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First page of Is the Helicobacter pylori stool antigen test with the bioluminescent enzyme immunoassay affected by proton pump inhibitors?

Background and aim: Proton pump inhibitors (PPIs) can lead to false-negative results in Helicobacter pylori stool antigen (HpSA) testing. A new bioluminescent enzyme immunoassay (BLEIA)-based HpSA test was introduced. This study aimed to evaluate the sensitivity of this test in patients on PPIs and compare its sensitivity with that of the enzyme immunoassay (EIA). Methods: We included patients without a history of H. pylori eradication who were diagnosed as H. pylori-positive via culture, microscopy, rapid urease tests, urea breath tests, serum H. pylori antibody tests, or HpSA tests. The sensitivity of HpSA detection was compared among patients based on their PPI intake using both BLEIA and conventional EIA. Results: Enrolment occurred from December 2020 to July 2022 across 10 facilities, with 109 patients enrolled in both the PPI and non-PPI groups. The sensitivity of BLEIA was 65.9% in the PPI group and 87.1% in the non-PPI group, showing a difference of –22.0% (95% CI: –11.0% to –32.9%) (P=0.0003). For EIA, the sensitivity was 54.1% in the PPI group and 72.4% in the non-PPI group, with a difference of –18.3% (95% CI: –5.5% to –30.4%) (P=0.0076). Significant differences in sensitivity were observed for both BLEIA and EIA between the PPI and non-PPI groups (p=0.005 and p<0.0001, respectively), with BLEIA demonstrating higher sensitivity. Conclusions: This study indicated that the sensitivity of HpSA detection using BLEIA decreased under PPI administration. Additionally, BLEIA may have higher sensitivity than EIA.

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2025
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License .
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