Covid19ASPIRENCT04557046
Performance Evaluation of LumiraDx COVID-19 (SARS-CoV-2) Ag Test
An observational study of Covid19, run by LumiraDx UK Limited at 7 sites in United States.
Trial summary
Performance of the LumiraDx SARS-CoV-2 Ag assay will be assessed by comparison to a reference method. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Covid19
- What is being tested?
- Nasal Swab, Nasopharyngeal swab and Throat swab
- How many people
- 1,134 participants
- Where
- 7 sitesUnited States
- Study dates
- 26 Jun 2020to 24 Sep 2020
- 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: Approximately six (6) geographically diverse POC (Point of Care) locations (e.g. physician office laboratories, urgent cares, emergency departments, outpatient clinics including drive through testing sites or research centers) in the U.S. will participate in the study. Males and females of any age may be enrolled, and should be represented in proportions representative of the population.
Who may be able to join
- 1. The subject may be of any age and either sex.
- 2. 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. The onset of these symptoms will be recorded.
- or The subject must have a documented SARS-CoV-2 PCR test in the past 48 hours.
- 3. Written informed consent must be obtained prior to study enrollment.
- A subject who is eighteen (18) years or older 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 eighteen (18) must give written informed consent and agree to comply with study procedures. Active written assent should be obtained from children of appropriate intellectual age (as defined by the IRB).
Who cannot join
- 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. The subject has previously participated in this research study
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Children's Pediatric Associates of Altamonte Springs
Altamonte Springs, Florida, 32701
Good Samaritan Minute Clinic, Georgia Tech
Atlanta, Georgia, 30318
Physicians Quality Care of Jackson
Jackson, Tennessee, 38305
Chappel Group
Kissimmee, Florida, 34744
Gvozden Pediatrics
Millersville, Maryland, 21108
Village Health Partners
Plano, Texas, 75024
Ardmore Family Practice
Winston-Salem, North Carolina, 27103
About this study
Official title: A Multicenter COVID-19 Study Conducted to Evaluate the Performance of the LumiraDx SARS-CoV-2 Ag Test at Point of Care Testing Sites
Performance of the LumiraDx SARS-CoV-2 Ag assay will be assessed by comparison to a reference method.
Read the detailed description
The study is a prospective, multi-center study. One (1) reference laboratory and approximately six (6) geographically diverse POC (Point of Care) locations (e.g. physician office laboratories, urgent cares, emergency departments, outpatient clinics, drive through testing sites or research centers) in the U.S. will participate in the study. Testing in the reference laboratory will be performed by trained laboratory personnel. Testing at the POC sites will be performed by non-laboratory health professionals who are representative of typical intended use operators (e.g. nurses, physician assistants, medical assistants, etc.). Each site will have a minimum of one (1) untrained intended use operator who will perform testing under this protocol.
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.
Subjects will have nasopharyngeal or nasal or throat swabs collected. Capillary blood may be collected alongside nasal swabs. Saliva samples may also be collected. Specimens will be obtained from each subject enrolled using standard collection methods.
The LumiraDx SARS-CoV-2 Ag Test will be performed at POC sites by intended use operators (e.g. nurses, physician assistants, medical assistants, etc.). Each site will have a minimum of one (1) untrained intended use operator who will perform testing under this protocol.
The LumiraDx SARS-CoV-2 Ag Test will be performed at the site on the same day as the date of collection using one swab for each subject enrolled. A central laboratory will perform reference testing.
Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) will be estimated for the LumiraDx SARS-CoV-2 Ag Test results as compared with the reference Test.
A minimum of thirty (30) positive SARS-CoV-2 are required, but it is likely because of the prevalence of SARS-CoV-2 in the population, that a greater number of negatives will be obtained during the prospective collection of positive samples; therefore, approximately four-hundred (400) subjects will be enrolled. A minimum of thirty (30) negative samples are required.
