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Development and clinical application of novel coronavirus pneumonia (COVID-19) antigen reagent

Development and clinical application of novel coronavirus pneumonia (COVID-19) antigen reagent

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000031700
Enrollment
Unknown
Registered
2020-04-07
Start date
2020-04-21
Completion date
Unknown
Last updated
2020-04-13

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:clinical outcome
nucleic acid test
Index test:antigen reagent

Sponsors

Chinese PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
10 Years to 90 Years

Inclusion criteria

Inclusion criteria: (1)Complete sample information, including sample number, gender, age, sampling time, and clinical diagnosis background information (2)New coronavirus-infected pneumonia confirmed cases (including partial recovery cases), excluded cases, etc. (Confirmed cases should include patients with different disease processes (such as early, middle, late treatment / recovery patients, etc.) (3)Consecutive samples collected at different times from some patients with pneumonitis infected by the new coronavirus were included, including samples from each stage of the new coronavirus nucleic acid and antigen / antibody from negative to positive (4)The samples were selected as inpatients and outpatient patients for clinical needs.The remaining samples can be tested by clinical units or stored as frozen samples.

Exclusion criteria

Exclusion criteria: (1)Unclear sample collection time or information (2)Insufficient sample size due to mistakes in the test operation (3)Contaminated sample.

Design outcomes

Primary

MeasureTime frame
new coronavirus nucleocapsid (N) antigen;SEN, SPE, ACC, AUC of ROC;

Countries

China

Contacts

Public ContactZhang Chunyan

Chinese PLA General Hospital

rebrcca@126.com+86 18810882866

Outcome results

None listed

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