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NCT04981769 Clinical Trial

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

Covid19 Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04981769
Other study ID # 003
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date August 2, 2021
Est. completion date November 30, 2021

Study information
Verified date July 2021
Source Anavasi Diagnostics
Contact Michael Blaivas, MD
Phone 770-205-7721
Email mike.blaivas@anavasidx.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 1000
Est. completion date November 30, 2021
Est. primary completion date September 30, 2021
Accepts healthy volunteers No
Gender All
Age group 2 Years to 125 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Covid-19 test
PCR Covid-19 test

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Anavasi Diagnostics

Outcome
Type Measure Description Time frame Safety issue
Primary Covid-19 PCR test result Molecular Covid-19 testing 90 minutes
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