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

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04408066

Acronym

CAPTURE

Enrollment

523

Registered

2020-05-29

Start date

2020-05-01

Completion date

2020-05-26

Last updated

2026-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19

Keywords

POC, IVD, SARS-CoV-2, IgG, IgM, Antigen, Antibody

Brief 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.

Interventions

DIAGNOSTIC_TESTSample 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_TESTSample 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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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.	1 Year approx	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.

Countries

United Kingdom

Contacts

PRINCIPAL_INVESTIGATORSamer Elkhodair

University College London Hospitals

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 16, 2026