Research & Evaluation of LumiraDx SARS-CoV-2 (COVID-19) Point of Care Ab Test

Launched by LUMIRADX UK LIMITED · Oct 20, 2020

Keywords

ClinConnect Summary

This is a prospective, multi-centre study. One (1) Reference Lab and approximately six (6) Healthcare or Research Facilities within geographic areas experiencing current Covid-19 outbreaks in the U.S. will participate in the study. Study sites may be Point of Care (POC) locations, such as physician office laboratories, urgent care and outpatient clinics, or dedicated research sites.

A subject's participation in this study will consist of a single visit. Following completion of the informed consent process and a review of Inclusion/Exclusion criteria to determine eligibility, each subject w...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male and female subjects aged ≥ 2 years.
• • 2. The subject must have a documented SARS-CoV-2 PCR test in the past 7-30 days. (subjects must be 14+ days post symptom onset at the time of recruitment).
• • 3. Written informed consent must be obtained prior to study enrollment.
• • 1. A subject who is 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 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. Skin lesions or conditions that would preclude a fingerstick and or a venous blood draw.
• • 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.