Performance Evaluation of the Lucira COVID-19 & Flu Test

Completed · Not applicable

Conditions studied: COVID-19, Influenza

In brief

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.

Key facts

Study ID

NCT06141824

Run by

Lucira Health Inc

People needed

1361

Starts

2022-10-11

Expected to finish

2023-02-16

Last updated by the study team

2024-03-15

Who can join

Age: 2 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Cullman Clinical Trials — Cullman, Alabama, United States
• Benchmark Research — Colton, California, United States
• Carbon Health — Oakland, California, United States
• Koch Family Medicine — Morton, Illinois, United States
• Lakeside Life Science — Plymouth, New Hampshire, United States
• Carbon Health — Eatontown, New Jersey, United States
• Benchmark Research — San Angelo, Texas, United States

Full record on ClinicalTrials.gov

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