A Study To Evaluate The Performance of the Lucira Health All-In-One COVID-19 Test Kit vs Hologic Panther Fusion
Completed · Not applicable
Conditions studied: Covid19, SARS (Severe Acute Respiratory Syndrome), Corona Virus Infection
In brief
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 assay. The results of this study will be used to demonstrate the Lucira COVID-19 'swab to result in 30 minutes' test kit is similar in performance to known high sensitivity best-in-class molecular assays performed in high complexity labs. The results of this study will be combined with other studies the Sponsor has underway and will support a FDA Emergency Use Authorization (EUA) of the Lucira COVID-19 All-In-One Test Kit. This performance study will include nasal swabs self-collected by study subjects at community-based locations with trained medical staff. A subject's participation in this study will consist of one study visit and one collection event. The subject self-collects a nasal swab sample according to Lucira COVID-19 Test Kit instructions and runs test according to Quick Reference Instructions (QRI). Following the Lucira COVID-19 All-In-One Test Kit self-collection will be an additional swab collection for reference method testing. One (1) additional NS specimen will be collected either by the health care professional or self-collection, prepared in Transport Medium and sent to a reference laboratory.
Key facts
- Study ID
- NCT04720794
- Run by
- Lucira Health Inc
- People needed
- 101
- Starts
- 2020-09-25
- Expected to finish
- 2020-10-20
- Last updated by the study team
- 2021-01-26
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
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
Where it is running
- Neeraj Kochhar Family Medicine — Los Gatos, California, United States
Full record on ClinicalTrials.gov
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