Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
COMPLETED
NCT05728970

POC Performance Evaluation of LumiraDx SARS-CoV-2 Ag Ultra and SARS-CoV-2 & Flu A/B Tests.

Sponsor: LumiraDx UK Limited

View on ClinicalTrials.gov

Summary

This is a prospective multicenter study conducted to evaluate the performance of the LumiraDx SARS-CoV-2 Ag Ultra test in detecting severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and LumiraDx SARS-CoV-2 \& Flu A/B test in differential detection of SARS-CoV-2, Influenza A (Flu A) and Influenza B (Flu B) at point of care sites. Subjects presenting with symptoms suggestive of coronavirus disease 2019 (COVID-19) and/or Influenza at the time of the study visit will be enrolled and asked to donate swab sample(s) for testing in the device(s) under evaluation.

Official title: A Prospective Multicenter Study Conducted to Evaluate the Performance of the LumiraDX SARS-CoV-2 Ag Ultra and LumiraDX SARS-CoV-2 & Flu A/B Tests at Point of Care Sites

Key Details

Gender

All

Age Range

Any - Any

Study Type

OBSERVATIONAL

Enrollment

716

Start Date

2023-02-09

Completion Date

2023-04-11

Last Updated

2026-06-12

Healthy Volunteers

Yes

Interventions

DIAGNOSTIC_TEST

LumiraDx SARS-CoV-2 Ag Ultra

The LumiraDx SARS-CoV-2 Ag Ultra Test is an automated rapid microfluidic immunofluorescence assay for use with the LumiraDx Platform intended for the qualitative detection of the nucleocapsid protein antigen to SARS-CoV-2 directly from anterior nasal swab samples collected from symptomatic individuals within the first twelve days of symptom onset suspected of COVID-19 by their healthcare provider.

DIAGNOSTIC_TEST

LumiraDx SARS-CoV-2 & Flu A/B

The LumiraDx SARS-CoV-2 \& Flu A/B test is an automated rapid microfluidic immunofluorescence assay for use with the LumiraDx Platform, for near-patient testing, intended for the qualitative detection and differentiation of SARS-CoV-2, Influenza A and/or Influenza B viral antigens from nasal swab samples.

Locations (10)

Paragon Rx Clinical, Inc

Garden Grove, California, United States

Torrance Clinical Research Institute Inc.

Lomita, California, United States

Hillcrest Medical Research, LLC

DeLand, Florida, United States

Hillcrest Medical Research

DeLand, Florida, United States

Marisela Gonzalez MD PA

Miami, Florida, United States

Barrett Clinic

La Vista, Nebraska, United States

Meridian Clinical Research

Lincoln, Nebraska, United States

Mercy Family Clinic

Dallas, Texas, United States

Alliance for Multispecialty Research, LLC

Layton, Utah, United States

Meridian Clinical Research, LLC. / Velocity Clinical Research

Hampton, Virginia, United States