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Rapid Detection of Fecal Antigen of Helicobacter pylori Infection Based on Double Antibody Sandwich Detection Technology
Published on: May 23, 2025
Stool antigen tests for the detection of Helicobacter pylori in children
Kaija-Leena Kolho1, Timo Klemola, Antti Koivusalo
1Hospital for Children and Adolescents, Box 281, FIN-00029 Helsinki, Finland. kaija-leena.kolho@helsinki.fi
Insights
Stool antigen tests accurately detect Helicobacter pylori in children. The HpStar assay showed high sensitivity and specificity, performing excellently in young patients, even with rectal swab samples.
Area of Science:
- Pediatric Gastroenterology
- Microbiology
- Diagnostic Testing
Background:
- Helicobacter pylori infection is a significant global health concern, particularly in children.
- Accurate and non-invasive diagnostic methods are crucial for managing H. pylori in pediatric populations.
Purpose of the Study:
- To evaluate the diagnostic performance of the HpStar stool antigen test for H. pylori detection in children.
- To compare the HpStar test with other commercially available stool antigen tests and biopsy-based methods.
Main Methods:
- Stool specimens from 102 children were analyzed using the HpStar monoclonal antibody-based enzyme immunoassay.
- Rectal cotton swab specimens were used in 28 cases during endoscopy.
- Parallel testing was performed with Premium Platinum HpSA and ImmunoCardSTAT! rapid test for a subset of specimens.
Main Results:
- The HpStar test demonstrated high sensitivity (0.95) and specificity (0.90) compared to biopsy-based methods.
- Rectal cotton swab specimens yielded accurate results in 24 out of 28 cases.
- The HpStar and HpSA tests achieved 98% accuracy, while ImmunoCardSTAT! had 96% accuracy, indicating excellent performance in young children.
Conclusions:
- The HpStar stool antigen test is a reliable and accurate method for diagnosing H. pylori infection in children.
- Stool antigen testing, including the HpStar assay, offers an excellent diagnostic option for pediatric H. pylori screening and management.
Abstract:
Stool specimens from 102 children (median age = 6.0 years; Helicobacter pylori in biopsy specimens, n = 43) were tested for H. pylori with the monoclonal antibody-based enzyme immunoassay HpStar. In 28 cases, the specimen was obtained with a rectal cotton swab during endoscopy. The sensitivity and specificity of the HpStar were 0.95 and 0.90, respectively, as compared with biopsy-based methods. The rectal cotton swab specimen gave accurate results in 24 of the 28 cases. Storage of specimens for 1, 3, or 7 days (n = 6) had a minor effect on the results, but one specimen's originally positive value on borderline turned negative when it was kept in room temperature. Forty-eight specimens were tested in parallel with all 3 tests used: HpStar, Premium Platinum HpSA, and the rapid test ImmunoCardSTAT! The accuracy rates of the tests were 98% for the HpSA and HpStar and 96% for the ImmunoCardSTAT! The performance of the stool antigen tests was excellent in young children.
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