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Performance Evaluation of LumiraDx COVID-19 (SARS-CoV-2) Ag ULTRA Test (ASPIRE-2)

NCT05506618 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2023-03-13

No results posted yet for this study

Summary

Performance of the LumiraDx SARS-CoV-2 Ag ULTRA assay will be assessed by comparison to a reference method

Conditions

Interventions

DIAGNOSTIC_TEST

Nasal Swab

Collection of one more nasal swabs

DIAGNOSTIC_TEST

Nasopharyngeal swab

Collection of one more nasopharyngeal swabs

Sponsors & Collaborators

  • LumiraDx UK Limited

    lead INDUSTRY

Principal Investigators

  • Christine Girgis, MD · Advanced Investigative Medicine

  • Michael Vaughn, MD · Cahaba Research, Inc.

  • Frank Calcagno, MD · Cyn3rgy Research

  • Hilda Brito, MD · Healthy Life Research, Inc.

  • Rogelio Machuca, MD · The Machuca Foundation, Inc.

  • Tewodros Teketel, MD · Zion Urgent Care

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-30
Primary Completion
2022-10-04
Completion
2023-04-30
FDA Device
Yes

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 NCT05506618 on ClinicalTrials.gov