Clinical Performance Verification Study of "COVID-19 Ag Rapid Saliva Test Device" for Diagnostic Aid of SARS-CoV-2 Infectio
Not Applicable
- Conditions
- COVID-19
- Registration Number
- JPRN-UMIN000049723
- Lead Sponsor
- BIC GROUP Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 120
Inclusion Criteria
Not provided
Exclusion Criteria
Patients with symptoms for more than ten days. Patients with an invalid test result. Patients who could not collect saliva needed for testing.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Positive percent agreement, Negative percent agreement and Overall percent agreement are all not lower than 90 percent.
- Secondary Outcome Measures
Name Time Method