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Clinical Evaluation of a Visual and Rapid Self-test Method for Detecting Helicobacter pylori Infection and Virulence Typing Using a Drop of Blood

Clinical Evaluation of a Visual and Rapid Self-test Method for Detecting Helicobacter pylori Infection and Virulence Typing Using a Drop of Blood

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400082329
Enrollment
Unknown
Registered
2024-03-26
Start date
2024-03-27
Completion date
Unknown
Last updated
2025-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Helicopter pylori infection

Interventions

Gold Standard:C13 blowing positive/negative serves as the "gold standard" for whether Hp is a current infected person
The combined diagnostic results of Hp typing method 1 (quantum dot immunofluorescence) and method 2 (immunoblotting) serve as the "gold standard" for Hp typing: Hp - ? type refers to the positive resu
Hp - type II refers to those whose results are both negative.
Index test:Helicobacter pylori (HP) typing detection kit (latex method)

Sponsors

The Second Affiliated Hospital of Army Medical University, PLA
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age: unlimited. 2. Gender: No gender limit. 3. Patients with symptoms such as upper abdominal pain, discomfort, acid reflux, heartburn, belching, etc. 4. Having a family history of gastric cancer or precancerous lesions. 5. The patient voluntarily joined this study.

Exclusion criteria

Exclusion criteria: 1. Take antibiotics, bismuth agents, H2 receptor blockers, or proton pump inhibitors within the past 4 weeks. 2. Previous history of Helicobacter pylori infection eradication or gastric surgery. 3. Alcohol or drug abuse. 4. Comprehensive judgment shows poor compliance and inability to accurately provide medical history, such as inability to cooperate in completing relevant testing items, obvious mental and psychological disorders, intellectual disabilities, or elderly dementia.

Design outcomes

Primary

MeasureTime frame
Kappa value;

Secondary

MeasureTime frame
sensitivity, Sen;specificity, Spe;positive predict value, +PV;negative predict value, -PV;

Countries

China

Contacts

Public ContactXia Xie

Second Affiliated Hospital of Army Medical University, PLA

Xiexia0128@163.com+86 134 5216 6767

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026