Status:
COMPLETED
A Study To Evaluate The Performance of the Lucira Health All-In-One COVID-19 Test Kit vs Hologic Panther Fusion
Lead Sponsor:
Lucira Health Inc
Conditions:
Covid19
SARS (Severe Acute Respiratory Syndrome)
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
This Lucira COVID-19 All-In-One Test Kit performance study will be used to establish the performance of the Lucira COVID-19 All-In-One Test Kit as compared to a known high sensitivity RT-PCR molecular...
Detailed Description
The study is a prospective, single site study with community-based sampling in high COVID-19 prevalence communities in California. The Investigational device will be tested on-site and the reference s...
Eligibility Criteria
Inclusion
- Ages 18-75
- Must be able to read and write in English or Spanish
- Must be willing to try rapid COVID-19 test and self-collect a nasal swab sample in both nostrils
- Must be one of the following:
- Currently experiencing a Fever of 100﮲ Fahrenheit and above or self-reports having fever within the past 48 hours, and experiencing at least one (1) additional associated CDC COVID-19 symptom:
- Cough
- Shortness of breath or difficulty breathing
- Fatigue
- Muscle or body aches
- Headache
- New loss of taste or smell
- Sore throat
- Congestion or runny nose
- Nausea or vomiting
- Diarrhea
- Previously tested positive for COVID-19 in past 14 days, and experiencing at least one (1) additional associated CDC COVID-19 symptom
- Currently experiencing at least three (3) additional associated CDC COVID-19 symptoms so long as at least at least one (1) symptom is either: cough, shortness of breath, and/or new loss of taste or smell.
Exclusion
- Currently suffering from nasal trauma such as a nosebleed
- Received a nasal rinse/wash/aspirates for standard of care testing
Key Trial Info
Start Date :
September 25 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 20 2020
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT04720794
Start Date
September 25 2020
End Date
October 20 2020
Last Update
January 26 2021
Active Locations (1)
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1
Neeraj Kochhar Family Medicine
Los Gatos, California, United States, 95032