Embolism and ThrombosisNOVEL-3NCT04375982
Evaluation of the LumiraDx Point of Care D-Dimer and CRP Tests
An observational study of Embolism and Thrombosis and Infection, run by LumiraDx UK Limited at 4 sites in United States.
Trial summary
A Multicenter Study Conducted to Evaluate the Agreement between Fingerstick Whole Blood, Venous Whole Blood and Plasma Determined on the LumiraDx Point of Care D-Dimer and Point of Care CRP Tests to Results on the Reference Analyzer Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Embolism and Thrombosis, Infection, Inflammation
- What is being tested?
- Venepuncture and Fingerstick
- How many people
- 111 participants
- Where
- 4 sitesUnited States
- Study dates
- 20 Apr 2020to 5 Apr 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects >18 years old presenting to primary care provider with a variety of conditions as described in Inclusion/Exclusion criteria.
Who may be able to join
- Subjects >18 years of age.
- Willing and able to provide written informed consent and comply with study procedures.
- Presenting to healthcare provider for any reason* *All presentations are suitable for recruitment; however, the following conditions are of particular interest: Venous thromboembolism symptoms (DVT and Pulmonary embolism), subjects seeking medical attention with symptoms of respiratory tract infection (upper or lower), Acute myocardial infarction / unstable angina, Anti-inflammatory medication (current), Any regular medication for a chronic condition (other than simple painkiller or inhaler), Atrial fibrillation, Diabetes mellitus (all types except 'pre-diabetes'), Heart failure, Hypertension (>150/90), Infection (significant current or within 3 months), Peripheral arterial disease, Surgery (within 6 weeks), Childbirth (within 8 weeks), Significant trauma, burns (within 4 weeks), Pregnancy (confirmed or suspected), Acute upper gastrointestinal haemorrhage other significant recent haemorrhage.
- D-dimer Exclusion Criteria:
- The subject is currently receiving or has received within the past thirty (30) days of the study visit an experimental biologic or drug including either treatment or therapy.
- Skin lesions or conditions that would preclude a fingerstick and or a venous blood draw.
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- End-stage renal failure on haemodialysis.
- Life expectancy documented as less than 30 days.
- Haemodynamically unstable (e.g. cardiogenic shock).
- Current anticoagulation therapy (Fragmin, LMWH) within the last 30 days.
- Patients taking anticoagulant therapy (DOACS, Warfarin, Heparins etc.) within the last 30 days.
- The subject has previously participated in this research study
- CRP Inclusion criteria:
- Subjects >18 years of age.
- Willing and able to provide written informed consent and comply with study procedures.
- Subjects seeking medical attention with symptoms of infection, tissue injury, inflammatory disorders or associated disease. This includes but not limited to: respiratory tract infection (upper or lower), rheumatoid arthritis, Lupus, burns, trauma, inflammatory bowel disease.
- CRP Exclusion Criteria:
- The subject is currently receiving or has received within the past thirty (30) days of the study visit an experimental biologic or drug including either treatment or therapy.
- Skin lesions or conditions that would preclude a fingerstick and or a venous blood draw.
- A subject with a critical illness, requiring critical intervention, or end of life or palliative care.
- Subjects suffering with Myeloma, Monoclonal Gammopathy or extreme Lipaemia.
- The subject has previously participated in this research study
Who cannot join
None listed.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Rancho Paseo Medical Group
Banning, California, 92220
Diagnostic Clinic of Longview
Longview, Texas, 75605
Centura Health Physician Group
Northglenn, Colorado, 80234
New Medical Healthcare
Wichita, Kansas, 67212
About this study
Official title: A Multicenter Study Conducted to Evaluate the Agreement Between Fingerstick Whole Blood, Venous Whole Blood and Plasma Determined on the LumiraDx Point of Care D-Dimer and Point of Care CRP Tests to Results on the Reference Analyzer
A Multicenter Study Conducted to Evaluate the Agreement between Fingerstick Whole Blood, Venous Whole Blood and Plasma Determined on the LumiraDx Point of Care D-Dimer and Point of Care CRP Tests to Results on the Reference Analyzer
Read the detailed description
The purpose of the study is to gather data to determine agreement between sample types, which together with performance evaluation data will be used to support CE marking under Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices 3, using ISO 13612:2002 - Performance Evaluation of In Vitro Diagnostic Medical Devices as the standard. The investigative devices are the LumiraDx Platform D Dimer Test and the LumiraDx Platform CRP Test. The LumiraDx Platform employs a portable diagnostic instrument used with single use D Dimer or CRP Assay Test Strips.
Agreement of the different sample types to the reference method will be demonstrated across a patient population representative of the indication for use of the products. Operators will be trained clinical site staff who are representative of the intended users of the product, i.e. health care professionals at the point of care such as nurses, technicians, doctors, etc. A panel of whole blood and plasma samples will be obtained from each patient in order to assess the accuracy of the investigative device across all sample types.
