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

Anavasi Diagnostics

Status: Unknown

Conditions: Covid19

Treatments: Diagnostic Test: Covid-19 test

Study type: Observational

Funder types: Industry

Identifiers

NCT04981769

003

Details and patient eligibility

About

Study will assess sensitivity and specificity of AnavasiDx POC PCR device for detection of Covid-19 in patients presenting for testing a clinical sites.

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 2 to 125 years old

Volunteers: No Healthy Volunteers

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

Trial design

1,000 participants in 1 patient group

Patients

Description:

Patients presenting to clinical sites for Covid-19 testing who are 2 years of age or older.

Treatment:

Diagnostic Test: Covid-19 test