SARS-CoV-2PURSUENCT05728970
POC Performance Evaluation of LumiraDx SARS-CoV-2 Ag Ultra and SARS-CoV-2 & Flu A/B Tests.
An observational study of SARS-CoV-2 and Influenza A, run by LumiraDx UK Limited at 10 sites in United States.
Trial 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)… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV-2, Influenza A, Influenza B
- What is being tested?
- LumiraDx SARS-CoV-2 Ag Ultra and LumiraDx SARS-CoV-2 & Flu A/B
- How many people
- 716 participants
- Where
- 10 sitesUnited States
- Study dates
- 9 Feb 2023to 11 Apr 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
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Mercy Family Clinic
Dallas, Texas, 75211
Hillcrest Medical Research, LLC
DeLand, Florida, 32720
Hillcrest Medical Research
DeLand, Florida, 32720
Paragon Rx Clinical, Inc
Garden Grove, California, 92840
Meridian Clinical Research, LLC. / Velocity Clinical Research
Hampton, Virginia, 23666
Barrett Clinic
La Vista, Nebraska, 68128
Alliance for Multispecialty Research, LLC
Layton, Utah, 84041
Meridian Clinical Research
Lincoln, Nebraska, 68510
Torrance Clinical Research Institute Inc.
Lomita, California, 90717
Marisela Gonzalez MD PA
Miami, Florida, 33155
About this study
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
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.
Read the 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.
- Conditions
- SARS-CoV-2, Influenza A, Influenza B, COVID-19
- Being tested
- LumiraDx SARS-CoV-2 Ag Ultra, LumiraDx SARS-CoV-2 & Flu A/B
- Keywords
- LumiraDx, Diagnostic tests, Multiplex, SARS-CoV-2, Influenza A, Influenza B, COVID-19, Infections, Coronavirus, Lung disease
- Medical subject headings
- COVID-19, Infections, Coronavirus Infections, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LumiraDx SARS-CoV-2 Ag UltraDiagnostic 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.
LumiraDx SARS-CoV-2 & Flu A/BDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: LumiraDx SARS-CoV-2 Ag Ultra; Diagnostic Test: LumiraDx SARS-CoV-2 & Flu A/B |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start9 Feb 2023
- Primary completion11 Apr 2023
- Study completion11 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV-2Studies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 716 participants (actual)
Sponsor and investigators
- Lead sponsor
- LumiraDx UK Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Brian DuChateau, PhD, Study director, LumiraDx
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05728970
- Sponsor's protocol ID
- S-CLIN-PROT-00056
- Acronym
- PURSUE
- Status last verified
- Jun 2026
- First submitted
- 6 Feb 2023
- Last updated
- 12 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05728970
- Acronym / sponsor ID
- PURSUE / S-CLIN-PROT-00056
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 716 participants (actual)
- Lead sponsor
- LumiraDx UK LimitedIndustry (pharma, biotech, devices)
- Study start
- 9 Feb 2023 (actual)
- Primary completion
- 11 Apr 2023 (actual)
- Study completion
- 11 Apr 2023 (actual)
- First posted
- 15 Feb 2023 (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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| symptomatic | – | Diagnostic Test: LumiraDx SARS-CoV-2 Ag Ultra, Diagnostic Test: LumiraDx SARS-CoV-2 & Flu A/BSelf-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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
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 Ag UltraThe 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. | Diagnostic test | symptomatic |
| LumiraDx SARS-CoV-2 & Flu A/BThe 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. | Diagnostic test | symptomatic |
Primary outcome
Performance evaluation of the LumiraDx SARS-CoV-2 Ag Ultra by health care professionals
Time frame: 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
Time frame: 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.
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 12 Jun 2026.
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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.
Brian DuChateau, PhD study director
LumiraDx
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SARS-CoV-2 and Influenza A, run by LumiraDx UK Limited at 10 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 3 inclusion and 5 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 12 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 10 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 of the LumiraDx SARS-CoV-2 Ag Ultra by health care professionals (time frame: 6 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 12 Jun 2026; AzTrials last refreshed its copy on 7 Nov 2026.