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 17.4%. 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.
S. Kitt, None
M. Guo, None
D. Sabuda, None
C. Naugler, None
D. Church, None
D. Pillai, Diasorin: None , Educational grant .