POC SARS-CoV-2 Diagnostic PCR Device Comparison to FDA Approved Reference PCR Test

POC SARS-CoV-2 Diagnostic PCR Device Comparison to FDA Approved Reference PCR Test

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.

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