Covid19CAPTURE-2NCT04597047
Research & Evaluation of LumiraDx SARS-CoV-2 (COVID-19) Point of Care Ab Test
An observational study of Covid19, run by LumiraDx UK Limited at 4 sites in United States.
Trial summary
Evaluation of the agreement between fingerstick samples, venous blood, serum and plasma samples when using the LumiraDx SARS-CoV-2 Ab Test against the reference method, using standard qualitative comparison techniques. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Capillary Collection & Testing and Venous Draw & Testing
- How many people
- 42 participants
- Where
- 4 sitesUnited States
- Study dates
- 9 Jul 2020to 3 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 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The subject must have a documented SARS-CoV-2 PCR test in the past 7-30 days. (subjects must be 14+ days post symptom onset at the time of recruitment).
Who may be able to join
- Male and female subjects aged ≥ 2 years.
- The subject must have a documented SARS-CoV-2 PCR test in the past 7-30 days. (subjects must be 14+ days post symptom onset at the time of recruitment).
- Written informed consent must be obtained prior to study enrollment.
- A subject who is 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 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
- Skin lesions or conditions that would preclude a fingerstick and or a venous blood draw.
- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Physicians Quality Care of Jackson
Jackson, Tennessee, 38305
Centura Health Physician Group, Northglenn Office
Northglenn, Colorado, 80234
Eclipse Clinical Research
Tucson, Arizona, 85745
Professional Research Network of Kansas
Wichita, Kansas, 67203
About this study
Official title: A Multicenter Covid-19 Study Conducted to Evaluate the Agreement Between Fingerstick Whole Blood, Venous Whole Blood, Plasma & Serum as Determined on the LumiraDx POC SARS-CoV-2 Ab Test & to Evaluate the Ease of Use at Point of Care Sites
Evaluation of the agreement between fingerstick samples, venous blood, serum and plasma samples when using the LumiraDx SARS-CoV-2 Ab Test against the reference method, using standard qualitative comparison techniques.
Read the detailed description
This is a prospective, multi-centre study. One (1) Reference Lab and approximately six (6) Healthcare or Research Facilities within geographic areas experiencing current Covid-19 outbreaks in the U.S. will participate in the study. Study sites may be Point of Care (POC) locations, such as physician office laboratories, urgent care and outpatient clinics, or dedicated research sites.
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 undergo two (2) fingerstick lancing's and 1 (one) venous blood draw. A total of eleven (11) tests (LumiraDx SARS-CoV-2 Ab and haematocrit) will then be performed using these samples. Specimens will be obtained from each subject enrolled using standard collection methods.
All operators at a site level performing the LumiraDx SARS-CoV-2 Ab POC Test in this study will be required to complete training detailing the running of the LumiraDx Test/Instrument. This will be completed as part of a familiarization period and all operators will be required to show proficiency in using the system for QC, fingerstick, whole blood, plasma and serum testing prior to testing subjects. This will be captured on relevant training forms as part of the site initiation visit. In addition, the operator's satisfaction and ease of use of the LumiraDx SARS-CoV-2 Ab Test will be evaluated by completing an Intended Use Operator Questionnaire.
The LumiraDx SARS-CoV-2 Ab POC Testing will be performed at the site on the same day as the date of collection. Samples will be shipped to a central laboratory for reference testing. Testing in the reference laboratory will be performed by trained laboratory personnel.
Approximately 200 subjects will be enrolled in this study. Approximately thirty (30) SARS-CoV-2 positive, and thirty (30) samples negative for SARS-CoV-2 will be enrolled at each site.
- Conditions
- Covid19
- Being tested
- Capillary Collection & Testing, Venous Draw & Testing
- Keywords
- POC, SARS-CoV-2, Antibody
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capillary Collection & TestingDiagnostic test
Two (2) fingersticks will be performed on each subject and capillary blood tested in the LumiraDx SARS-CoV-2 Ab test
Venous Draw & TestingDiagnostic test
One (1) Venous Draw (to include one (1) 6.0 mL EDTA tube and one (1) 3.5 mL serum separator tube) will be collected from each subject. Blood will be tested in the LumiraDx SARS-CoV-2 Ab test
| Study group | Role | What they receive |
|---|---|---|
| All Patients: | Capillary and Venous Blood Collections Receives: Diagnostic Test: Capillary Collection & Testing; Diagnostic Test: Venous Draw & Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance Evaluation
Evaluation of the agreement between fingerstick samples and venous blood samples on the device; and venous blood, serum and plasma samples on the device versus reference method, using standard qualitative comparison techniques.
