Korean J Intern Med.  2016 Jan;31(1):40-45. 10.3904/kjim.2016.31.1.40.

New monoclonal antibody-based test for Helicobacter pylori urease in gastric tissue

• Kim DH
• Kim HD
• Park H
• Choi S
• Beom JW
• Kim WJ
• Park CK
• Lee YJ
• Park JY
• Kim HR
• Park C
• Joo YE
• Jung YD

• KMID: 2373771
• DOI: http://doi.org/10.3904/kjim.2016.31.1.40

Abstract

BACKGROUND/AIMS
To evaluate a new monoclonal antibody for Helicobacter pylori urease in gastric tissue.
METHODS
A total of 107 volunteers were enrolled. All subjects underwent a 13C-urea breath test and esophagogastroduodenoscopy. Gastric aspirates were analyzed for pH and ammonia. Six biopsy specimens in the gastric antrum and body were obtained for a rapid urease test and histology. The new monoclonal antibody-based H. pylori urease test (HPU) was performed to rapidly and qualitatively detect urease in two biopsy specimens.
RESULTS
H. pylori infection was diagnosed in 73 subjects. The sensitivity and specificity of the HPU was 89% and 74%, respectively. The subjects were divided into two groups: one with true-positive and true-negative HPU results (n = 90) and the other with false-positive and false-negative HPU results (n = 17). Across all subjects, ammonia levels were 900.5 +/- 646.7 and 604.3 +/- 594.3 mumol/L (p > 0.05), and pH was 3.37 +/- 1.64 and 2.82 +/- 1.51 (p > 0.05). Sensitivity was higher in the presence of atrophic gastritis or intestinal metaplasia.
CONCLUSIONS
HPU detected H. pylori in approximately 10 min. Gastric aspirate ammonia and pH levels did not affect the test results. Sensitivity was good in the presence of atrophic gastritis or intestinal metaplasia.

Keyword

Helicobacter pylori; Urease; Monoclonal antibody-based test

MeSH Terms

Adult
Antibodies, Monoclonal/*immunology
Bacterial Proteins/*analysis/immunology
Biomarkers/analysis
Biopsy
False Negative Reactions
False Positive Reactions
Female
Gastritis, Atrophic/*diagnosis/microbiology
Helicobacter Infections/*diagnosis/microbiology
Helicobacter pylori/*enzymology/immunology
Humans
*Immunologic Tests
Male
Metaplasia
Middle Aged
Predictive Value of Tests
Pyloric Antrum/*microbiology/pathology
Reproducibility of Results
Time Factors
Urease/*analysis/immunology
Workflow
Antibodies, Monoclonal
Bacterial Proteins
Biomarkers
Urease