Performance Evaluation of LumiraDx COVID-19 (SARS-CoV-2) Ag Test

Launched by LUMIRADX UK LIMITED · Sep 17, 2020

Keywords

ClinConnect Summary

This clinical trial is studying the LumiraDx COVID-19 test, which is designed to quickly detect the presence of the virus that causes COVID-19. The main goal is to see how well this test works compared to other established testing methods. The trial is currently active but not recruiting new participants, meaning they are not looking for more people to join at this time.

To be eligible for this study, participants can be of any age and gender, but they need to show signs of COVID-19 symptoms, such as fever, cough, or loss of taste, or have had a positive PCR test for the virus in the last 48 hours. Participants will need to provide written consent to join the study, and if they are under 18, a parent or guardian must consent for them. It's important to note that people who have recently undergone certain medical tests or treatments, or who have already participated in this study, cannot join. Overall, those who take part will help researchers understand how effective the LumiraDx test is in identifying COVID-19.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. The subject may be of any age and either sex.
• • 2. Preliminary assessment of the subject by the Investigator/designee should be suggestive of COVID-19 at the time of the study visit. The subject must present as symptomatic, meaning they have exhibited one or more of the following signs and symptoms for eligibility: fever, cough, shortness of breath, difficulty breathing, muscle pain, headache, sore throat, chills, repeated shaking with chills, new loss of taste or smell. The onset of these symptoms will be recorded.
• • or The subject must have a documented SARS-CoV-2 PCR test in the past 48 hours.
• • 3. Written informed consent must be obtained prior to study enrollment.
• • 1. A subject who is eighteen (18) years or older must be willing to give written informed consent and must agree to comply with study procedures.
• • 2. The Legal Guardian or Legal Authorized Representative of a subject who is under the age of eighteen (18) must give written informed consent and agree to comply with study procedures. Active written assent should be obtained from children of appropriate intellectual age (as defined by the IRB).
• Exclusion Criteria:
• • 1. The subject underwent a nasal wash/aspirate as part of standard of care testing during this study visit.
• • 2. The subject is currently receiving or has received within the past thirty (30) days of the study visit an experimental biologic, drug, or device including either treatment or therapy.
• • 3. The subject has previously participated in this research study