The study is a prospective study with seven (7) sites in the U.S. participating in the
study. The Investigational device was tested on-site, and the comparator samples were
sent to reference laboratories in the U.S. Reference testing was performed by trained
laboratory personnel. This investigational device testing was performed in a
simulated-home environment with medical staff on site and included nasal swabs
self-collected by study subjects per the quick reference instructions (QRI).

A qualified research person was designated as the Investigator at each site with the
responsibility for oversight of the study in accordance with Good Clinical Practice (GCP)
and regulatory requirements.

The protocol and subject informed consent were reviewed by an Institutional Review Board
(IRB) and written IRB approval was issued prior to enrollment of subjects into the study
at that site.

A subject's participation in this study consisted of a single visit. Following completion
of the informed consent process and a review of Inclusion/Exclusion criteria to determine
eligibility, each subject then received a unique study identification number. Subject
demographics including age, sex, race, ethnicity, education level, employment status, and
income was also collected at that time.

Two (2) swabs were collected for this study: One (1) nasal swab for the Lucira COVID-19 &
Flu Test and one (1) nasal swab for reference testing. These two study swabs were both
collected similarly as directed in the Lucira COVID-19 & Flu Test QRI. Any swab specimens
required for routine standard of care testing were collected prior to the specimens
collected for this investigation.

Subjects aged 14 years or older self-collected a nasal swab sample and ran the Lucira
COVID-19 Test according to QRI in the test kit. Nasal swab sample collection and testing
for Subjects ≥ 2 years but <14 years of age was assisted by a subject meeting the
requirement for self-collection. The subject was observed during the swabbing collection
by the HCP and HCP documented collection details and any collection issues. Nasal swabs
obtained from self-collection were discarded after having been used for testing per QRI.
HCP interpreted and documented results.

Following the Lucira COVID-19 Test self-collection an additional swab was collected for
reference method testing. One (1) additional NS specimen was collected by the health care
professional, prepared in Transport Medium, and sent for reference laboratory testing.
Each collection, the Lucira swab and reference swab, had a potential maximum of two
swabs, including retests, for a maximum of four swabs per visit.

Reference labs received study sample aliquots and tested samples against FDA emergency
use authorized SARS-CoV-2 and FDA cleared Influenza A&B Assays. Reference testing
characterized specimens as negative or positive for SARS-CoV-2 and Influenza A&B.
Therefore, positive percent agreement (PPA) and negative percent agreement (NPA) of the
Lucira COVID-19 & Flu Test was calculated by comparison with the respective reference
methods.

Additional testing on remaining remnant aliquots may be performed to investigate any
discrepant and discordant results as needed by other FDA cleared/authorized molecular
methods.

At the end of the study, and at the Sponsor's discretion, residual remnant aliquots shall
remain at the reference laboratory, be destroyed/discarded, or returned to the Sponsor.