Trials / Suspended
SuspendedNCT04408066
COVID-19: A POC Test Under Research & Evaluation
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
- Status
- Suspended
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 2,000 (estimated)
- Sponsor
- LumiraDx UK Limited · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | Sample Collection/Performance Evaluation (A) | 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 |
| DIAGNOSTIC_TEST | Sample Collection/Performance Evaluation (B) | This is a prospective sample collection and performance evaluation study which involves no therapeutic intervention. Sample types include: * Whole Venous Blood * Fingerstick Capillary Sample |
Timeline
- Start date
- 2020-04-30
- Primary completion
- 2024-07-01
- Completion
- 2024-07-01
- First posted
- 2020-05-29
- Last updated
- 2024-01-12
Locations
3 sites across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT04408066. Inclusion in this directory is not an endorsement.