Performance Evaluation of the Lucira COVID-19 & Flu Test

Study Overview
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Brief Summary
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The Lucira COVID-19& Flu Test is a real-time RT-LAMP test intended for the qualitative detection and differentiation of RNA from SARS-CoV-2, Influenza A and Influenza B in self-collected nasal swab samples. The test consists of a nasal swab, a sample vial the nasal swab sample is placed in to prepare the sample for testing, and a test unit which detects whether SARS-CoV-2, Influenza A, and Influenza B virus is present within the specimen. The Lucira test uses a proprietary, molecular based detection process to detect whether a person is actively shedding the genomic RNA from the 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 for SARS-CoV-2 and Influenza A&B as compared to FDA cleared/authorized SARS-CoV-2 and Influenza A&B Assays.

Detailed Description
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The study is a prospective study with a minimum of three (3) 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 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 Quick Reference Instructions 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 was an additional swab collection 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, PPA and 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, at Sponsor's discretion, residual remnant aliquots shall remain at the reference laboratory, be destroyed/discarded, or returned to the Sponsor.

Official Title
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Performance Evaluation of the Lucira COVID-19 & Flu Test Versus FDA Authorized SARS-CoV-2 and Influenza A&B Assays

Conditions
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COVID-19, Influenza

Intervention / Treatment
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* Device: Lucira COVID-19 & Flu Test


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Subject Self-Collection and Specimen Testing<br>A subject's participation in this study will consist of one study visit. The subject self-collects a nasal swab sample according to Lucira COVID- 19 & Flu Test instructions and runs test according to Quick Reference Instruction (QRI). Following the Lucira COVID-19 &Flu Test self-collection will be an additional swab collection for reference method testing. One (1) additional NS specimen will be collected by the healthcare professional, prepared in Transport Medium, and sent to the reference laboratory. | Device: Lucira COVID-19 & Flu Test<br>* The Lucira COVID-19& Flu Test is a rapid, single-use, molecular test for the qualitative detection and discrimination of SARS-CoV-2, Influenza A and Influenza B viral RNA in nasal swab samples.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Confirmation that the Lucira COVID-19& Flu Test provides similar performance to a high complexity lab molecular diagnostic RT-PCR assay(s) with known high sensitivity. | The sensitivity and specificity endpoint are PPA ≥80%/NPA ≥98% for COVID-19 and PPA ≥90%/NPA ≥95% for Flu A&B. | Until 1000 COVID-19, 30 Flu A and 30 Flu B positive samples have been tested - Up to 14 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, Influenza, COVID-19 test, Multiplex test, RT-LAMP, Molecular test, Single-use test