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A Clinical Evaluation of Proof Diagnostics Test System Including the Proof Diagnostics Reader and COVID-19 Test

NCT05331976 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 276

Last updated 2022-04-25

No results posted yet for this study

Summary

To determine the accuracy of Proof Diagnostics COVID-19 Test in the intended, symptomatic and suspected/at-risk asymptomatic population and point-of-care use as compared to a standard molecular comparator, Quidel Lyra SARS-CoV-2 Assay for diagnosing SARS-CoV-2 infection.

Conditions

Interventions

DIAGNOSTIC_TEST

Proof Lab Test System

Includes the Proof Lab Reader and the Proof Lab COVID-19 Test Kit containing: Proof Lab COVID-19 Test Cartridge, Sample Vial, Sample Swab, Exact Volume Transfer Pipette

Sponsors & Collaborators

  • ICON Clinical Research

    collaborator INDUSTRY

  • MRI Global

    collaborator INDUSTRY

  • ASCLEPES Research Center

    collaborator UNKNOWN

  • Eastside Research Associates

    collaborator UNKNOWN

  • PMG Research of Piedmont Healthcare

    collaborator UNKNOWN

  • Proof Diagnostics

    lead INDUSTRY

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-09
Primary Completion
2022-03-21
Completion
2022-03-21

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05331976 on ClinicalTrials.gov