COVID-19ASPIRE-2NCT05506618
Performance Evaluation of LumiraDx COVID-19 (SARS-CoV-2) Ag ULTRA Test
An observational study of COVID-19, run by LumiraDx UK Limited at 6 sites in United States.
Trial summary
Performance of the LumiraDx SARS-CoV-2 Ag ULTRA assay will be assessed by comparison to a reference method Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- Nasal Swab and Nasopharyngeal swab
- How many people
- 758 participants
- Where
- 6 sitesUnited States
- Study dates
- 30 Jun 2022to 4 Oct 2022
- 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: Symptomatic patients presented to the participating healthcare facilities, urgent care centers, or research sites
Who may be able to join
- Subject may be of any age or gender.
- 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 within the last twelve (12) days.
- or The subject is asymptomatic and is neither currently exhibiting signs or symptoms of SARS-CoV-2 nor has experienced signs or symptoms within the past fourteen (14) days, and has not knowingly been exposed to someone with a positive test result within the last fourteen (14) 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 like illness symptoms, which may include but is not limited to Remdesivir or convalescent plasma therapy for SARS-CoV-2.
- The subject has previously participated in this research study.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Cahaba Research, Inc.
Birmingham, Alabama, 35242
Cyn3rgy Research
Gresham, Oregon, 97030
Advanced Investigative Medicine
Hawthorne, California, 90250
Zion Urgent Care
Katy, Texas, 77494
The Machuca Foundation, Inc.
Las Vegas, Nevada, 89104
Healthy Life Research, Inc.
Miami, Florida, 33175
About this study
Official title: A Multicenter COVID-19 Study Conducted to Evaluate the Performance of the LumiraDx SARS-CoV-2 Ag ULTRA Test at Point of Care Testing Sites
Performance of the LumiraDx SARS-CoV-2 Ag ULTRA 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. Specimens will be obtained from each subject enrolled using standard collection methods.
The LumiraDx SARS-CoV-2 Ag ULTRA 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 ULTRA 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 ULTRA 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
- COVID-19
- Being tested
- Nasal Swab, Nasopharyngeal swab
- 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
| Study group | Role | What they receive |
|---|---|---|
| Group A: Sample Collection | 2x Nasopharyngeal Swab Sample Collection Receives: Diagnostic Test: Nasopharyngeal swab | |
| Group B: Sample Collection | 1x Nasopharyngeal Swab and 2x Nasal Swab Sample Collection Receives: Diagnostic Test: Nasal Swab; Diagnostic Test: Nasopharyngeal 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: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2022
- Study start30 Jun 2022
- Primary completion4 Oct 2022
- Study completion4 Oct 2022
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
- 758 participants (actual)
Sponsor and investigators
- Lead sponsor
- LumiraDx UK Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christine Girgis, MD, Principal investigator, Advanced Investigative MedicineMichael Vaughn, MD, Principal investigator, Cahaba Research, Inc.Frank Calcagno, MD, Principal investigator, Cyn3rgy ResearchHilda Brito, MD, Principal investigator, Healthy Life Research, Inc.Rogelio Machuca, MD, Principal investigator, The Machuca Foundation, Inc.Tewodros Teketel, MD, Principal investigator, Zion Urgent Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05506618
- Sponsor's protocol ID
- S-CLIN-PROT-00053
- Acronym
- ASPIRE-2
- Status last verified
- Jun 2026
- First submitted
- 17 Aug 2022
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- 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 COVID-19 Study Conducted to Evaluate the Performance of the LumiraDx SARS-CoV-2 Ag ULTRA Test at Point of Care Testing Sites
- ClinicalTrials.gov ID
- NCT05506618
- Acronym / sponsor ID
- ASPIRE-2 / S-CLIN-PROT-00053
- Conditions
- COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 758 participants (actual)
- Lead sponsor
- LumiraDx UK LimitedIndustry (pharma, biotech, devices)
- Study start
- 30 Jun 2022 (actual)
- Primary completion
- 4 Oct 2022 (actual)
- Study completion
- 4 Oct 2022 (actual)
- First posted
- 18 Aug 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.
Performance of the LumiraDx SARS-CoV-2 Ag ULTRA 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. Specimens will be obtained from each subject enrolled using standard collection methods.
The LumiraDx SARS-CoV-2 Ag ULTRA 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 ULTRA 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 ULTRA 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
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Sample Collection | – | Diagnostic Test: Nasopharyngeal swab2x Nasopharyngeal Swab Sample Collection |
| Group B: Sample Collection | – | Diagnostic Test: Nasal Swab, Diagnostic Test: Nasopharyngeal swab1x Nasopharyngeal Swab and 2x Nasal Swab Sample Collection |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Symptomatic patients presented to the participating healthcare facilities, urgent care centers, or research sites
Key inclusion criteria (4 listed)
- Subject may be of any age or gender.
- 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 within the last twelve (12) days.
- or The subject is asymptomatic and is neither currently exhibiting signs or symptoms of SARS-CoV-2 nor has experienced signs or symptoms within the past fourteen (14) days, and has not knowingly been exposed to someone with a positive test result within the last fourteen (14) days
- Participant (or parent/legal guardian) capable and willing to give informed consent/assent.
Key exclusion criteria (4 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 like illness symptoms, which may include but is not limited to Remdesivir or convalescent plasma therapy for SARS-CoV-2.
- 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 B: Sample Collection |
| Nasopharyngeal swabCollection of one more nasopharyngeal swabs | Diagnostic test | Group A: Sample Collection, Group B: Sample Collection |
Primary outcome
Performance Evaluation
Time frame: 4 months
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 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.
Christine Girgis, MD principal investigator
Advanced Investigative Medicine
Michael Vaughn, MD principal investigator
Cahaba Research, Inc.
Frank Calcagno, MD principal investigator
Cyn3rgy Research
6 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, run by LumiraDx UK Limited at 6 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 4 inclusion and 4 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 6 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: 4 months). 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.