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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04981769

Enrollment

1000

Registered

2021-07-29

Start date

2021-08-02

Completion date

2021-11-30

Last updated

2021-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19

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.

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.

Interventions

DIAGNOSTIC_TESTCovid-19 test

PCR Covid-19 test

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

2 Years to 125 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Covid-19 PCR test result	90 minutes	Molecular Covid-19 testing

Contacts

Primary ContactMichael Blaivas, MD

mike.blaivas@anavasidx.com770-205-7721

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026