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

Abstract

Background Some 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. Methods This 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. Results H. 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). Conclusions In 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.

Clinical Utility of <i>Helicobacter pylori</i> Stool Antigen Testing with a Bioluminescent Enzyme Immunoassay Using a Fecal Occult Blood Test Container

“…A BLEIA, although used less commonly than an EIA/ELISA, has been reported to have good sensitivity and specificity and is hardly affected by the presence of oral PPIs. Its main strength lies in its ability to accurately diagnose H. pylori (6,7). We hope that BLEIAs will be more widely used in the future to reduce the number of false-negative H. pylori stool antigen test results.…”

“…The BLEIA™ 'EIKEN' H. pylori antigen test (Eiken Chemical, Tokyo, Japan) is based on a bioluminescent enzyme immunoassay (BLEIA) and was developed to detect H. pylori antigens in feces with high sensitivity (5)(6)(7)(8). This method was reported to be largely unaffected by the oral administration of proton pump inhibitors (PPIs) (7), Despite its effectiveness, however, the BLEIA is not widely used because it requires the collection of stool samples in a dedicated stool collection container (BL-stool collection container or BL container, BL Sampling Bottle; Eiken Chemical). If the H. pylori stool antigen could be measured using a BLEIA in samples stored in an S container, which is widely used for fecal occult blood testing in colorectal cancer screening, the highly accurate BLEIA could then be more widely implemented.…”

Diagnostic Accuracy of a Novel Stool Antigen Test for <i>Helicobacter pylori</i> Infection in a Medical Checkup Setting: A Prospective Cohort Study

“…Very recently, the BLEIA was reported to have better sensitivity than immuno-enzymatic and immunochromatographic methods in a comparative study of six commercially available products in Japan ( 15 ). Subsequently, Kajihara et al compared 3 commercially available products in Japan and reported that the BLEIA showed high diagnostic accuracy at 100% (35/35) and 97.1% (34/35) before and after proton pump inhibitor (PPI) use, respectively, and was not easily affected by PPI use ( 16 ). To date, the diagnostic accuracy of SAT has been reported to have 96-100% sensitivity/97-100% specificity, and 75-90% sensitivity/96-100% specificity before and after eradication, respectively ( 2 ).…”

<i>Helicobacter pylori</i> Diagnosis and Treatment in Africa: The First Lagos Consensus Statement of the African Helicobacter and Microbiota Study Group

“…It is important to determine treatment outcomes to distinguish between successful eradication and recrudescence to prevent the risk of underdiagnosis of treatment failure. Noninvasive tests are recommended, such as UBT and SAT [8,152,[162][163][164][165]. Treatment outcomes should be performed not less than 4 weeks after the completion of eradication therapy.…”