A Study To Evaluate The Performance of the Lucira Health All-In-One COVID-19 Test Kit vs Hologic Panther Fusion

Overview

This Lucira COVID-19 All-In-One Test Kit 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. The results of this study will be used to demonstrate the Lucira COVID-19 'swab to result in 30 minutes' test kit is similar in performance to known high sensitivity best-in-class molecular assays performed in high complexity labs. The results of this study will be combined with other studies the Sponsor has underway and will support a FDA Emergency Use Authorization (EUA) of the Lucira COVID-19 All-In-One Test Kit. This performance study will include nasal swabs self-collected by study subjects at community-based locations with trained medical staff. A subject's participation in this study will consist of one study visit and one collection event. The subject self-collects a nasal swab sample according to Lucira COVID-19 Test Kit instructions and runs test according to Quick Reference Instructions (QRI). 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 collected either by the health care professional or self-collection, prepared in Transport Medium and sent to a reference laboratory.

The study is a prospective, single site study with community-based sampling in high COVID-19 prevalence communities in California. The Investigational device will be tested on-site and the reference samples will be sent to one (1) reference laboratory in the U.S. Testing in the reference laboratory will be performed by trained laboratory personnel. This study, to be performed with medical staff on site, and will include nasal swabs self-collected by study subjects per the QRI. Community based sampling will be conducted only by trained medical study staff. Study staff will bring all study materials-the Lucira investigational device as well as the reference swab collection kit-to all subjects enrolled in the study. This mobile, outdoor, community-based sampling method will ensure that COVID-symptomatic persons with fever do not travel from their homes, thus risking exposure to others. All medical staff participating in the study will be under the oversight of the study Principal Investigators and wear appropriate PPE during community visits. A qualified research person will be 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 will be reviewed by an Institutional Review Board (IRB) and written IRB approval will be issued prior to enrollment of subjects into the study at that site. 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. Subject demographics including age, sex, race, and ethnicity, will also be collected at this time. All subjects will be observed during the swabbing collection by the HCP and HCP will document collection details and any collection issues. The HCP will confirm the Lucira COVID-19 Test Kit is running and will interpret the test results once completed. Nasal swabs obtained from self-collection will be discarded after it has been used for testing. Following the Lucira COVID-19 Test Kit collection will be a collection for reference method testing. A reference swab should not be collected until the Lucira Test Kit is running. The nasal swab reference swab shall be collected in the same manner as the initial collection, prepared in Transport Medium and sent to the Sutter Shared Laboratory. To evaluate performance, all reference samples collected will be tested using EUA-cleared molecular method: • Hologic Panther Fusion SARS-CoV-2 RT-PCR Assay \* Reference testing will characterize specimens as negative or positive for SARS-CoV-2. Therefore, sensitivity and specificity of the Lucira COVID-19 Test will be calculated by comparison with the reference methods. Additional testing on remaining remnant aliquots may be performed to investigate any discrepant and discordant results as needed, and samples may undergo additional testing by other EUA-cleared molecular methods. The Roche Cobas 6800 SARS-CoV-2 assay will be used for discrepant testing. If subject consents to storage and future testing of samples, any extra remnants at the end of the study will be returned to the Sponsor for storage.