This Lucira COVID-19 All-In-One Test Kit recently received FDA Emergency Use Authorization (EUA) for prescription home use with self-collected nasal swab samples in individuals aged 14 and older who are suspected of COVID-19 by their healthcare provider. The basis for this FDA EUA authorization was Lucira Health's first Community Testing study (07A-CLI-006) conducted among individuals suspected of COVID-19. This follow on performance study will be used to establish the performance of the Lucira COVID-19 All-In-One Test Kit as compared to a known high sensitivity RT-PCR molecular assay among asymptomatic individuals. The results of this study will be used to support an expanded indication for the Lucira COVID-19 All-In-One Test Kit among asymptomatic individuals.~This performance study will include the collection of subject demographics and nasal swabs self-collected by study subjects at community-based locations with trained medical staff oversight.~After determining subject eligibility and following the completion of the informed consent process, each subject will receive a unique study identification number.~A subject's participation in this study will consist of one study visit with one collection event. The subject self-collects a nasal swab sample and runs the Lucira COVID-19 All-In-One Test Kit according to the FDA EUA authorized package insert instructions.~Subject will be observed during the swabbing collection by the study staff and study staff will document collection details and any collection issues. Nasal swabs obtained from self-collection will be discarded after having been used for testing per the instructions. Study staff will interpret and share the Lucira COVID-19 All-In-One Test Kit result with study subjects.~Following the Lucira COVID-19 All-In-One Test Kit self-collection will be an additional swab collection for reference method testing. One (1) additional NS specimen will be self-collected, prepared in Transport Medium and sent to the reference laboratory as directed by the Study Operations Manual.~Each collection may have a maximum of two swabs, including retests, for a maximum of four swabs per visit.
To evaluate the performance of the FDA EUA authorized Lucira COVID-19 All-In-One Test Kit for the qualitative detection of SARS-CoV-2 virus in nasal swab samples as compared to a known high sensitivity EUA RT-PCR among asymptomatic individuals. The comparator assay for this study is the Hologic Panther Fusion SARS-CoV-2 RT-PCR Assay.