A Performance Evaluation of the LumiraDx Point of Care CRP Assay (REACT)

A Performance Evaluation of the LumiraDx Point of Care CRP Assay.

In patients with symptoms of infection, tissue injury and inflammatory disorders the study will evaluate agreement between the CRP measurements from the LumiraDx POC CRP assay and the Siemens Dimension Xpand Plus CRP assay, as an aid in evaluation and detection of infection, tissue injury and inflammatory disorders.

Study Overview

• Status: Completed
• Conditions: Infections; Inflammation; Tissue Injury
• Intervention / Treatment: Diagnostic test: Venepuncture; Diagnostic test: Fingerstick

Detailed Description

This is a performance evaluation study designed to assess the precision and accuracy of the LumiraDx point of Care (POC) C-reactive Protein (CRP) test when used in patients presenting with symptoms of infection, tissue injury or inflammatory disorder.

The LumiraDx POC CRP test is a quantitative immunoassay providing results in under 10 minutes. The accuracy of the LumiraDx POC CRP test will be assessed using capillary whole blood, venous blood, and plasma samples, by comparison to the CRP results obtained from the same individuals as analysed by trained laboratory professionals using the reference device, Siemens Dimension Xpand Plus CRP assay. The results of this study are intended to be used for regulatory filings for use as an in vitro diagnostic test in the UK, European Union (EU) and other relevant geographies.

Adults (aged 18 and over at time of consent) presenting to the study sites with symptoms of infection, tissue injury or inflammatory disorder will be included in the study. Approximately 250 patients will be recruited to ensure that sufficient suitable patients are enrolled and to allow for a small level of exclusions.

After obtaining informed consent, blood tube samples will be drawn and fingerstick samples of capillary blood will be taken from the subject, these will be applied directly onto unique test strips for immediate measurement of CRP on the LumiraDx POC instrument.

The CRP results obtained via the LumiraDx CRP test will be used in a set of comparative analyses designed to determine the performance characteristics of the test. This study is an observational, cross-sectional design. As an observational study of an investigative device, results obtained during the course of the study will not inform or alter patient management or treatment decisions in any way.

• Study Type: Interventional
• Enrollment (Actual): 79
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Edinburgh, United Kingdom
    • Royal Infirmary Edinburgh
  • London, United Kingdom
    • University College London Hospital
  • London, United Kingdom
    • St Georges Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients 18 years and over at the time of consent
• Willing and able to provide written informed consent and comply with study procedures
• Presenting with symptoms of infection, tissue injury, inflammatory disorders. This includes but not limited to : respiratory tract infection (upper and lower), rheumatoid arthritis, Lupus, burns, trauma, inflammatory bowel disease.

Exclusion Criteria:

• The patient 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.
• Patient has previously participated in this study
• Any patient with critical illness or requiring a time critical intervention
• Patient with end of life or palliative care
• Patient suffering from the following conditions: Myeloma, monoclonal gammopathy, extreme lipaemia
• Patient is deemed medically unfit to participate.

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
Experimental: Symptoms of inflammation, Infection, tissue injury; Venous blood draw of up to 24mL and up to 6 capillary fingersticks	Diagnostic test: Venepuncture; Venous blood draw; Diagnostic test: Fingerstick; Capillary blood draw

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To determine the performance of the LumiraDx POC CRP assay when compared to the Siemens Dimension Xpand Plus CRP in patients with symptoms of infection, inflammation, or injury.	Measurement of blood samples from patients with symptoms of inflammation, infection or injury in a reference method and in the LumiraDx method to assess accuracy of the LumiraDx method	2 months

Collaborators and Investigators

• Sponsor: LumiraDx UK Limited
• Investigators: Principal Investigator: Alasdair Gray, MD, NHS Lothian; Principal Investigator: James Harnett, University College London Hospital NHS Foundation Trust; Principal Investigator: Phil Moss, St Georges University Hospitals NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2021
• Primary Completion (Actual): January 11, 2022
• Study Completion (Actual): May 30, 2023

Study Registration Dates

• First Submitted: December 17, 2021
• First Submitted That Met QC Criteria: December 17, 2021
• First Posted (Actual): January 6, 2022

Study Record Updates

• Last Update Posted (Estimated): December 19, 2023
• Last Update Submitted That Met QC Criteria: December 18, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID Numbers: S-CLIN-PROT-00008

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: No