Trials / Unknown
UnknownNCT04981769
POC SARS-CoV-2 Diagnostic PCR Device Comparison to FDA Approved Reference PCR Test
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,000 (estimated)
- Sponsor
- Anavasi Diagnostics · Industry
- Sex
- All
- Age
- 2 Years – 125 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | Covid-19 test | PCR Covid-19 test |
Timeline
- Start date
- 2021-08-02
- Primary completion
- 2021-09-30
- Completion
- 2021-11-30
- First posted
- 2021-07-29
- Last updated
- 2021-07-29
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04981769. Inclusion in this directory is not an endorsement.