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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Inflammation; Embolism and Thrombosis; Infection
• Intervention / Treatment: Diagnostic test: Venepuncture; Diagnostic test: Fingerstick

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 Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Banning, California, United States, 92220
      • Rancho Paseo Medical Group
  • Colorado
    • Northglenn, Colorado, United States, 80234
      • Centura Health Physician Group
  • Kansas
    • Wichita, Kansas, United States, 67212
      • New Medical Healthcare
  • Texas
    • Longview, Texas, United States, 75605
      • Diagnostic Clinic of Longview

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Blood collection; Venepuncture and fingerstick to obtain venous blood and capillary blood respectively	Diagnostic test: Venepuncture; Blood tube will be collected from standard venepuncture; Diagnostic test: Fingerstick; Capillary blood will be collected by fingerstick

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	2 months

Collaborators and Investigators

• Sponsor: LumiraDx UK Limited
• Investigators: Principal Investigator: Judith Kirstein, Rancho Paseo Medical Group; Principal Investigator: Anita Scribner, Diagnostic Clinic of Longview; Principal Investigator: Matthew Morgan, Centura Health Physician Group; Principal Investigator: William Simon, New Medical Healthcare

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2020
• Primary Completion (Actual): April 5, 2022
• Study Completion (Estimated): March 31, 2024

Study Registration Dates

• First Submitted: April 30, 2020
• First Submitted That Met QC Criteria: May 1, 2020
• First Posted (Actual): May 6, 2020

Study Record Updates

• Last Update Posted (Actual): December 26, 2023
• Last Update Submitted That Met QC Criteria: December 22, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Embolism; Inflammation; Thrombosis; Embolism and Thrombosis
• Other Study ID Numbers: S-CLIN-PROT-00027

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No