COVID-19INSPIRE-2NCT05268939
Performance Evaluation of LumiraDx SARS-CoV-2, Flu A/B, and RSV Tests for COVID-19 Assessment
An observational study of COVID-19 and Influenza A, run by LumiraDx UK Limited at 8 sites in United States.
Trial summary
A Multicenter Study Conducted to Evaluate the Performance of the LumiraDx SARS-CoV-2 \& FLU A/B Test, and LumiraDx SARS-CoV-2 \& RSV Test at Point of Care Testing Sites. Subjects presenting with symptoms suggestive of COVID-19 and/or Influenza and/or RSV will be consented and asked to donate swab sample(s) for testing… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COVID-19, Influenza A, Influenza Type B
- What is being tested?
- LumiraDx SARS-CoV-2 & Flu A/B test and LumiraDx SARS-CoV-2 & RSV test
- How many people
- 589 participants
- Where
- 8 sitesUnited States
- Study dates
- 4 Jan 2022to 14 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The subject may be of any age and either sex. Subjects must qualify for either the COVID-19 or Influenza/RSV cohort based on strict clinical timelines. The COVID cohort requires characteristic symptoms starting within the last 12 days, or respiratory symptoms with a positive SARS-CoV-2 test from the past 48 hours. Alternatively, the Influenza/RSV cohort requires a recent fever of 100.0°F or higher alongside at least two systemic symptoms starting within the last 4 days. Finally, individuals can also qualify for the Influenza/RSV branch if they present with respiratory symptoms and a documented positive Flu or RSV test from the preceding 48 hours.
Who may be able to join
- Preliminary assessment of the subject by the Investigator/designee should be suggestive of COVID-19 and /or influenza and/or RSV at the time of the study visit.
- The subject must present in one of the following two cohorts:
- Covid Cohort:
- Preliminary assessment of the subject by the Investigator/designee should be suggestive of COVID-19 at the time of the study visit. The subject must present as symptomatic, meaning they have exhibited one or more of the following signs and symptoms for eligibility: 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 in the last twelve (12) days.
- or The subject must have presented with respiratory symptoms and a documented positive SARS-CoV-2 PCR or antigen test in the past forty-eight (48) hours.
- Influenza/RSV Cohort:
- The subject must have a fever of 100.0 °F or greater with the onset of the fever being within the past three (3) days and/or present at the time of the visit. Fever can be reported or taken at time of visit. Subjects must report having a fever, but a quantitative reported measurement is not necessary for inclusion. In addition to the fever, the subject must have two (2) or more of the following signs and symptoms for eligibility: cough, shortness of breath, difficulty breathing, muscle pain, joint pain, headache, chills, repeated shaking with chills, congestion or runny nose, diarrhea, nausea, vomiting, sneezing, sore throat, wheezing, fatigue, weakness and/or malaise or anorexia. The onset of these symptoms will be recorded and will be in the last four (4) days. OR The subject must have presented with respiratory symptoms and a documented positive Flu or RSV test in the past forty-eight (48) hours.
- Written informed consent must be obtained prior to study enrollment. A subject who is a legal adult must be willing to give written informed consent and must agree to comply with study procedures. The Legal Guardian or Legal Authorized Representative of a subject who is under the age of consent must give written informed consent and agree to comply with study procedures. Active assent should be obtained from children of appropriate intellectual age (as defined by the IRB)
Who cannot join
- The subject underwent a nasal wash/aspirate as part of standard of care testing during this study visit.
- Subjects undergoing treatment currently and/or within the past fourteen (14 days of the study visit with an inhaled influenza vaccine (FluMist®) or with antiviral medication, which may include but is not limited to Amantadine (Symmetrel®), Rimantadine (Flumadine®), Zanamivir (Relenza®), Oseltamivir (Tamiflu®), or Baloxavir Marboxil (Xofluza™)
- Subjects undergoing treatment currently and/or within the past thirty (30) days of the study with prescription medication to treat novel Coronavirus SARS-CoV-2 infection, which may include but is not limited to Remdesivir (Veklury) or receiving convalescent plasma therapy for SARS-CoV-2;
- The subject is undergoing treatment currently or had undergone within the past fourteen (14) days of the study visit with RSV-related medication which may include but is not limited to Ribavirin (Virazole), RSV-IGIV (RespiGam) or palivizumab (Synagis).
