AUG 29, 2019 08:00 AM PDT

Implementation of Helicobacter Pylori Stool Antigen Testing in a Large Metropolitan Center: A Prospective Comparative Diagnostic Trial

Sponsored by: DiaSorin
C.E. Credits: P.A.C.E. CE Florida CE
Speakers
  • Professor of Pathology and Laboratory Medicine and Medicine at the University of Calgary
    Biography
      Dr. Pillai is a Professor of Pathology and Laboratory Medicine and Medicine at the University of Calgary, and practices in both Medical Microbiology and Infectious Diseases. His research interest comprises translational studies related to improving cost-effectiveness and outcomes from the implementation of new diagnostic algorithms. A particular focus has been on point-of-care and near-patient diagnostics both at home and in resource-limited settings in order to reduce disparities. He has published close to 100 peer-reviewed articles, obtained over $1.5M in direct peer-reviewed funding and $6M as co-investigator over the last 10 years. He has trained several undergraduate, graduate, and post-doctoral scientists as well as clinical fellows. Dr. Pillai is a member of the College of American Pathologists Microbiology Committee, IDSA diagnostics committee, AMMI Canada Research and Grants Chair, and sits on several editorial boards related to Microbiology and Infectious Diseases.

    Abstract:

    DATE: August 29, 2019
    TIME: 8:00am PDT, 11:00am EDT

    Background: Clinical guidelines for H. pylori screening and post-treatment testing endorse the use of urea breath test (UBT), H. pylori stool antigen test (HpSAT), and biopsy-related tests. Due to protracted wait times at our patient service centers and non-compliance in children and elderly with complications for the UBT, we sought to compare UBT and HpSAT in the city of Calgary, Canada with a population close to 1.4 million people.

    Methods: To achieve this, a prospective diagnostic trial was performed comparing UBT to HpSAT in patients presenting with dyspepsia. A total of N=150 patients agreed to undergo UBT (13C-UBT kit, Helikit, Isodiagnostika Inc.) and consented to provide a stool specimen for simultaneous HpSAT testing (Diasorin LIAISON® XL H. pylori SA Monoclonal chemiluminescent immunoassay) in our centralized laboratory.

    Results: Our data show that concordant results were obtained in 148/150 (98.7%) patients with a positivity rate of 18%. One of two discrepants (UBT positive/HpSAT negative) resolved after repeat testing. Using UBT as the gold standard, HpSAT had a sensitivity of 96.30% (95% CI; 81.03% to 99.91%) and specificity of 100% (95% CI; 97.05% to 100.00%). A positive predictive value of 100% and negative predictive value of 99.2% (95% CI; 94.73% to 99.88%) was obtained. For patients where drug information was available, 38/130 (29.2%) had received an antibiotic associated with H.pylori in the preceding 12 months, with UBT and HpSAT providing concordant results in 37/38 (97.4%) of these individuals. Of note, 6/130 (4.6%) patients had received a specific combination anti-H.pylori treatment, and all 6/6 (100%) had concordant negative results suggesting successful eradication. A post-implementation economic evaluation of labor and materials associated with testing demonstrates a cost-savings of approximately USD 5.47 per specimen in this locale.

    Conclusion: Our study confirms that HpSAT is a viable alternative to UBT for H. pylori screening in our jurisdiction with equivalent test performance and cost-savings. Pre- and post-implementation analysis of test compliance rates, waiting times, and test turn around times will also be presented.

    Learning Objectives:

    • Gain understanding of H.pylori testing options
    • Understand challenges and benefits of utilizing  H.pylori stool antigen testing
    • Gain skills to effectively manage key clinician stakeholders

     

     

    LabRoots is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E. ® Program. By attending this webinar, you can earn 1 Continuing Education credit once you have viewed the webinar in its entirety.


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