COVID-19: A POC Test Under Research & Evaluation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Specimen Collection for Development and Performance Evaluation of the LumiraDx Platform Point of Care Tests for Sars-Cov-2 IgG/IgM & Antigen to be Used as an Aid in Diagnosis of COVID-19

Conditions
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COVID-19

Intervention / Treatment
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* Diagnostic Test: Sample Collection/Performance Evaluation (A)
* Diagnostic Test: Sample Collection/Performance Evaluation (B)


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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A Sample Collection & Performance Evaluation Study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A:Suspected COVID-19 patients<br>Arm A: Suspected COVID-19 Patients - SARS-CoV-2 viral antigen test swab and blood sample for SARS-CoV-2 IgG/IgM | Diagnostic Test: Sample Collection/Performance Evaluation (A)<br>* 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<br>|
| Experimental: Arm B: Previously positive COVID-19 patients<br>Arm B: Previously Positive COVID-19 patients - SARS-CoV-2 IgG/IgM blood sample. Capillary fingerstick samples will additionally be collected in Stage 2. | Diagnostic Test: Sample Collection/Performance Evaluation (B)<br>* This is a prospective sample collection and performance evaluation study which involves no therapeutic intervention. Sample types include: Whole Venous Blood Fingerstick Capillary Sample<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 Year approx | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Antigen, POC, IVD, SARS-CoV-2, IgG, IgM, Antibody