Novel Coronavirus Pneumonia (COVID-19)
Conditions
Interventions
Gold Standard:Nucleic acid detection of nasopharyngeal swab samples of subjects
Index test:Antigen detection of nasal swab samples of subjects
Sponsors
Shenzhen Third People's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The expected applicable population, including different ages and genders; 2. Positive subjects include subjects with different viral loads (as determined by synchronous nucleic acid test results) and subjects with different times of onset of symptoms; 3. Negative subjects include those infected with other respiratory pathogens with suspected symptoms; 4. Subjects voluntarily participate and sign informed consent, or exempt informed consent after ethical review; 5. The subjects who need to conduct non-professional user testing in clinical trials should have no professional background related to medical or laboratory testing, have no experience in operating in vitro diagnostic reagents, meet the expected application scope of the product, and represent people of different ages, different education levels and different professional backgrounds. In particular, elderly people over 60 years old and subjects with junior high school or lower education level should account for a certain proportion.
Exclusion criteria
Exclusion criteria: 1. Sample collection and storage of unqualified samples; 2. Samples that cannot be tested due to contamination or other reasons; 3. Untraceable samples with incomplete information; 4. Other samples that do not meet requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Kappa value;Positive coincidence rate;Negative coincidence rate;Total coincidence rate; | — |
Countries
China
Contacts
Public ContactLu Shuihua
Shenzhen Third People's Hospital
Outcome results
None listed