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Lsothermal Amplification Analyzer Clinical Trials

Lsothermal Amplification Analyzer Clinical Trials

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200060140
Enrollment
Unknown
Registered
2022-05-20
Start date
2022-05-19
Completion date
Unknown
Last updated
2024-04-22

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

Conditions

Novel Coronavirus Pneumonia (COVID-19)

Interventions

Gold Standard:Real-time fluorescence quantitative PCR instrument
Index test:Isothermal Amplification Analyzer

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 100 Years

Inclusion criteria

Inclusion criteria: 1. No age limit; 2. No gender limit; 3. With traceable clinical diagnosis background, gender, age and other case information; 4. Suspected patients with novel coronavirus pneumonia; 5. Subjects must give informed consent to this study before the trial, and voluntarily or signed a written informed consent form by their guardian.

Exclusion criteria

Exclusion criteria: 1. Incomplete case information (sex, age, background information on clinical diagnosis and other demographic data, etc.); 2. The storage conditions of the samples do not meet the requirements of the instructions; 3. The sample is suspected to be contaminated; 4. The investigators considered that the subjects had any other factors that made them inappropriate to participate in this trial.

Design outcomes

Primary

MeasureTime frame
2019-nCoV test results;Positive coincidence rate;Negative coincidence rate;Overall coincidence rate;Kappa;

Countries

China

Contacts

Public ContactLi Weimin

West China Hospital of Sichuan University

weimi003@yahoo.com+86 189 8060 1009

Outcome results

None listed

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