Status:
COMPLETED
A Follow On Community Testing Study To Evaluate The Performance of the Lucira COVID-19 All-In-One Test Kit
Lead Sponsor:
Lucira Health Inc
Conditions:
Covid19
Corona Virus Infection
Eligibility:
All Genders
14-75 years
Phase:
NA
Brief Summary
To evaluate the performance of the FDA EUA authorized Lucira COVID-19 All-In-One Test Kit for the qualitative detection of SARS-CoV-2 virus in nasal swab samples as compared to a known high sensitivit...
Detailed Description
This Lucira COVID-19 All-In-One Test Kit recently received FDA Emergency Use Authorization (EUA) for prescription home use with self-collected nasal swab samples in individuals aged 14 and older who a...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Ages 14-75
- Must be able to read and write in English
- Must be willing to try rapid COVID-19 test and self-collect a nasal swab sample in both nostrils
- Exclusion Criteria
- Currently suffering from nasal trauma such as a nosebleed
- Received a nasal rinse/wash/aspirates in past 12 hours
- Currently experiencing any of the CDC COVID-19 symptoms:
- Fever
- Cough
- Shortness of breath or difficulty breathing
- Fatigue
- New loss of taste or smell
- Muscle or body aches
- Headache
- Sore throat
- Congestion or runny nose
- Nausea or vomiting
- Diarrhea
Exclusion
Key Trial Info
Start Date :
December 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 30 2021
Estimated Enrollment :
304 Patients enrolled
Trial Details
Trial ID
NCT04720235
Start Date
December 9 2020
End Date
March 30 2021
Last Update
April 12 2021
Active Locations (1)
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1
Neeraj Kochhar Family Medicine
Los Gatos, California, United States, 95032