SARS-CoV-2ITAP1489NCT05787444
Clinical Validation of the LumiraDx SARS-CoV-2 & Flu A/B Combo Test
An observational study of SARS-CoV-2 and Influenza A, run by LumiraDx UK Limited at 1 site in United States.
Trial summary
This is a prospective multicenter study conducted to evaluate the performance of the LumiraDx SARS-CoV-2 \& Flu A/B tests at point of care sites. Subjects presenting with symptoms suggestive of coronavirus disease 2019 (COVID-19) and Influenza at the time of the study visit will be enrolled and asked to donate swab… Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- SARS-CoV-2, Influenza A, Influenza B
- What is being tested?
- LumiraDx SARS-CoV-2 & Flu A/B
- How many people
- 1,081 participants
- Where
- 1 siteUnited States
- Study dates
- 4 May 2023to 2 Apr 2024
- 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 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The entire population that met the eligibility criteria. Symptomatic subjects who are currently exhibiting two or more symptoms associated with COVID-19 or influenza and present within 6 days of symptom onset. Subject must still be exhibiting symptoms on the day of sample collection.
Who may be able to join
- Written informed consent obtained prior to study enrollment.
- Male or female aged 2 years of age or older
- Subject is currently exhibiting two or more symptoms associated with COVID-19 or influenza (such as, but not limited to, fever, chills, cough, shortness of breath or difficulty breathing, fatigue, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting or diarrhea) and must present within 6 days of symptom onset. Subject must still be exhibiting symptoms on the day of sample collection.
Who cannot join
- Subject does not understand or is not able and willing to sign the study informed consent or be verbally assented.
- Subject has had the seasonal influenza and/or the SARS-CoV-2 vaccine within the past 5 days.
- Subject is not able to tolerate sample collection.
- Subject is currently undergoing antiviral treatment such as baloxavir marboxil (trade name Xofluza®), oseltamivir (Tamiflu®), zanamivir (Relenza®), and peramivir (Rapivab®).
- Subjects undergoing treatment currently and/or within the past thirty (30) days with prescription medication to treat novel Coronavirus SARS-CoV-2 infection, which may include but is not limited to Remdesivir (Veklury), Paxlovid, molnupiravir or receiving convalescent plasma therapy for SARS-CoV-2.
- Subjects who have taken Evusheld (tixagevimab/cilgavimab) within the last 90 days.
- Subjects who have had a nasal wash or aspirate as part of their standard of care treatment on day of study visit prior to study sample collection.
- Subjects who have had recent craniofacial injury or surgery, including to correct deviation of the nasal septum, within the previous six (6) months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Validation of the LumiraDx SARS-CoV-2 & Flu A/B Test in Anterior Nares Nasal Samples For Point-of-Care (POC) Use
This is a prospective multicenter study conducted to evaluate the performance of the LumiraDx SARS-CoV-2 \& Flu A/B tests at point of care sites. Subjects presenting with symptoms suggestive of coronavirus disease 2019 (COVID-19) and Influenza at the time of the study visit will be enrolled and asked to donate swab sample(s) for testing on the device under evaluation.
Read the detailed description
This will be a prospective study at point of care sites in the United States for the clinical validation of the LumiraDx SARS-CoV-2 \& Flu A/B test for the differential detection of the SARS-CoV-2, and influenza A \& B using anterior nasal samples. Up to 1,500 or more symptomatic subjects who are currently experiencing symptoms associated with COVID-19 and Influenza A \& B may be enrolled.
The samples are obtained from each subject using standard collection methods and are processed and tested by untrained operators without laboratory training and with no prior experience using the candidate test.
The primary objective of this study is to evaluate the performance (positive percent agreement, negative percent agreement and 95% confidence intervals for upper and lower bounds) of the LumiraDx SARS-CoV-2 \& Flu A/B test for the qualitative and differential detection of SARS-CoV-2, Influenza A \& B virus antigen using anterior nares samples collected by a healthcare professional, compared to a 510(k) cleared or Emergency Use Authorized (EUA) high-sensitivity reverse transcription-polymerase chain reaction (RT-PCR) test for COVID-19 and a 510(k) cleared Influenza A/B test.