- Conditions
- Embolism and Thrombosis, Infection, Inflammation
- Being tested
- Venepuncture, Fingerstick
- Medical subject headings
- Embolism and Thrombosis, Infections, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VenepunctureDiagnostic test
Blood tube will be collected from standard venepuncture
FingerstickDiagnostic test
Capillary blood will be collected by fingerstick
| Study group | Role | What they receive |
|---|---|---|
| Blood collection / CRP Cohort | Venepuncture and fingerstick to obtain venous blood and capillary blood respectively Receives: Diagnostic Test: Venepuncture; Diagnostic Test: Fingerstick | |
| Blood collection / D Dimer Cohort | Venepuncture and fingerstick to obtain venous blood and capillary blood respectively Receives: Diagnostic Test: Venepuncture; Diagnostic Test: Fingerstick |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of sample matrix comparison
Verification that all sample types give an equivalent result when tested in the LumiraDx assays. Results generated from capillary blood and venous whole blood will be compared to those generated from plasma to ensure that all 3 sample types give equivalent values. Results will be compared by standard statisitical techniques which may include Regression analysis (e.g. Passing Bablok) or Bias analysis (e.g. Altman Bland)
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 posted6 May 2020
- Study start20 Apr 2020
- Primary completion5 Apr 2022
- Study completion5 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Embolism and ThrombosisStudies 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
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- LumiraDx UK Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Judith Kirstein, Principal investigator, Rancho Paseo Medical GroupMatthew Morgan, Principal investigator, Centura Health Physician GroupAnita Scribner, Principal investigator, Diagnostic Clinic of LongviewWilliam Simon, Principal investigator, New Medical Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04375982
- Sponsor's protocol ID
- S-CLIN-PROT-00027
- Acronym
- NOVEL-3
- Status last verified
- Jun 2026
- First submitted
- 30 Apr 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 Study Conducted to Evaluate the Agreement Between Fingerstick Whole Blood, Venous Whole Blood and Plasma Determined on the LumiraDx Point of Care D-Dimer and Point of Care CRP Tests to Results on the Reference Analyzer
- ClinicalTrials.gov ID
- NCT04375982
- Acronym / sponsor ID
- NOVEL-3 / S-CLIN-PROT-00027
- Conditions
- Embolism and Thrombosis, Infection, Inflammation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- LumiraDx UK LimitedIndustry (pharma, biotech, devices)
- Study start
- 20 Apr 2020 (actual)
- Primary completion
- 5 Apr 2022 (actual)
- Study completion
- 5 Apr 2022 (actual)
- First posted
- 6 May 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.
A Multicenter Study Conducted to Evaluate the Agreement between Fingerstick Whole Blood, Venous Whole Blood and Plasma Determined on the LumiraDx Point of Care D-Dimer and Point of Care CRP Tests to Results on the Reference Analyzer
Detailed description
The purpose of the study is to gather data to determine agreement between sample types, which together with performance evaluation data will be used to support CE marking under Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices 3, using ISO 13612:2002 - Performance Evaluation of In Vitro Diagnostic Medical Devices as the standard. The investigative devices are the LumiraDx Platform D Dimer Test and the LumiraDx Platform CRP Test. The LumiraDx Platform employs a portable diagnostic instrument used with single use D Dimer or CRP Assay Test Strips.
Agreement of the different sample types to the reference method will be demonstrated across a patient population representative of the indication for use of the products. Operators will be trained clinical site staff who are representative of the intended users of the product, i.e. health care professionals at the point of care such as nurses, technicians, doctors, etc. A panel of whole blood and plasma samples will be obtained from each patient in order to assess the accuracy of the investigative device across all sample types.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blood collection / CRP Cohort | – | Diagnostic Test: Venepuncture, Diagnostic Test: FingerstickVenepuncture and fingerstick to obtain venous blood and capillary blood respectively |
| Blood collection / D Dimer Cohort | – | Diagnostic Test: Venepuncture, Diagnostic Test: FingerstickVenepuncture and fingerstick to obtain venous blood and capillary blood respectively |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects >18 years old presenting to primary care provider with a variety of conditions as described in Inclusion/Exclusion criteria.
Key inclusion criteria (22 listed)
- Subjects >18 years of age.
- Willing and able to provide written informed consent and comply with study procedures.
- Presenting to healthcare provider for any reason* *All presentations are suitable for recruitment; however, the following conditions are of particular interest: Venous thromboembolism symptoms (DVT and Pulmonary embolism), subjects seeking medical attention with symptoms of respiratory tract infection (upper or lower), Acute myocardial infarction / unstable angina, Anti-inflammatory medication (current), Any regular medication for a chronic condition (other than simple painkiller or inhaler), Atrial fibrillation, Diabetes mellitus (all types except 'pre-diabetes'), Heart failure, Hypertension (>150/90), Infection (significant current or within 3 months), Peripheral arterial disease, Surgery (within 6 weeks), Childbirth (within 8 weeks), Significant trauma, burns (within 4 weeks), Pregnancy (confirmed or suspected), Acute upper gastrointestinal haemorrhage other significant recent haemorrhage.
- The subject is currently receiving or has received within the past thirty (30) days of the study visit an experimental biologic or drug including either treatment or therapy.
- Skin lesions or conditions that would preclude a fingerstick and or a venous blood draw.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| VenepunctureBlood tube will be collected from standard venepuncture | Diagnostic test | Blood collection / CRP Cohort, Blood collection / D Dimer Cohort |
| FingerstickCapillary blood will be collected by fingerstick | Diagnostic test | Blood collection / CRP Cohort, Blood collection / D Dimer Cohort |
Primary outcome
Assessment of sample matrix comparison
Time frame: 2 months
Verification that all sample types give an equivalent result when tested in the LumiraDx assays. Results generated from capillary blood and venous whole blood will be compared to those generated from plasma to ensure that all 3 sample types give equivalent values. Results will be compared by standard statisitical techniques which may include Regression analysis (e.g. Passing Bablok) or Bias analysis (e.g. Altman Bland)
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.
Judith Kirstein principal investigator
Rancho Paseo Medical Group
Matthew Morgan principal investigator
Centura Health Physician Group
Anita Scribner principal investigator
Diagnostic Clinic of Longview
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 Embolism and Thrombosis and Infection, 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 22 inclusion and 0 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?
Assessment of sample matrix comparison (time frame: 2 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.