- 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.
- The subject has previously participated in this research study (CS-1262-01).
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Benchmark Research
Covington, Louisiana, 70433
Cullman Clinical Trials
Cullman, Alabama, 35055
Diagnamics, Inc
Encinitas, California, 92024
Machuca Foundation
Las Vegas, Nevada, 89104
Marisela Gonzalez, MD, PA
Miami, Florida, 33155
Excellence Medical and Research
Miami Gardens, Florida, 33169
Clinical Research Solutions
Middleburg Heights, Ohio, 44130
Koch Family Medicine
Morton, Illinois, 61550
About this study
Official title: A Multicenter Study Conducted to Evaluate the Performance of the LumiraDx SARS-CoV-2 & FLU A/B Test, and LumiraDx SARS-CoV-2 & RSV Test at Point of Care Testing Sites
A Multicenter Study Conducted to Evaluate the Performance of the LumiraDx SARS-CoV-2 \& FLU A/B Test, and LumiraDx SARS-CoV-2 \& RSV Test at Point of Care Testing Sites. Subjects presenting with symptoms suggestive of COVID-19 and/or Influenza and/or RSV will be consented and asked to donate swab sample(s) for testing in the device(s) under evaluation.
Read the detailed description
Approximately one-thousand (1000) subjects will be enrolled in this study. Patients presenting to their health care professionals, drive through testing sites or research centers and meet the inclusion/exclusion criteria will be enrolled in the study.
A subject's participation in this study will consist of a single 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.
The potential subject will be asked to provide relevant medical history information (i.e., regarding their influenza/RSV and or COVID-19-like symptoms), which will be evaluated against all inclusion and exclusion criteria depending in their cohort. A subject's SARS-CoV-2 vaccination status will also be collected including the doses, dates of vaccination and brand.
Specimens will be obtained from each subject enrolled using standard collection methods.
The objectives of this study are to:
- Evaluate the performance of the LumiraDx SARS-CoV-2 \& Flu A/B Test in detecting SARS-CoV-2 and/ or influenza A or B in nasal and nasopharyngeal swabs from patients with signs and symptoms of COVID-19 or influenza as compared with an FDA EUA authorized or 510(k) comparative method.
- Evaluate the performance of the LumiraDx SARS-CoV-2 \& RSV Test in detecting SARS-CoV-2 and/ or RSV in nasal and nasopharyngeal swabs from patients with signs and symptoms of COVID-19 or RSV as compared with an FDA EUA authorized or 510(k) comparative method.
- Evaluate the point of care usability of the LumiraDx SARS-CoV-2 \& Flu A/B Test and LumiraDx SARS-CoV-2 \& RSV Test.
- Conditions
- COVID-19, Influenza A, Influenza Type B, RSV Infection
- Being tested
- LumiraDx SARS-CoV-2 & Flu A/B test, LumiraDx SARS-CoV-2 & RSV test
- Medical subject headings
- COVID-19, Respiratory Syncytial Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LumiraDx SARS-CoV-2 & Flu A/B testDiagnostic test
Swab Samples for Diagnostic test
LumiraDx SARS-CoV-2 & RSV testDiagnostic test
Swab Samples for Diagnostic test
| Study group | Role | What they receive |
|---|---|---|
| Nasal Swab | Nasal swab from subjects with signs and symptoms of COVID-19 and/or Influenza and/or RSV-like illness Receives: Diagnostic Test: LumiraDx SARS-CoV-2 & Flu A/B test; Diagnostic Test: LumiraDx SARS-CoV-2 & RSV test | |
| Nasopharyngeal Swab | Nasopharyngeal swab from subjects with signs and symptoms of COVID-19 and/or Influenza and/or RSV-like illness Receives: Diagnostic Test: LumiraDx SARS-CoV-2 & Flu A/B test; Diagnostic Test: LumiraDx SARS-CoV-2 & RSV test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance evaluation by health care professionals
Evaluate the performance of the LumiraDx Tests in detecting and differentiating SARS-CoV-2, influenza A, influenza B and/or RSV in fresh nasal or nasopharyngeal swab specimens from patients with signs and symptoms of COVID-19, Influenza and/or RSV-like illness. 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.
