Status:
COMPLETED
Performance Evaluation of the Lucira COVID-19 & Flu Test
Lead Sponsor:
Lucira Health Inc
Conditions:
COVID-19
Influenza
Eligibility:
All Genders
2+ years
Phase:
NA
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 Infl...
Detailed Description
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 laborator...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 11 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 16 2023
Estimated Enrollment :
1361 Patients enrolled
Trial Details
Trial ID
NCT06141824
Start Date
October 11 2022
End Date
February 16 2023
Last Update
March 15 2024
Active Locations (7)
Enter a location and click search to find clinical trials sorted by distance.
1
Cullman Clinical Trials
Cullman, Alabama, United States, 35055
2
Benchmark Research
Colton, California, United States, 92324
3
Carbon Health
Oakland, California, United States, 94610
4
Koch Family Medicine
Morton, Illinois, United States, 61550