Finding studies
Finding studies
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Lead
LumiraDx UK Limited
Approximately two thousand (2000) subjects will be enrolled in this study. Patients presenting to the study sites that meet the eligibility criteria will be considered for the study. A subject's participation in this study will consist of a single on-site 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. Specimens will be obtained from each subject enrolled using standard collection methods. The objectives of this study are to evaluate and validate the performance of: * LumiraDx SARS-CoV-2 Ag Ultra test in detecting SARS-CoV-2 from symptomatic patients as compared with a Food and Drug Administration (FDA) cleared reverse transcription-polymerase chain reaction (RT-PCR) test. * LumiraDx SARS-CoV-2 \& Flu A/B tests in detecting SARS-CoV-2, Flu A, and/or Flu B from symptomatic patients as compared with an FDA cleared RT-PCR test for SARS-CoV-2 and an FDA cleared RT-PCR test for Flu A and Flu B.
Age
Any age
Sex
ALL
Healthy volunteers
Accepted
