Evaluation of the effects of a proton pump inhibitor on Helicobacter pylori stool antigen testing

• DOI: 10.1111/hel.12961
• Publication Date: 2023-02-25T02:48:25Z
• Authors: Yusaku Kajihara; Tadashi Shimoyama; Ichiro Mizuki
• Keywords: Antigens, Bacterial; Helicobacter pylori; Proton Pump Inhibitors; Sensitivity and Specificity; 3. Good health; Helicobacter Infections; Feces; 03 medical and health sciences; 0302 clinical medicine; Breath Tests; Humans; Urea; Lansoprazole; Prospective Studies

AbstractBackgroundSome patients find it difficult to discontinue proton pump inhibitors (PPIs). Unlike the 13C‐urea breath test (UBT), the stool antigen test (SAT), particularly when domestically produced kits are used, may be less likely to yield false‐negative results.MethodsThis prospective study included a convenience series of 35 healthy Japanese subjects. Based on a statistical calculation, acceptable numbers of subjects were considered at least 21 and 11 with and without Helicobacter pylori (H. pylori) infection, respectively. The H. pylori infection was determined using the UBT or rapid urease test. SATs were performed with three novel domestically produced kits (the rapid immunochromatography tests Quick Navi™‐H. pylori [Navi™] and Quick Chaser® H. pylori [Chaser®], and the bioluminescent enzyme immunoassay test BLEIA® ‘EIKEN’ H. pylori Antigen [BLEIA®]) before and after oral PPI administration (30 mg lansoprazole once daily for 14 days). For each kit, the sensitivities and specificities were calculated and compared before and after PPI administration. Furthermore, the cutoff index (COI) values of BLEIA® before and after PPI administration were compared in H. pylori‐infected subjects.ResultsH. pylori infection was detected in 68.6% (24/35) of the included subjects. The sensitivities and specificities before versus after PPI administration were as follows: 79.2% (19/24) and 100.0% (11/11) versus 75.0% (18/24) and 100.0% (11/11) for Navi™, respectively (p = 1); 87.5% (21/24) and 100.0% (11/11) versus 75.0% (18/24) and 100.0% (11/11) for Chaser®, respectively (p = .371); 100.0% (24/24) and 100.0% (11/11) versus 95.8% (23/24) and 100.0% (11/11) for BLEIA®, respectively (p = 1). The median COI values of BLEIA® before and after PPI administration were 1389.0 and 3207.25, respectively (p = .0839).ConclusionsIn stool specimens, H. pylori antigenicity is maintained even during PPI use. SAT using a bioluminescent enzyme immunoassay is particularly recommended because of its extremely high sensitivity.