Performance Evaluation of the LumiraDX SARS-CoV-2 Ag Ultra and LumiraDX SARS-CoV-2 & Flu A/B Tests At Point of Care (POC) Sites

Completed

• Conditions: Influenza a; COVID-19; SARS-CoV-2; Influenza B
• Interventions: Diagnostic Test: LumiraDx SARS-CoV-2 Ag Ultra; Diagnostic Test: LumiraDx SARS-CoV-2 & Flu A/B

• Registration Number: NCT05728970
• Lead Sponsor: LumiraDx UK Limited

Brief 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.

Detailed Description

Approximately two thousand (2000) subjects will be enrolled in this study. Patients presenting to the study sites that meet the eligibility criteria will be considered for the study.

A subject's participation in this study will consist of a single on-site visit. Following completion of the informed consent process and a review of inclusion/exclusion criteria to determine eligibility, each subject will receive a unique study identification number.

Specimens will be obtained from each subject enrolled using standard collection methods.

The objectives of this study are to evaluate and validate the performance of:

* LumiraDx SARS-CoV-2 Ag Ultra test in detecting SARS-CoV-2 from symptomatic patients as compared with a Food and Drug Administration (FDA) cleared reverse transcription-polymerase chain reaction (RT-PCR) test.

* LumiraDx SARS-CoV-2 \& Flu A/B tests in detecting SARS-CoV-2, Flu A, and/or Flu B from symptomatic patients as compared with an FDA cleared RT-PCR test for SARS-CoV-2 and an FDA cleared RT-PCR test for Flu A and Flu B.

Study Timeline

• Study First Submitted: 2023-02-06
• Study First Submitted QC: 2023-02-06
• Study Start: 2023-02-09
• Study First Posted: 2023-02-15
• Primary Completion: 2023-04-11
• Study Completion: 2023-04-11
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-12
• Last Update Posted: 2025-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 716

Inclusion Criteria

1. Subject may be of any age or sex.
2. Self-reported symptoms by the subject and/or preliminary assessment of the subject by the Investigator/designee should be suggestive of COVID-19 and/or Influenza at the time of the study visit. The subject must present as symptomatic, exhibiting one or more of the following signs and symptoms: fever, cough, shortness of breath, difficulty breathing, muscle pain, headache, sore throat, chills, repeated shaking with chills, new loss of taste or smell congestion or runny nose, diarrhea, nausea or vomiting. The onset of these symptoms will be recorded and will be within the last twelve (12) days.
3. Participant (or parent/legal guardian) capable and willing to give informed consent/assent.

Exclusion Criteria

1. The subject underwent a nasal wash/aspirate as part of standard of care testing during this study visit.
2. The subject is currently receiving or has received within the past thirty (30) days of the study visit an experimental biologic, drug, or device including either treatment or therapy.
3. Subjects undergoing treatment currently and/or within the past thirty (30) days of the study with medication to treat novel Coronavirus SARS-CoV-2 viral infections, which may include but is not limited to; COVID-19 antivirals (Lagevrio, PAXLOVID), Remdesivir (Veklury) or receiving convalescent plasma therapy for SARS-CoV-2.
4. Subjects undergoing treatment currently and/or within the past fourteen (14) days of the study visit with an inhaled influenza vaccine (FluMist®) or with anti-viral medication, which may include but is not limited to Amantadine (Symmetrel®), Rimantadine (Flumadine®), Zanamivir (Relenza®), Oseltamivir (Tamiflu®), Baloxavir Marboxil (Xofluza™), Palivizumab (Synagis®), or ribavirin.
5. The subject previously participated in this study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
symptomatic	LumiraDx SARS-CoV-2 Ag Ultra	Self-reported symptoms by the subject and/or preliminary assessment of the subject by the Investigator/designee should be suggestive of COVID-19 and/or Influenza at the time of the study visit. The subject must present as symptomatic, exhibiting one or more of the following signs and symptoms: fever, cough, shortness of breath, difficulty breathing, muscle pain, headache, sore throat, chills, repeated shaking with chills, new loss of taste or smell congestion or runny nose, diarrhea, nausea or vomiting. The onset of these symptoms will be recorded and will be within the last twelve (12) days
symptomatic	LumiraDx SARS-CoV-2 & Flu A/B	Self-reported symptoms by the subject and/or preliminary assessment of the subject by the Investigator/designee should be suggestive of COVID-19 and/or Influenza at the time of the study visit. The subject must present as symptomatic, exhibiting one or more of the following signs and symptoms: fever, cough, shortness of breath, difficulty breathing, muscle pain, headache, sore throat, chills, repeated shaking with chills, new loss of taste or smell congestion or runny nose, diarrhea, nausea or vomiting. The onset of these symptoms will be recorded and will be within the last twelve (12) days

Primary Outcome Measures

Name	Time	Method
Performance evaluation of the LumiraDx SARS-CoV-2 Ag Ultra by health care professionals	6 months	Evaluate the performance of the LumiraDx SARS-CoV-2 Ag Ultra test in detecting SARS-CoV-2 in fresh nasal swab specimens from symptomatic patients. Performance will be evaluated by use of statistical analysis techniques to assess sensitivity (true positive rate), specificity (true negative rate), Negative and Positive Percent Agreement (NPA, PPA) of the LumiraDx test results versus an FDA-approved method where a result of 100% sensitivity, specificity, NPA or PPA would equate to complete agreement with the reference method and 0% would equate to no agreement.
Performance evaluation by health care professionals	6 months	Evaluate the performance of the LumiraDx SARS-CoV-2 \& Flu A/B test in detecting and differentiating SARS-CoV-2, influenza A and influenza B in fresh nasal swab specimens from symptomatic patients. Performance will be evaluated by use of statistical analysis techniques to assess sensitivity (true positive rate), specificity (true negative rate), Negative and Positive Percent Agreement (NPA, PPA) of the LumiraDx test results versus an FDA-approved method where a result of 100% sensitivity, specificity, NPA or PPA would equate to complete agreement with the reference method and 0% would equate to no agreement.

Trial Locations

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