- Conditions
- Covid19
- Being tested
- Nasal Swab, Nasopharyngeal swab, Throat swab, Fingerstick, Saliva specimen
- Keywords
- POC, SARS-CoV-2, Antigen
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal SwabDiagnostic test
Collection of one more nasal swabs
Nasopharyngeal swabDiagnostic test
Collection of one more nasopharyngeal swabs
Throat swabDiagnostic test
Collection of one more throat swabs
FingerstickDiagnostic test
Collection of capillary blood from one or more fingersticks
Saliva specimenDiagnostic test
Collection of free drool
| Study group | Role | What they receive |
|---|---|---|
| Group A: Sample Collection | Nasal Swab and Saliva Sample Collection Receives: Diagnostic Test: Nasal Swab; Diagnostic Test: Saliva specimen | |
| Group B: Sample Collection | Nasal swab, Capillary Blood (from fingerstick) and Saliva Collection Receives: Diagnostic Test: Nasal Swab; Diagnostic Test: Fingerstick; Diagnostic Test: Saliva specimen | |
| Group C: Sample Collection | Nasal Swab, Throat Swab and Saliva Sample Collection Receives: Diagnostic Test: Nasal Swab; Diagnostic Test: Throat swab; Diagnostic Test: Saliva specimen | |
| Group D: Sample Collection | Nasopharyngeal Swab and Saliva Sample Collection Receives: Diagnostic Test: Nasopharyngeal swab; Diagnostic Test: Saliva specimen | |
| Group E: Sample Collection | Nasal swab Receives: Diagnostic Test: Nasal Swab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance Evaluation
Evaluation of performance of the device versus a reference method using standard qualitative comparison techniques (Percent Agreement)
Measured: On day of the medical encounter (1 day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2020
- Study start26 Jun 2020
- Primary completion24 Sep 2020
- Study completion24 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies 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
- 1,134 participants (actual)
Sponsor and investigators
- Lead sponsor
- LumiraDx UK Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christopher Chappel, Principal investigator, Chappel GroupRobert Rosen, Principal investigator, Ardmore Family PracticeAndre Gvozden, Principal investigator, Gvozden PediatricsMadhavi Ampajwala, Principal investigator, Village Health PartnersEdward Zissman, Principal investigator, Pediatric Associates of Altamonte SpringsMelanie Hoppers, Principal investigator, Physicians Quality Care of JacksonKimberley Henderson, Principal investigator, Good Samaritan Minute Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04557046
- Sponsor's protocol ID
- S-CLIN-PROT-00032
- Acronym
- ASPIRE
- Status last verified
- Jun 2026
- First submitted
- 17 Sep 2020
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Ellis JE, Guest P, Lawson V, Loecherbach J, Lindner N, McCulloch A. Performance Evaluation of the Microfluidic Antigen LumiraDx SARS-CoV-2 and Flu A/B Test in Diagnosing COVID-19 and Influenza in Patients with Respiratory Symptoms. Infect Dis Ther. 2022 Dec;11(6):2099-2109. doi: 10.1007/s40121-022-00696-8. Epub 2022 Sep 24.
PubMed 36152227Drain PK, Ampajwala M, Chappel C, Gvozden AB, Hoppers M, Wang M, Rosen R, Young S, Zissman E, Montano M. A Rapid, High-Sensitivity SARS-CoV-2 Nucleocapsid Immunoassay to Aid Diagnosis of Acute COVID-19 at the Point of Care: A Clinical Performance Study. Infect Dis Ther. 2021 Jun;10(2):753-761. doi: 10.1007/s40121-021-00413-x. Epub 2021 Feb 24.
PubMed 33629225
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 Multicenter COVID-19 Study Conducted to Evaluate the Performance of the LumiraDx SARS-CoV-2 Ag Test at Point of Care Testing Sites
- ClinicalTrials.gov ID
- NCT04557046
- Acronym / sponsor ID
- ASPIRE / S-CLIN-PROT-00032
- Conditions
- Covid19
- Keywords
- POC, SARS-CoV-2, Antigen
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,134 participants (actual)
- Lead sponsor
- LumiraDx UK LimitedIndustry (pharma, biotech, devices)
- Study start
- 26 Jun 2020 (actual)
- Primary completion
- 24 Sep 2020 (actual)
- Study completion
- 24 Sep 2020 (actual)
- First posted
- 21 Sep 2020 (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.
Performance of the LumiraDx SARS-CoV-2 Ag assay will be assessed by comparison to a reference method.
Detailed description
The study is a prospective, multi-center study. One (1) reference laboratory and approximately six (6) geographically diverse POC (Point of Care) locations (e.g. physician office laboratories, urgent cares, emergency departments, outpatient clinics, drive through testing sites or research centers) in the U.S. will participate in the study. Testing in the reference laboratory will be performed by trained laboratory personnel. Testing at the POC sites will be performed by non-laboratory health professionals who are representative of typical intended use operators (e.g. nurses, physician assistants, medical assistants, etc.). Each site will have a minimum of one (1) untrained intended use operator who will perform testing under this protocol.
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.
Subjects will have nasopharyngeal or nasal or throat swabs collected. Capillary blood may be collected alongside nasal swabs. Saliva samples may also be collected. Specimens will be obtained from each subject enrolled using standard collection methods.
