Study will assess sensitivity and specificity of AnavasiDx POC PCR device for detection of Covid-19 in patients presenting for testing a clinical sites.
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.
Diagnostic Test: Covid-19 test
PCR Covid-19 test
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
Michael Blaivas, MD
770-205-7721
mike.blaivas@anavasidx.com