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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    Page 1 of 1 (1 locations)

    1

    Neeraj Kochhar Family Medicine

    Los Gatos, California, United States, 95032