Comparative Diagnostic Performance of Rapid Urease Test Versus Molecular Testing for Diagnosis of Helicobacter Pylori

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

The rapid urease test (RUT) is frequently performed for diagnosis of Helicobacter pylori infection in clinical practice. The RUT is a simple and inexpensive method that utilizes a commercial kit containing urea and a pH indicator such as phenol red. In the presence of H. pylori urease, urea is hydrolyzed to ammonia, which raises the pH of the medium, and changes the color of the kit from yellow to magenta or pink. The sensitivity and specificity of RUT were reported to range between 80-100% and 97-99%, respectively. When endoscopy is performed, RUT is known as the first-line method used for H. pylori diagnosis. However, RUT is an indirect test method, and has the disadvantage of causing false positivity due to other urease-producing bacteria. To date, gold standards for H. pylori diagnosis are culture and histological examination Because H. pylori is a rather fastidious and slow-growing bacterium, antimicrobial susceptibility testing using culture methods is time-consuming (10-14 days) and requires specific expertise. Recently, dual priming oligonucleotide (DPO)-based multiplex polymerase chain reaction (PCR) was developed to diagnose H. pylori infection. Moreover, molecular testing can identify point mutations related to clarithromycin resistance. It can be performed in a standard thermocycler and takes only 4 h to complete. The concordance rate between conventional clarithromycin susceptibility testing and DPO-PCR was excellent up to 95%. However, there was no comparison study between RUT and molecular testing for H. pylori diagnosis.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Maximum Age: 80
Healthy Volunteers: f
View:

• Gastroscopy can be performed

• H. pylori test and pathological analysis can be performed

Locations
Other Locations
Republic of Korea
Digestive Disease Center, Soonchunhyang University Hospital
RECRUITING
Seoul
Contact Information
Primary
Jun-Hyung Cho, M.D.
chojhmd@naver.com
+82-2-709-9202
Time Frame
Start Date: 2024-11-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 100
Treatments
RUT group
The rapid urease test (RUT) was performed for diagnosis of H. pylori infection.
Molecular test group
DPO-PCR testing was performed for diagnosis of H. pylori infection.
Sponsors
Leads: Soonchunhyang University Hospital

This content was sourced from clinicaltrials.gov