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

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ClinicalTrials.gov Identifier: NCT04720235
Recruitment Status : Completed
First Posted : January 22, 2021
Last Update Posted : April 12, 2021
Sponsor:
Information provided by (Responsible Party):
Lucira Health Inc

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

Condition or disease Intervention/treatment Phase
Covid19 Corona Virus Infection Device: Lucira COVID-19 All-In-One test kit Not Applicable

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 are suspected of COVID-19 by their healthcare provider. The basis for this FDA EUA authorization was Lucira Health's first Community Testing study (07A-CLI-006) conducted among individuals suspected of COVID-19. This follow on 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 among asymptomatic individuals. The results of this study will be used to support an expanded indication for the Lucira COVID-19 All-In-One Test Kit among asymptomatic individuals.

This performance study will include the collection of subject demographics and nasal swabs self-collected by study subjects at community-based locations with trained medical staff oversight.

After determining subject eligibility and following the completion of the informed consent process, each subject will receive a unique study identification number.

A subject's participation in this study will consist of one study visit with one collection event. The subject self-collects a nasal swab sample and runs the Lucira COVID-19 All-In-One Test Kit according to the FDA EUA authorized package insert instructions.

Subject will be observed during the swabbing collection by the study staff and study staff will document collection details and any collection issues. Nasal swabs obtained from self-collection will be discarded after having been used for testing per the instructions. Study staff will interpret and share the Lucira COVID-19 All-In-One Test Kit result with study subjects.

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 self-collected, prepared in Transport Medium and sent to the reference laboratory as directed by the Study Operations Manual.

Each collection may have a maximum of two swabs, including retests, for a maximum of four swabs per visit.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 304 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Follow On Community Testing Study To Evaluate The Performance of the Lucira COVID-19 All-In-One Test Kit As Compared To The Hologic Panther Fusion SARS-CoV-2 RT-PCR Assay Among Asymptomatic Subjects
Actual Study Start Date : December 9, 2020
Actual Primary Completion Date : March 9, 2021
Actual Study Completion Date : March 30, 2021

Arm Intervention/treatment
Subject Self-Collection and Specimen Testing
Subjects will be provided with the Lucira COVID-19 Test Kit and collect one (1) nasal swab according to the QRI and test the sample on the Lucira COVID-19 All-In-One Test. HCP will observe subject during this process and document any observations and deviations from the QRI.
Device: Lucira COVID-19 All-In-One test kit

The Lucira COVID-19 All-In-One Test Kit is intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19 in nasal swab samples. This test is a single-use test kit that determines whether there is active shedding of the virus which causes COVID-19. This test utilizes a molecular amplification technology for the detection of SARS-CoV-2 RNA.

Positive results are indicative of active infection with SARS-CoV-2. Persons who test positive should self-isolate and seek care from their healthcare provider.

Negative results do not preclude SARS-CoV-2 infection. Persons who continue to experience COVID-like symptoms should seek follow up care from their healthcare provider





Primary Outcome Measures :
  1. COVID-19 Prevalence Rate / Expected Values counts [ Time Frame: 3 months ]
    Study prevalence of SARS-CoV-2 will be summarized by counts and grouped by age

  2. COVID-19 Prevalence Rate / Expected Values percentages [ Time Frame: 3 Months ]
    Study prevalence of SARS-CoV-2 will be summarized by percentages and grouped by age


Secondary Outcome Measures :
  1. Collection Performance/ Incidence Rate counts [ Time Frame: 3 Months ]

    Study observations will be summarized by counts:

    • Self-Collection, Self-tested
    • User Experience

  2. Collection Performance/ Incidence Rate percentages [ Time Frame: 3 Months ]

    Study observations will be summarized by percentages:

    • Self-Collection, Self-tested
    • User Experience

  3. Sensitivity and specificity [ Time Frame: 3 Months ]
    Sensitivity and specificity along with their associated 2-sided Wilson Score 95% Confidence Intervals will be estimated for SARS-CoV-2, on the Lucira COVID-19 All-In-One Test in comparison to the reference test


Other Outcome Measures:
  1. Invalid Rate [ Time Frame: 3 Months ]
    The invalid rates, along with their associated 2-sided Wilson Score 95% Confidence Intervals will be estimated for SARS-CoV-2 on the Lucira COVID-19 All-In-One Test



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   14 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

  1. Ages 14-75
  2. Must be able to read and write in English
  3. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04720235


Locations
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United States, California
Neeraj Kochhar Family Medicine
Los Gatos, California, United States, 95032
Sponsors and Collaborators
Lucira Health Inc
Investigators
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Principal Investigator: Neeraj Kochhar, MD Neeraj Kochhar Family Medicine
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Responsible Party: Lucira Health Inc
ClinicalTrials.gov Identifier: NCT04720235    
Other Study ID Numbers: 07A-CLI-007
First Posted: January 22, 2021    Key Record Dates
Last Update Posted: April 12, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Coronavirus Infections
Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections