POC SARS-CoV-2 Diagnostic PCR Device Comparison to FDA Approved Reference PCR Test
Sponsor
Anavasi Diagnostics (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT04981769
Collaborator
(none)
1,000
3.9
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Study Type:
Observational
Anticipated Enrollment
:
1000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
POC SARS-CoV-2 Diagnostic PCR Device Comparison to FDA Approved Reference PCR Test
Anticipated Study Start Date
:
Aug 2, 2021
Anticipated Primary Completion Date
:
Sep 30, 2021
Anticipated Study Completion Date
:
Nov 30, 2021
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Patients Patients presenting to clinical sites for Covid-19 testing who are 2 years of age or older. |
Diagnostic Test: Covid-19 test
PCR Covid-19 test
|
Outcome Measures
Primary Outcome Measures
- Covid-19 PCR test result [90 minutes]
Molecular Covid-19 testing
Eligibility Criteria
Criteria
Ages Eligible for Study:
2 Years
to 125 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Anavasi Diagnostics
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Anavasi Diagnostics
ClinicalTrials.gov Identifier:
NCT04981769
Other Study ID Numbers:
- 003
First Posted:
Jul 29, 2021
Last Update Posted:
Jul 29, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No