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

NCT04375982 | Unknown FDA Device

• 1 other identifier: S-CLIN-PROT-00027
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 4

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

Conditions

Embolism and Thrombosis; Infection; Inflammation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Blood collection

OTHER

Venepuncture and fingerstick to obtain venous blood and capillary blood respectively

Diagnostic Test: Venepuncture; Diagnostic Test: Fingerstick

Interventions

Venepuncture DIAGNOSTIC_TEST

Blood tube will be collected from standard venepuncture

Blood collection

Fingerstick DIAGNOSTIC_TEST

Capillary blood will be collected by fingerstick

Blood collection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.
• 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.

Sponsors & Collaborators

• LumiraDx UK Limited: lead

Study Sites (4)

Rancho Paseo Medical Group

Banning, California, 92220, United States

Location

Centura Health Physician Group

Northglenn, Colorado, 80234, United States

Location

New Medical Healthcare

Wichita, Kansas, 67212, United States

Location

Diagnostic Clinic of Longview

Longview, Texas, 75605, United States

Location

MeSH Terms

Conditions

Embolism and Thrombosis; Infections; Inflammation

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Judith Kirstein

  Rancho Paseo Medical Group

  PRINCIPAL INVESTIGATOR

• Matthew Morgan

  Centura Health Physician Group

  PRINCIPAL INVESTIGATOR

• Anita Scribner

  Diagnostic Clinic of Longview

  PRINCIPAL INVESTIGATOR

• William Simon

  New Medical Healthcare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: April 30, 2020
• First Posted: May 6, 2020
• Study Start: April 20, 2020
• Primary Completion: April 5, 2022
• Study Completion: March 31, 2024
• Last Updated: December 26, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)