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.
Age
2–125
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Subjects presenting to clinical site for Covid-19 testing. Completion of signed written informed consent process.
You may not be if
Inability to complete signed written informed consent process. Younger than 2 years of age. Any contraindication to Covid-19 swab testing