COVID-19: A POC Test Under Research & Evaluation

LumiraDx UK Limited2,000 enrolled

Overview

Collection of nasal/nasopharyngeal/throat swabs and blood samples from patients presenting at their designated care facility displaying symptoms of COVID-19 and undergoing a SOC SARS-CoV-2 test or those who have tested positive in the past to aid development, calibration and performance evaluation for the LumiraDx POC test.

CAPTURE is a two-stage sample collection study to complete the development, calibration and performance evaluation phases of the LumiraDx Point of Care (POC) device for the detection of the SARS-CoV-2 virus and the SARS-CoV-2 IgG/IgM status of infected patients. The study is split into two arms targeting separate populations throughout each stage. Stage 1: Consists of sample collection only, to facilitate the in-house development and calibration of the LumiraDx SARS-CoV-2 assays. Stage 2: Consists of sample collection to facilitate the performance evaluation of the LumiraDx SARS-CoV-2 studies. In this stage the testing will be completed onsite using the LumiraDx POC device.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

2,000

Conditions

COVID-19

Interventions

Sample Collection/Performance Evaluation (A)DIAGNOSTIC_TEST

This is a prospective sample collection and performance evaluation study which involves no therapeutic intervention. Sample types include: * Nasal/Throat/Nasal Throat Combo/ Nasopharyngeal (as per sites SOC) Swab * Whole Venous Blood

Sample Collection/Performance Evaluation (B)DIAGNOSTIC_TEST

This is a prospective sample collection and performance evaluation study which involves no therapeutic intervention. Sample types include: * Whole Venous Blood * Fingerstick Capillary Sample

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patient is at least 18 years of age. 2. Patient meets either of the below categories: 1. Patient is presenting with symptoms indicative of COVID-19 and will be completing SOC sampling for SARS-CoV-2 PCR testing. (Eligible for Arm A) 2. Patient has had a confirmed positive SARS-CoV-2 PCR test result in the past. (Eligible for Arm B) Exclusion Criteria: 1. The patient does not have the capacity to consent as determined by the Research Team (and the impartial witness if applicable). 2. The patient is deemed to be unsuitable for research at the research teams' discretion.

Locations (3)

Barts Health NHS Trust

London, United Kingdom

Homerton University Hospital NHS Foundation Trust

London, United Kingdom

University College London Hospitals NHS Foundation Trust

London, United Kingdom

Outcomes

Primary Outcomes

Performance of the LumiraDx Assay versus reference methods with regards to clinical sensitivity and specificity for the detection of the SARS-COV-2 IgG/IgM and viral antigen in patient samples.

Primary Outcome - To collect sufficient SARS-CoV-2 samples (nasal/nasopharyngeal/throat swabs and blood samples) to aid development, calibration and performance evaluation of the LumiraDx POC test. Results will be used to asses performance of the LumiraDx assay versus reference methods with regards to the clinical sensitivity and specificity for the detection of the SARS-COV-2 IgG/IgM and viral antigen in patient samples.

Time frame: 1 Year approx

Data from ClinicalTrials.gov

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