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 posted22 Oct 2020
- Study start9 Jul 2020
- Primary completion3 Sep 2020
- Study completion3 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- LumiraDx UK Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vicki Kalen, Principal investigator, Eclipse Clinical ResearchWilliam Simon, Principal investigator, Professional Research Network of KansasMatthew Morgan, Principal investigator, Centura Health Physician GroupMelanie Hoppers, Principal investigator, Physicians Quality Care of Jackson
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04597047
- Sponsor's protocol ID
- S-CLIN-PROT-0031
- Acronym
- CAPTURE-2
- Status last verified
- Jun 2026
- First submitted
- 19 Oct 2020
- 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 Agreement Between Fingerstick Whole Blood, Venous Whole Blood, Plasma & Serum as Determined on the LumiraDx POC SARS-CoV-2 Ab Test & to Evaluate the Ease of Use at Point of Care Sites
- ClinicalTrials.gov ID
- NCT04597047
- Acronym / sponsor ID
- CAPTURE-2 / S-CLIN-PROT-0031
- Conditions
- Covid19
- Keywords
- POC, SARS-CoV-2, Antibody
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- LumiraDx UK LimitedIndustry (pharma, biotech, devices)
- Study start
- 9 Jul 2020 (actual)
- Primary completion
- 3 Sep 2020 (actual)
- Study completion
- 3 Sep 2020 (actual)
- First posted
- 22 Oct 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.
Evaluation of the agreement between fingerstick samples, venous blood, serum and plasma samples when using the LumiraDx SARS-CoV-2 Ab Test against the reference method, using standard qualitative comparison techniques.
Detailed description
This is a prospective, multi-centre study. One (1) Reference Lab and approximately six (6) Healthcare or Research Facilities within geographic areas experiencing current Covid-19 outbreaks in the U.S. will participate in the study. Study sites may be Point of Care (POC) locations, such as physician office laboratories, urgent care and outpatient clinics, or dedicated research sites.
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 undergo two (2) fingerstick lancing's and 1 (one) venous blood draw. A total of eleven (11) tests (LumiraDx SARS-CoV-2 Ab and haematocrit) will then be performed using these samples. Specimens will be obtained from each subject enrolled using standard collection methods.
All operators at a site level performing the LumiraDx SARS-CoV-2 Ab POC Test in this study will be required to complete training detailing the running of the LumiraDx Test/Instrument. This will be completed as part of a familiarization period and all operators will be required to show proficiency in using the system for QC, fingerstick, whole blood, plasma and serum testing prior to testing subjects. This will be captured on relevant training forms as part of the site initiation visit. In addition, the operator's satisfaction and ease of use of the LumiraDx SARS-CoV-2 Ab Test will be evaluated by completing an Intended Use Operator Questionnaire.
The LumiraDx SARS-CoV-2 Ab POC Testing will be performed at the site on the same day as the date of collection. Samples will be shipped to a central laboratory for reference testing. Testing in the reference laboratory will be performed by trained laboratory personnel.
Approximately 200 subjects will be enrolled in this study. Approximately thirty (30) SARS-CoV-2 positive, and thirty (30) samples negative for SARS-CoV-2 will be enrolled at each site.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Patients: | – | Diagnostic Test: Capillary Collection & Testing, Diagnostic Test: Venous Draw & TestingCapillary and Venous Blood Collections |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The subject must have a documented SARS-CoV-2 PCR test in the past 7-30 days. (subjects must be 14+ days post symptom onset at the time of recruitment).
Key inclusion criteria (5 listed)
- Male and female subjects aged ≥ 2 years.
- The subject must have a documented SARS-CoV-2 PCR test in the past 7-30 days. (subjects must be 14+ days post symptom onset at the time of recruitment).
- Written informed consent must be obtained prior to study enrollment.
Key exclusion criteria (3 listed)
- Skin lesions or conditions that would preclude a fingerstick and or a venous blood draw.
- 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.
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 |
|---|---|---|
| Capillary Collection & TestingTwo (2) fingersticks will be performed on each subject and capillary blood tested in the LumiraDx SARS-CoV-2 Ab test | Diagnostic test | All Patients: |
| Venous Draw & TestingOne (1) Venous Draw (to include one (1) 6.0 mL EDTA tube and one (1) 3.5 mL serum separator tube) will be collected from each subject. Blood will be tested in the LumiraDx SARS-CoV-2 Ab test | Diagnostic test | All Patients: |
Primary outcome
Performance Evaluation
Time frame: 4 months
Evaluation of the agreement between fingerstick samples and venous blood samples on the device; and venous blood, serum and plasma samples on the device versus reference method, using standard qualitative comparison techniques.
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.
Vicki Kalen principal investigator
Eclipse Clinical Research
William Simon principal investigator
Professional Research Network of Kansas
Matthew Morgan principal investigator
Centura Health Physician Group
4 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 4 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 5 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 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 4 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.