagnostic accuracy study

Andrea Iannone, Floriana Giorgio, Francesco Russo, Giuseppe Riezzo, Bruna Girardi, Maria Pricci, Suetonia C Palmer, Michele Barone, Mariabeatrice Principi, Giovanni Fm Strippoli, Alfredo Di Leo, Enzo Ierardi, Andrea Iannone, Floriana Giorgio, Francesco Russo, Giuseppe Riezzo, Bruna Girardi, Maria Pricci, Suetonia C Palmer, Michele Barone, Mariabeatrice Principi, Giovanni Fm Strippoli, Alfredo Di Leo, Enzo Ierardi

Abstract

Aim: To assess the diagnostic accuracy of a new fecal test for detecting Helicobacter pylori (H. pylori), using13C-urea breath test as the reference standard, and explore bacterial antibiotic resistance.

Methods: We conducted a prospective two-center diagnostic test accuracy study. We enrolled consecutive people≥ 18 years without previous diagnosis of H. pylori infection, referred for dyspepsia between February and October 2017. At enrollment, all participants underwent 13C-urea breath test. Participants aged over 50 years were scheduled to undergo upper endoscopy with histology. Participants collected stool samples 1-3 d after enrollment for a new fecal investigation (THD fecal test). The detection of bacterial 23S rRNA subunit gene indicated H. pylori infection. We also used the index diagnostic test to examine mutations conferring resistance to clarithromycin and levofloxacin. Independent investigators analyzed index test and reference test standard results blinded to the other test findings. We estimated sensitivity, specificity, positive (PPV) and negative (NPV) predictive value, diagnostic accuracy, positive and negative likelihood ratio (LR), together with 95% confidence intervals (CI).

Results: We enrolled 294 consecutive participants (age: Median 37.0 years, IQR: 29.0-46.0 years; men: 39.8%). Ninety-five (32.3%) participants had a positive13C-urea breath test. Twenty-three (7.8%) participants underwent upper endoscopy with histology, with a full concordance between 13C-urea breath test and histology in detecting H. pylori infection. Four (1.4%) out of the 294 participants withdrew from the study after the enrollment visit and did not undergo THD fecal testing. In the 290 participants who completed the study, the THD fecal test sensitivity was 90.2% (CI: 84.2%-96.3%), specificity 98.5% (CI:96.8%-100%), PPV 96.5% (CI: 92.6%-100%), NPV 95.6% (CI: 92.8%-98.4%), accuracy 95.9% (CI: 93.6%-98.2%), positive LR 59.5(CI: 19.3-183.4), negative LR 0.10 (CI: 0.05-0.18). Out of 83 infected participants identified with the THD fecal test, 34 (41.0%) had bacterial genotypic changes consistent with antibiotic-resistant H. pylori infection. Of these, 27 (32.5%) had bacterial strains resistant to clarithromycin, 3 (3.6%) to levofloxacin, and 4 (4.8%) to both antibiotics.

Conclusion: The THD fecal test has high performance for the non-invasive diagnosis of H. pylori infection while additionally enabling the assessment of bacterial antibiotic resistances.

Keywords: 23S rRNA; Antibiotic resistance; Diagnostic accuracy; Fecal test; Feces; Helicobacter pylori; Molecular analysis; Stools.

Conflict of interest statement

Conflict-of-interest statement: Alfredo Di Leo is an advisory board member of THD Spa. Floriana Giorgio, Bruna Girardi and Maria Pricci are employees of THD Spa. All other authors declare no financial support or conflict of interest.

Figures

Figure 1
Figure 1
Flow diagram of participant recruitment in the study.
Figure 2
Figure 2
Post-test probability after positive and negative results on the THD fecal test for populations with different pre-test probabilities of Helicobacter pylori infection, based on likelihood ratios.

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Source: PubMed

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