The secondary objective is to assess the usability and user accuracy/performance around limit of detection (LoD) of the investigational test using a questionnaire and accuracy study.
- Conditions
- SARS-CoV-2, Influenza A, Influenza B, Asymptomatic COVID-19
- Being tested
- LumiraDx SARS-CoV-2 & Flu A/B
- Keywords
- LumiraDx Diagnostic tests, Multiplex SARS-CoV-2, Influenza A, Influenza B, Asymptomatic, COVID-19 Infections, Coronavirus Lung disease
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/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 and differential detection of nucleocapsid viral antigens from SARS-CoV-2, influenza A, and influenza B in an anterior nares sample (from both nostrils) collected by a healthcare professional for individuals aged 2 years and older. The test is authorized for individuals with symptoms of COVID-19, influenza A and B within the first 6 days of symptom onset.
| Study group | Role | What they receive |
|---|---|---|
| symptomatic | Subject is currently exhibiting two or more symptoms associated with COVID-19 or influenza (such as, but not limited to, fever, chills, cough, shortness of breath or difficulty breathing, fatigue, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting or diarrhea) and must present within 6 days of symptom onset. Subject must still be exhibiting symptoms on the day of sample collection. Receives: 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 & Flu A/B in point of care settings
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 negative and positive percent agreement (NPA, PPA) of the LumiraDx test results versus an FDA-approved method where a result of 100% NPA or PPA would equate to complete agreement with the reference method and 0% would equate to no agreement.
Measured: 6 months
Secondary outcomes (1)
Validation of the LumiraDx SARS-CoV-2 & Flu A/B for use by intended users
Each site will conduct testing with contrived samples prepared by the Sponsor in a User Accuracy study. Additionally, each operator will complete a usability questionnaire evaluating various features of the investigational test and instructions. Users will use the Likert scale (strongly agree - strongly disagree) to rate their responses. Results will be collated and assessed.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2023
- Study start4 May 2023
- Primary completion2 Apr 2024
- Study completion2 Apr 2024
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
- 1,081 participants (actual)
Sponsor and investigators
- Lead sponsor
- LumiraDx UK Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Randall Quinn, MD, Principal investigator, Cullman Clinical Trials
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05787444
- Sponsor's protocol ID
- CS-1489-01
- Other IDs
- 13379
- Acronym
- ITAP1489
- Status last verified
- Jun 2026
- First submitted
- 16 Mar 2023
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Validation of the LumiraDx SARS-CoV-2 & Flu A/B Test in Anterior Nares Nasal Samples For Point-of-Care (POC) Use
- ClinicalTrials.gov ID
- NCT05787444
- Acronym / sponsor ID
- ITAP1489 / CS-1489-01
- Conditions
- SARS-CoV-2, Influenza A, Influenza B, Asymptomatic COVID-19
- Keywords
- LumiraDx Diagnostic tests, Multiplex SARS-CoV-2, Influenza A, Influenza B, Asymptomatic, COVID-19 Infections, Coronavirus Lung disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,081 participants (actual)
- Lead sponsor
- LumiraDx UK LimitedIndustry (pharma, biotech, devices)
- Study start
- 4 May 2023 (actual)
- Primary completion
- 2 Apr 2024 (actual)
- Study completion
- 2 Apr 2024 (actual)
- First posted
- 28 Mar 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 \& Flu A/B tests at point of care sites. Subjects presenting with symptoms suggestive of coronavirus disease 2019 (COVID-19) and Influenza at the time of the study visit will be enrolled and asked to donate swab sample(s) for testing on the device under evaluation.
