RUT vs. Molecular Testing for H. Pylori

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

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.

Study Overview

• Status: Completed
• Conditions: H.Pylori Infection

Detailed Description

The investigators aim to compare the diagnostic accuracy of the RUT and molecular testing, and identify clinical factors associated with the discordant results between the two methods.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• South Korea
  • Seoul, South Korea, 04401
    • Digestive Disease Center, Soonchunhyang University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

H. pylori-infected patients

Description

Inclusion Criteria:

• Gastroscopy can be performed
• H. pylori test and pathological analysis can be performed

Exclusion Criteria:

• Age < 20 or > 80 years
• Anemia (serum hemoglobin level < 10 g/dL)
• Severe systemic disease
• Advanced chronic liver disease
• Use of certain medications, including proton pump inhibitors, H2- receptor antagonists, or antibiotics
• History of H. pylori eradication
• Drug allergy to antibiotics
• History of gastric surgery
• Recent history of upper gastrointestinal bleeding

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Current H. pylori infection status	RUT or molecular testing	1 day

Collaborators and Investigators

• Sponsor: Soonchunhyang University Hospital
• Investigators: Principal Investigator: Jun-Hyung Cho, M.D., Soonchunhyang University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2024
• Primary Completion (Actual): December 31, 2025
• Study Completion (Actual): December 31, 2025

Study Registration Dates

• First Submitted: November 10, 2024
• First Submitted That Met QC Criteria: November 10, 2024
• First Posted (Actual): November 12, 2024

Study Record Updates

• Last Update Posted (Actual): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: SCH-HP-2024-12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No