Performance Evaluation of the Lucira COVID-19 & Flu Test

NCT06141824 | Completed Results FDA Device

• 1 other identifier: 09A-CLI-001
• Study Type: interventional
• Target: 1,361
• Locations: 1 country
• Sites: 7

Brief Summary

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.

Conditions

COVID-19; Influenza

Keywords

COVID-19; Influenza; COVID-19 test; Multiplex test; RT-LAMP; Molecular test; Single-use test

Outcome Measures

Primary Outcomes (1)

• 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 Percent Positive Agreement (PPA) ≥80%/Negative Positive Assessment (NPA) ≥98% for COVID-19 and PPA ≥90%/NPA ≥95% for Flu A\&B as compared to FDA emergency use authorized SARS-CoV-2 and FDA cleared Influenza A+B Assays. Two (2) swabs were collected for this study: One (1) anterior nasal swab (NS) for the Lucira COVID-19 and Flu Test and one (1) NS for reference testing. Reference testing characterized specimens as negative or positive for SARS-CoV-2 and Influenza A and B. Therefore, PPA and NPA of the Lucira COVID-19 and Flu Test were calculated by comparison with the respective reference methods. The data were analyzed via comparison to the comparator method in this protocol in a standard 2x2 table, with PPA and NPA calculated against the comparator. The percentage of the expected result was computed individually along with the associated 95% Wilson Score Confidence Interval \[1\] for each panel.

  Day 1

Study Arms (1)

Subject Self-Collection and Specimen Testing

EXPERIMENTAL

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 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

Interventions

Lucira COVID-19 & Flu Test DEVICE

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.

Subject Self-Collection and Specimen Testing

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Lucira Health Inc: lead

Study Sites (7)

Cullman Clinical Trials

Cullman, Alabama, 35055, United States

Location

Benchmark Research

Colton, California, 92324, United States

Location

Carbon Health

Oakland, California, 94610, United States

Location

Koch Family Medicine

Morton, Illinois, 61550, United States

Location

Lakeside Life Science

Plymouth, New Hampshire, 03264, United States

Location

Carbon Health

Eatontown, New Jersey, 07724, United States

Location

Benchmark Research

San Angelo, Texas, 76904, United States

Location

MeSH Terms

Conditions

COVID-19; Influenza, Human

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Orthomyxoviridae Infections

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2023
• First Posted: November 21, 2023
• Study Start: October 11, 2022
• Primary Completion: February 16, 2023
• Study Completion: February 16, 2023
• Last Updated: March 15, 2024
• Results First Posted: March 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)