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

Overview

Performance of the LumiraDx SARS-CoV-2 Ag assay will be assessed by comparison to a reference method.

The study is a prospective, multi-center study. One (1) reference laboratory and approximately six (6) geographically diverse POC (Point of Care) locations (e.g. physician office laboratories, urgent cares, emergency departments, outpatient clinics, drive through testing sites or research centers) in the U.S. will participate in the study. Testing in the reference laboratory will be performed by trained laboratory personnel. Testing at the POC sites will be performed by non-laboratory health professionals who are representative of typical intended use operators (e.g. nurses, physician assistants, medical assistants, etc.). Each site will have a minimum of one (1) untrained intended use operator who will perform testing under this protocol. 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 will receive a unique study identification number. Subjects will have nasopharyngeal or nasal or throat swabs collected. Capillary blood may be collected alongside nasal swabs. Saliva samples may also be collected. Specimens will be obtained from each subject enrolled using standard collection methods. The LumiraDx SARS-CoV-2 Ag Test will be performed at POC sites by intended use operators (e.g. nurses, physician assistants, medical assistants, etc.). Each site will have a minimum of one (1) untrained intended use operator who will perform testing under this protocol. The LumiraDx SARS-CoV-2 Ag Test will be performed at the site on the same day as the date of collection using one swab for each subject enrolled. A central laboratory will perform reference testing. Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) will be estimated for the LumiraDx SARS-CoV-2 Ag Test results as compared with the reference Test. A minimum of thirty (30) positive SARS-CoV-2 are required, but it is likely because of the prevalence of SARS-CoV-2 in the population, that a greater number of negatives will be obtained during the prospective collection of positive samples; therefore, approximately four-hundred (400) subjects will be enrolled. A minimum of thirty (30) negative samples are required.

Conditions

Interventions

Eligibility

Locations (7)

Outcomes