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POC Performance Evaluation of LumiraDx SARS-CoV-2 Ag Ultra and SARS-CoV-2 & Flu A/B Tests.
Sponsor: LumiraDx UK Limited
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
Conditions
Interventions
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.
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