The LumiraDx SARS-CoV-2 Ag Test will be performed at POC sites by intended use operators (e.g. nurses, physician assistants, medical assistants, etc.). Each site will have a minimum of one (1) untrained intended use operator who will perform testing under this protocol.
The LumiraDx SARS-CoV-2 Ag Test will be performed at the site on the same day as the date of collection using one swab for each subject enrolled. A central laboratory will perform reference testing.
Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) will be estimated for the LumiraDx SARS-CoV-2 Ag Test results as compared with the reference Test.
A minimum of thirty (30) positive SARS-CoV-2 are required, but it is likely because of the prevalence of SARS-CoV-2 in the population, that a greater number of negatives will be obtained during the prospective collection of positive samples; therefore, approximately four-hundred (400) subjects will be enrolled. A minimum of thirty (30) negative samples are required.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group A: Sample Collection | – | Diagnostic Test: Nasal Swab, Diagnostic Test: Saliva specimenNasal Swab and Saliva Sample Collection |
| Group B: Sample Collection | – | Diagnostic Test: Nasal Swab, Diagnostic Test: Fingerstick, Diagnostic Test: Saliva specimenNasal swab, Capillary Blood (from fingerstick) and Saliva Collection |
| Group C: Sample Collection | – | Diagnostic Test: Nasal Swab, Diagnostic Test: Throat swab, Diagnostic Test: Saliva specimenNasal Swab, Throat Swab and Saliva Sample Collection |
| Group D: Sample Collection | – | Diagnostic Test: Nasopharyngeal swab, Diagnostic Test: Saliva specimenNasopharyngeal Swab and Saliva Sample Collection |
| Group E: Sample Collection | – | Diagnostic Test: Nasal SwabNasal swab |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Approximately six (6) geographically diverse POC (Point of Care) locations (e.g. physician office laboratories, urgent cares, emergency departments, outpatient clinics including drive through testing sites or research centers) in the U.S. will participate in the study. Males and females of any age may be enrolled, and should be represented in proportions representative of the population.
Key inclusion criteria (6 listed)
- 1. The subject may be of any age and either sex.
- 2. 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. The onset of these symptoms will be recorded.
- or The subject must have a documented SARS-CoV-2 PCR test in the past 48 hours.
- 3. Written informed consent must be obtained prior to study enrollment.
Key exclusion criteria (3 listed)
- 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. The subject has previously participated in this research 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 |
|---|---|---|
| Nasal SwabCollection of one more nasal swabs | Diagnostic test | Group A: Sample Collection, Group B: Sample Collection, Group C: Sample Collection, Group E: Sample Collection |
| Nasopharyngeal swabCollection of one more nasopharyngeal swabs | Diagnostic test | Group D: Sample Collection |
| Throat swabCollection of one more throat swabs | Diagnostic test | Group C: Sample Collection |
| FingerstickCollection of capillary blood from one or more fingersticks | Diagnostic test | Group B: Sample Collection |
| Saliva specimenCollection of free drool | Diagnostic test | Group A: Sample Collection, Group B: Sample Collection, Group C: Sample Collection, Group D: Sample Collection |
Primary outcome
Performance Evaluation
Time frame: On day of the medical encounter (1 day)
Evaluation of performance of the device versus a reference method using standard qualitative comparison techniques (Percent 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.
- Derived from this study: PubMed 36152227Ellis JE, Guest P, Lawson V, Loecherbach J, Lindner N, McCulloch A. Performance Evaluation of the Microfluidic Antigen LumiraDx SARS-CoV-2 and Flu A/B Test in Diagnosing COVID-19 and Influenza in Patients with Respiratory Symptoms. Infect Dis Ther. 2022 Dec;11(6):2099-2109. doi: 10.1007/s40121-022-00696-8. Epub 2022 Sep 24.
- Derived from this study: PubMed 33629225Drain PK, Ampajwala M, Chappel C, Gvozden AB, Hoppers M, Wang M, Rosen R, Young S, Zissman E, Montano M. A Rapid, High-Sensitivity SARS-CoV-2 Nucleocapsid Immunoassay to Aid Diagnosis of Acute COVID-19 at the Point of Care: A Clinical Performance Study. Infect Dis Ther. 2021 Jun;10(2):753-761. doi: 10.1007/s40121-021-00413-x. Epub 2021 Feb 24.
- 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.
Christopher Chappel principal investigator
Chappel Group
Robert Rosen principal investigator
Ardmore Family Practice
Andre Gvozden principal investigator
Gvozden Pediatrics
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by LumiraDx UK Limited at 7 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 6 inclusion and 3 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 7 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 (time frame: On day of the medical encounter (1 day)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04557046, which also lists 2 linked publications.
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.