Measured: 4 months
Point of Care usability
Evaluate the point of care usability of the LumiraDx SARS-CoV-2 \& Flu A/B Test and LumiraDx SARS-CoV-2 \& RSV Tests. Usability will be assessed by means of a user questionnaire to be completed by naive users following their first test of the devices using standard Pack Leaflet and Quick Reference Instructions.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2022
- Study start4 Jan 2022
- Primary completion25 Apr 2022
- Study completion14 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 589 participants (actual)
Sponsor and investigators
- Lead sponsor
- LumiraDx UK Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ramin Farsad, Principal investigator, Diagnamics, IncSherri Casey, Principal investigator, Benchmark ResearchJustin Wilson, Principal investigator, Cullman Clinical TrialsMiguel Perez, Principal investigator, Excellence Medical and ResearchMary Imig, Principal investigator, Koch Family MedicineMarisela Gonzalez, Principal investigator, Marisela Gonzalez, MD, PALawrence Gervasi, Principal investigator, Clinical Research SolutionsRogelio Machuca, Principal investigator, Machuca Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05268939
- Sponsor's protocol ID
- S-CLIN-PROT-00034
- Acronym
- INSPIRE-2
- Status last verified
- Jun 2026
- First submitted
- 3 Mar 2022
- Last updated
- 15 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Study Conducted to Evaluate the Performance of the LumiraDx SARS-CoV-2 & FLU A/B Test, and LumiraDx SARS-CoV-2 & RSV Test at Point of Care Testing Sites
- ClinicalTrials.gov ID
- NCT05268939
- Acronym / sponsor ID
- INSPIRE-2 / S-CLIN-PROT-00034
- Conditions
- COVID-19, Influenza A, Influenza Type B, RSV Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 589 participants (actual)
- Lead sponsor
- LumiraDx UK LimitedIndustry (pharma, biotech, devices)
- Study start
- 4 Jan 2022 (actual)
- Primary completion
- 25 Apr 2022 (actual)
- Study completion
- 14 Mar 2023 (actual)
- First posted
- 7 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Multicenter Study Conducted to Evaluate the Performance of the LumiraDx SARS-CoV-2 \& FLU A/B Test, and LumiraDx SARS-CoV-2 \& RSV Test at Point of Care Testing Sites. Subjects presenting with symptoms suggestive of COVID-19 and/or Influenza and/or RSV will be consented and asked to donate swab sample(s) for testing in the device(s) under evaluation.
Detailed description
Approximately one-thousand (1000) subjects will be enrolled in this study. Patients presenting to their health care professionals, drive through testing sites or research centers and meet the inclusion/exclusion criteria will be enrolled in the study.
A subject's participation in this study will consist of a single 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.
The potential subject will be asked to provide relevant medical history information (i.e., regarding their influenza/RSV and or COVID-19-like symptoms), which will be evaluated against all inclusion and exclusion criteria depending in their cohort. A subject's SARS-CoV-2 vaccination status will also be collected including the doses, dates of vaccination and brand.
Specimens will be obtained from each subject enrolled using standard collection methods.
The objectives of this study are to:
- Evaluate the performance of the LumiraDx SARS-CoV-2 \& Flu A/B Test in detecting SARS-CoV-2 and/ or influenza A or B in nasal and nasopharyngeal swabs from patients with signs and symptoms of COVID-19 or influenza as compared with an FDA EUA authorized or 510(k) comparative method.
- Evaluate the performance of the LumiraDx SARS-CoV-2 \& RSV Test in detecting SARS-CoV-2 and/ or RSV in nasal and nasopharyngeal swabs from patients with signs and symptoms of COVID-19 or RSV as compared with an FDA EUA authorized or 510(k) comparative method.
- Evaluate the point of care usability of the LumiraDx SARS-CoV-2 \& Flu A/B Test and LumiraDx SARS-CoV-2 \& RSV Test.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nasal Swab | – | Diagnostic Test: LumiraDx SARS-CoV-2 & Flu A/B test, Diagnostic Test: LumiraDx SARS-CoV-2 & RSV testNasal swab from subjects with signs and symptoms of COVID-19 and/or Influenza and/or RSV-like illness |
| Nasopharyngeal Swab | – | Diagnostic Test: LumiraDx SARS-CoV-2 & Flu A/B test, Diagnostic Test: LumiraDx SARS-CoV-2 & RSV testNasopharyngeal swab from subjects with signs and symptoms of COVID-19 and/or Influenza and/or RSV-like illness |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The subject may be of any age and either sex. Subjects must qualify for either the COVID-19 or Influenza/RSV cohort based on strict clinical timelines. The COVID cohort requires characteristic symptoms starting within the last 12 days, or respiratory symptoms with a positive SARS-CoV-2 test from the past 48 hours. Alternatively, the Influenza/RSV cohort requires a recent fever of 100.0°F or higher alongside at least two systemic symptoms starting within the last 4 days. Finally, individuals can also qualify for the Influenza/RSV branch if they present with respiratory symptoms and a documented positive Flu or RSV test from the preceding 48 hours.
