A Follow On Community Testing Study To Evaluate The Performance of the Lucira COVID-19 All-In-One Test Kit

Completed · Not applicable

Conditions studied: Covid19, Corona Virus Infection

In brief

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 sensitivity EUA RT-PCR among asymptomatic individuals. The comparator assay for this study is the Hologic Panther Fusion SARS-CoV-2 RT-PCR Assay.

Key facts

Study ID

NCT04720235

Run by

Lucira Health Inc

People needed

304

Starts

2020-12-09

Expected to finish

2021-03-30

Last updated by the study team

2021-04-12

Who can join

Age: 14 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Neeraj Kochhar Family Medicine — Los Gatos, California, United States

Full record on ClinicalTrials.gov

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