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

NCT ID: NCT04981769

Last Updated: 2021-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-02

Study Completion Date

2021-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Covid19

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients

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

Covid-19 test

Intervention Type DIAGNOSTIC_TEST

PCR Covid-19 test

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Covid-19 test

PCR Covid-19 test

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

2 Years

Maximum Eligible Age

125 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Anavasi Diagnostics

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Michael Blaivas, MD

Role: CONTACT

770-205-7721

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

003

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Communities Fighting COVID-19!
NCT05148936 COMPLETED NA
Role of Multiplex PCR in CAP
NCT06097117 UNKNOWN