POC SARS-CoV-2 Diagnostic PCR Device Comparison to FDA Approved Reference PCR Test
- Conditions
- Covid19
- Interventions
- Diagnostic Test: Covid-19 test
- Registration Number
- NCT04981769
- Lead Sponsor
- Anavasi Diagnostics
- Brief Summary
Study will assess sensitivity and specificity of AnavasiDx POC PCR device for detection of Covid-19 in patients presenting for testing a clinical sites.
- Detailed Description
Study will assess sensitivity and specificity of AnavasiDx POC PCR device for detection of Covid-19 in patients presenting for testing a clinical sites using a national laboratory PCR Covid-19 test as reference. This study is following FDA EUA molecular test approval criteria. Study will be conducted in 3 or more geographically diverse clinical sites.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 1000
Inclusion Criteria
- Subjects presenting to clinical site for Covid-19 testing. Completion of signed written informed consent process.
Exclusion Criteria
- Inability to complete signed written informed consent process. Younger than 2 years of age. Any contraindication to Covid-19 swab testing
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients Covid-19 test Patients presenting to clinical sites for Covid-19 testing who are 2 years of age or older.
- Primary Outcome Measures
Name Time Method Covid-19 PCR test result 90 minutes Molecular Covid-19 testing
- Secondary Outcome Measures
Name Time Method