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

NCT05728970 | Completed FDA Device

• 1 other identifier: S-CLIN-PROT-00056
• Study Type: observational
• Target: 716
• Locations: 1 country
• Sites: 10

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.

Conditions

SARS-CoV-2; Influenza A; Influenza B; COVID-19

Keywords

LumiraDx; Diagnostic tests; Multiplex; SARS-CoV-2; Influenza A; Influenza B; COVID-19; Infections; Coronavirus; Lung disease

Outcome Measures

Primary Outcomes (2)

• Performance evaluation of the LumiraDx SARS-CoV-2 Ag Ultra by health care professionals

  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.

  6 months

• Performance evaluation by health care professionals

  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.

  6 months

Study Arms (1)

symptomatic

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

Diagnostic Test: LumiraDx SARS-CoV-2 Ag Ultra; Diagnostic Test: LumiraDx SARS-CoV-2 & Flu A/B

Interventions

LumiraDx SARS-CoV-2 Ag Ultra DIAGNOSTIC_TEST

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.

symptomatic

LumiraDx SARS-CoV-2 & Flu A/B DIAGNOSTIC_TEST

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.

symptomatic

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The entire population that met the inclusion criteria and none of the exclusion criteria. Symptomatic subjects will have symptoms suggestive of COVID-19 and/or Influenza.

You may qualify if:

• Subject may be of any age or sex.
• 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.
• Participant (or parent/legal guardian) capable and willing to give informed consent/assent.

You may not qualify if:

• The subject underwent a nasal wash/aspirate as part of standard of care testing during this study visit.
• 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.
• 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.
• 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.
• The subject previously participated in this study.

Sponsors & Collaborators

• LumiraDx UK Limited: lead

Study Sites (10)

Paragon Rx Clinical, Inc

Garden Grove, California, 92840, United States

Location

Torrance Clinical Research Institute Inc.

Lomita, California, 90717, United States

Location

Hillcrest Medical Research, LLC

DeLand, Florida, 32720, United States

Location

Hillcrest Medical Research

DeLand, Florida, 32720, United States

Location

Marisela Gonzalez MD PA

Miami, Florida, 33155, United States

Location

Barrett Clinic

La Vista, Nebraska, 68128, United States

Location

Meridian Clinical Research

Lincoln, Nebraska, 68510, United States

Location

Mercy Family Clinic

Dallas, Texas, 75211, United States

Location

Alliance for Multispecialty Research, LLC

Layton, Utah, 84041, United States

Location

Meridian Clinical Research, LLC. / Velocity Clinical Research

Hampton, Virginia, 23666, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Nasal and nasopharyngeal swab samples

MeSH Terms

Conditions

COVID-19; Infections; Coronavirus Infections; Lung Diseases

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2023
• First Posted: February 15, 2023
• Study Start: February 9, 2023
• Primary Completion: April 11, 2023
• Study Completion: April 11, 2023
• Last Updated: February 14, 2025

Record last verified: 2025-02

Locations

US (10)