Clinical trial NCT05728970: 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
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: LumiraDx UK Limited
Sponsor class: INDUSTRY
First posted: 2023-02-15
Enrollment: 716
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Performance evaluation of the LumiraDx SARS-CoV-2 Ag Ultra by health care professionals
timeFrame: 6 months
measure: Performance evaluation by health care professionals
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Garden Grove
country: United States
facility: Paragon Rx Clinical, Inc
state: California
city: Lomita
country: United States
facility: Torrance Clinical Research Institute Inc.
state: California
city: DeLand
country: United States
facility: Hillcrest Medical Research, LLC
state: Florida
city: DeLand
country: United States
facility: Hillcrest Medical Research
state: Florida
city: Miami
country: United States
facility: Marisela Gonzalez MD PA
state: Florida
city: La Vista
country: United States
facility: Barrett Clinic
state: Nebraska
city: Lincoln
country: United States
facility: Meridian Clinical Research
state: Nebraska
city: Dallas
country: United States
facility: Mercy Family Clinic
state: Texas
city: Layton
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Utah
city: Hampton
country: United States
facility: Meridian Clinical Research, LLC. / Velocity Clinical Research
state: Virginia
Study officials:
References: