Respiratory viruses (with SARS-CoV-2 as a representative)
Conditions
Interventions
Gold Standard:Taking the antigen test strips and clinical qRT-PCR results as the reference standards
Index test:1. Detection method: Time-current method (i-t Chronoamperometry)
2. Biological marker/identification element: Angiotensin-converting enzyme 2 (ACE2) receptor3. Integrated device platform: Electrochemical sensing detection method for exhaled breath condensate based
Sponsors
The Seventh Affiliated Hospital Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
4 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1.Group A (Healthy Volunteers): Age range 4 - 70 years old; Self-perceived in good health condition, without acute respiratory symptoms such as fever, cough, or sore throat; After being evaluated by the doctors of the research team, it was confirmed that there were no current signs of infection; And on the day of enrollment for sampling, the rapid test result for the novel coronavirus provided by the research group was negative. 2.Group B (patients with respiratory tract infections): Age range 4 - 70 years; newly diagnosed with respiratory tract infection through routine clinical tests (such as qRT-PCR nucleic acid testing or multiplex PCR testing). This group aims to comprehensively evaluate the detection performance of the EBCatch system, particularly its specificity for the novel coronavirus. Therefore, it will include the following two types of patients: B1 group: Patients with novel coronavirus (SARS-CoV-2) infection: To assess the sensitivity of the EBCatch system for the target virus. They can be further divided into symptomatic and asymptomatic subgroups based on symptoms. Group B2: Other respiratory virus infections: Individuals who have been confirmed to be infected with non-SARS-CoV-2 respiratory viruses (such as influenza virus, respiratory syncytial virus, adenovirus, etc.). This group serves as a crucial negative control group, used to evaluate the specificity of the EBCatch system in excluding other common respiratory virus infections.
Exclusion criteria
Exclusion criteria: 1.Suffering from severe chronic respiratory diseases (such as severe asthma, chronic obstructive pulmonary disease), and having been assessed as unable to cooperate in completing exhalation sampling; 2.the condition is critical and requires immediate emergency medical intervention; 3.there are any situations that, in the judgment of the researchers, may affect their cooperation in the study or may pose additional risks for them due to participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diagnostic sensitivity;specificity; | — |
Countries
China
Contacts
Public ContactYuzhi Xu
The Seventh Affiliated Hospital Sun Yat-sen University
Outcome results
None listed