Detailed description
This will be a prospective study at point of care sites in the United States for the clinical validation of the LumiraDx SARS-CoV-2 \& Flu A/B test for the differential detection of the SARS-CoV-2, and influenza A \& B using anterior nasal samples. Up to 1,500 or more symptomatic subjects who are currently experiencing symptoms associated with COVID-19 and Influenza A \& B may be enrolled.
The samples are obtained from each subject using standard collection methods and are processed and tested by untrained operators without laboratory training and with no prior experience using the candidate test.
The primary objective of this study is to evaluate the performance (positive percent agreement, negative percent agreement and 95% confidence intervals for upper and lower bounds) of the LumiraDx SARS-CoV-2 \& Flu A/B test for the qualitative and differential detection of SARS-CoV-2, Influenza A \& B virus antigen using anterior nares samples collected by a healthcare professional, compared to a 510(k) cleared or Emergency Use Authorized (EUA) high-sensitivity reverse transcription-polymerase chain reaction (RT-PCR) test for COVID-19 and a 510(k) cleared Influenza A/B test.
The secondary objective is to assess the usability and user accuracy/performance around limit of detection (LoD) of the investigational test using a questionnaire and accuracy study.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| symptomatic | – | Diagnostic Test: LumiraDx SARS-CoV-2 & Flu A/BSubject is currently exhibiting two or more symptoms associated with COVID-19 or influenza (such as, but not limited to, fever, chills, cough, shortness of breath or difficulty breathing, fatigue, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting or diarrhea) and must present within 6 days of symptom onset. Subject must still be exhibiting symptoms on the day of sample collection. |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The entire population that met the eligibility criteria. Symptomatic subjects who are currently exhibiting two or more symptoms associated with COVID-19 or influenza and present within 6 days of symptom onset. Subject must still be exhibiting symptoms on the day of sample collection.
Key inclusion criteria (3 listed)
- Written informed consent obtained prior to study enrollment.
- Male or female aged 2 years of age or older
- Subject is currently exhibiting two or more symptoms associated with COVID-19 or influenza (such as, but not limited to, fever, chills, cough, shortness of breath or difficulty breathing, fatigue, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting or diarrhea) and must present within 6 days of symptom onset. Subject must still be exhibiting symptoms on the day of sample collection.
Key exclusion criteria (8 listed)
- Subject does not understand or is not able and willing to sign the study informed consent or be verbally assented.
- Subject has had the seasonal influenza and/or the SARS-CoV-2 vaccine within the past 5 days.
- Subject is not able to tolerate sample collection.
- Subject is currently undergoing antiviral treatment such as baloxavir marboxil (trade name Xofluza®), oseltamivir (Tamiflu®), zanamivir (Relenza®), and peramivir (Rapivab®).
- Subjects undergoing treatment currently and/or within the past thirty (30) days with prescription medication to treat novel Coronavirus SARS-CoV-2 infection, which may include but is not limited to Remdesivir (Veklury), Paxlovid, molnupiravir or receiving convalescent plasma therapy for SARS-CoV-2.
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/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 and differential detection of nucleocapsid viral antigens from SARS-CoV-2, influenza A, and influenza B in an anterior nares sample (from both nostrils) collected by a healthcare professional for individuals aged 2 years and older. The test is authorized for individuals with symptoms of COVID-19, influenza A and B within the first 6 days of symptom onset. | Diagnostic test | symptomatic |
Primary outcome
Performance evaluation of the LumiraDx SARS-CoV-2 & Flu A/B in point of care settings
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 negative and positive percent agreement (NPA, PPA) of the LumiraDx test results versus an FDA-approved method where a result of 100% NPA or PPA would equate to complete agreement with the reference method and 0% would equate to no agreement.
1 secondary outcome
Validation of the LumiraDx SARS-CoV-2 & Flu A/B for use by intended users
Time frame: 2 months
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 11 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.
Randall Quinn, MD principal investigator
Cullman Clinical Trials
1 site 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 1 site 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 8 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 11 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 1 site 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 & Flu A/B in point of care settings (time frame: 6 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 11 Jun 2026.