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Evaluation of the LumiraDx Point of Care D-Dimer and CRP Tests (NOVEL-3)

Primary Purpose

Embolism and Thrombosis, Infection, Inflammation

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Venepuncture

Fingerstick

About this trial

This is an interventional diagnostic trial for Embolism and Thrombosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria D-dimer:

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.
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

Sites / Locations

Rancho Paseo Medical Group
Centura Health Physician Group
New Medical Healthcare
Diagnostic Clinic of Longview

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Blood collection

Arm Description

Venepuncture and fingerstick to obtain venous blood and capillary blood respectively

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

NCT ID

NCT04375982

First Posted

April 30, 2020

Last Updated

March 10, 2023

Sponsor

LumiraDx UK Limited

1. Study Identification

Unique Protocol Identification Number

NCT04375982

Brief Title

Evaluation of the LumiraDx Point of Care D-Dimer and CRP Tests

Acronym

NOVEL-3

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

April 20, 2020 (Actual)

Primary Completion Date

April 5, 2022 (Actual)

Study Completion Date

September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

LumiraDx UK Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief 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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Embolism and Thrombosis, Infection, Inflammation

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Subjects are asked to provide venous and capillary blood samples which are not being taken as part of routine care

Masking

None (Open Label)

Allocation

N/A

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Blood collection

Arm Type

Other

Arm Description

Venepuncture and fingerstick to obtain venous blood and capillary blood respectively

Intervention Type

Diagnostic Test

Intervention Name(s)

Venepuncture

Intervention Description

Blood tube will be collected from standard venepuncture

Intervention Type

Diagnostic Test

Intervention Name(s)

Fingerstick

Intervention Description

Capillary blood will be collected by fingerstick

Primary Outcome Measure Information:

Title

Assessment of sample matrix comparison

Description

Time Frame

2 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria D-dimer: 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. 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Judith Kirstein

Organizational Affiliation

Rancho Paseo Medical Group

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Matthew Morgan

Organizational Affiliation

Centura Health Physician Group

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Anita Scribner

Organizational Affiliation

Diagnostic Clinic of Longview

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

William Simon

Organizational Affiliation

New Medical Healthcare

Official's Role

Principal Investigator

Facility Information:

Facility Name

Rancho Paseo Medical Group

City

Banning

State/Province

California

ZIP/Postal Code

92220

Country

United States

Facility Name

Centura Health Physician Group

City

Northglenn

State/Province

Colorado

ZIP/Postal Code

80234

Country

United States

Facility Name

New Medical Healthcare

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67212

Country

United States

Facility Name

Diagnostic Clinic of Longview

City

Longview

State/Province

Texas

ZIP/Postal Code

75605

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Evaluation of the LumiraDx Point of Care D-Dimer and CRP Tests

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