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Clinical evaluation of a rapid test for Helicobactor pylori infection and virulence typing by a drop of blood

Evaluation of clinical application of rapid detection of Hp infection and virulence by typing trace blood

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400082209
Enrollment
Unknown
Registered
2024-03-22
Start date
2024-04-01
Completion date
Unknown
Last updated
2025-02-24

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

Conditions

Helicobacter pylori infection

Interventions

Gold Standard:Helicobacter pylori typing test kit (National instrument injection standard 20203400330, quantum dot immunofluorescence method) and Helicobacter pylori antibody typing test kit (National
Index test:Evaluation of consistency, sensitivity, specificity, predictive value, accuracy and other indicators of rapid typing kit for detecting Hp toxicity in trace blood.

Sponsors

The Second Affiliated Hospital of the Chinese People's Liberation Army Army Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 80 Years

Inclusion criteria

Inclusion criteria: 1.Age: unlimited; 2.Gender: unlimited; 3.Abdominal discomfort, pain, acid reflux, belching, pain and other symptoms; 4.Family history of gastric cancer or precancerous lesions; 5.The patients volunteered to join the study.

Exclusion criteria

Exclusion criteria: 1. Serious cardiovascular system diseases, psychiatric diseases and coagulation dysfunction; 2. Take antibiotics, bismuth, H2 blockers, or proton pump inhibitors within the last 4 weeks; 3.History of the eradication of helicobacter pylori and history of gastric surgery; 4. During pregnancy and lactation; 5. Alcohol or drug abusers; 6. Poor compliance, unable to provide accurate medical history or unable to complete blowing or blood collection; 7. Refusal to participate in this study.

Design outcomes

Primary

MeasureTime frame
consistency;

Secondary

MeasureTime frame
sensitivity;specificity;positive predictive value;negative predictive value;

Countries

China

Contacts

Public ContactXie Xia

The Second Affiliated Hospital of the Chinese People's Liberation Army Army Medical University

Xiexia0128@163.com+86 134 5216 6767

Outcome results

None listed

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