Key inclusion criteria (8 listed)
- Preliminary assessment of the subject by the Investigator/designee should be suggestive of COVID-19 and /or influenza and/or RSV at the time of the study visit.
- The subject must present in one of the following two cohorts:
- Preliminary assessment of the subject by the Investigator/designee should be suggestive of COVID-19 at the time of the study visit. The subject must present as symptomatic, meaning they have exhibited one or more of the following signs and symptoms for eligibility: 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 in the last twelve (12) days.
- or The subject must have presented with respiratory symptoms and a documented positive SARS-CoV-2 PCR or antigen test in the past forty-eight (48) hours.
- The subject must have a fever of 100.0 °F or greater with the onset of the fever being within the past three (3) days and/or present at the time of the visit. Fever can be reported or taken at time of visit. Subjects must report having a fever, but a quantitative reported measurement is not necessary for inclusion. In addition to the fever, the subject must have two (2) or more of the following signs and symptoms for eligibility: cough, shortness of breath, difficulty breathing, muscle pain, joint pain, headache, chills, repeated shaking with chills, congestion or runny nose, diarrhea, nausea, vomiting, sneezing, sore throat, wheezing, fatigue, weakness and/or malaise or anorexia. The onset of these symptoms will be recorded and will be in the last four (4) days. OR The subject must have presented with respiratory symptoms and a documented positive Flu or RSV test in the past forty-eight (48) hours.
Key exclusion criteria (6 listed)
- The subject underwent a nasal wash/aspirate as part of standard of care testing during this study visit.
- Subjects undergoing treatment currently and/or within the past fourteen (14 days of the study visit with an inhaled influenza vaccine (FluMist®) or with antiviral medication, which may include but is not limited to Amantadine (Symmetrel®), Rimantadine (Flumadine®), Zanamivir (Relenza®), Oseltamivir (Tamiflu®), or Baloxavir Marboxil (Xofluza™)
- Subjects undergoing treatment currently and/or within the past thirty (30) days of the study with prescription medication to treat novel Coronavirus SARS-CoV-2 infection, which may include but is not limited to Remdesivir (Veklury) or receiving convalescent plasma therapy for SARS-CoV-2;
- The subject is undergoing treatment currently or had undergone within the past fourteen (14) days of the study visit with RSV-related medication which may include but is not limited to Ribavirin (Virazole), RSV-IGIV (RespiGam) or palivizumab (Synagis).
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LumiraDx SARS-CoV-2 & Flu A/B testSwab Samples for Diagnostic test | Diagnostic test | Nasal Swab, Nasopharyngeal Swab |
| LumiraDx SARS-CoV-2 & RSV testSwab Samples for Diagnostic test | Diagnostic test | Nasal Swab, Nasopharyngeal Swab |
Primary outcome
Performance evaluation by health care professionals
Time frame: 4 months
Evaluate the performance of the LumiraDx Tests in detecting and differentiating SARS-CoV-2, influenza A, influenza B and/or RSV in fresh nasal or nasopharyngeal swab specimens from patients with signs and symptoms of COVID-19, Influenza and/or RSV-like illness. 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.
Point of Care usability
Time frame: 4 months
Evaluate the point of care usability of the LumiraDx SARS-CoV-2 \& Flu A/B Test and LumiraDx SARS-CoV-2 \& RSV Tests. Usability will be assessed by means of a user questionnaire to be completed by naive users following their first test of the devices using standard Pack Leaflet and Quick Reference Instructions.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ramin Farsad principal investigator
Diagnamics, Inc
Sherri Casey principal investigator
Benchmark Research
Justin Wilson principal investigator
Cullman Clinical Trials
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and Influenza A, run by LumiraDx UK Limited at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance evaluation by health care professionals (time frame: 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.