Performance Evaluation of the Lucira COVID-19 & Flu Test

The Lucira COVID-19\& Flu Test is a single use (disposable) RT-LAMP test kit intended for the simultaneous rapid in vitro qualitative detection and differentiation of SARS-CoV-2, Influenza A, and Influenza B viral RNA in anterior nasal swab specimens.

The test consists of a nasal swab, a sample vial the nasal swab sample is placed in the sample vial, containing the sample buffer, and the test unit, which detects whether SARS-CoV-2, Influenza A, and Influenza B virus is present within the specimen during an acute infection. The Lucira test uses a proprietary, molecular based process to detect the presence of SARS-CoV-2, Influenza A, or Influenza B virus. The purpose of this study is to investigate the Lucira COVID-19 \& Flu Test for the in vitro qualitative detection and differentiation of RNA from SARS-CoV-2, Influenza A, and Influenza B in nasal swab specimens from patients suspected of COVID-19 or Influenza A or Influenza B. The primary objective is to test at least 1000 self-collected nasal swab samples and to confirm the Lucira COVID-19 \& Flu Test provides similar accuracy to a high complexity lab molecular diagnostic RT-PCR assay(s) with known high sensitivity for detecting SARS-CoV-2, Influenza A, and Influenza B virus.

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.

Eligibility Criteria:
Inclusion Criteria:

* Individuals aged 14 years and older (self-collected) or individuals less than 14 years old but ≥ 2 years old (collected by an adult)
* Human subjects suspected of respiratory viral infection consistent with COVID-19 or Influenza by their healthcare provider within 4 days of symptom onset
* Must be willing to try Lucira COVID-19 \& Flu test with an anterior nasal (nasal) swab specimen collected from both nostrils
* Subject information shall include: gender, age, collection date, collection time, race, ethnicity, temperature, signs/symptoms, date of symptom onset, symptom severity, vaccination status, household income, education status, employment status, routine test data (results, methodology, date of collection, if available)

Exclusion Criteria:

* Currently suffering from nasal trauma such as a nosebleed
* Received a nasal rinse/wash/aspirates for standard of care testing
* The subject is undergoing treatment for COVID-19 or Flu currently and/or within the past 14 days of the study visit, including but not limited to: inhaled influenza vaccine (FluMist®) or flu antiviral medication, which may include but is not limited to Amantadine (Symmetrel®), Rimantadine (Flumadine®), Zanamivir (Relenza®), Oseltamivir (Tamiflu®), or Baloxavir marboxil (Xofluza®).
* The subject is currently receiving or has received within the past 30 days of the study visit an experimental biologic, drug, or device including either treatment or therapy.
* The subject has previously participated in this research study
* Incorrect comparator swab type or transport media
* Incorrect specimen handling
* Subjects not consented