A Follow On Community Testing Study To Evaluate The Performance of the Lucira COVID-19 All-In-One Test Kit
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04720235|
Recruitment Status : Completed
First Posted : January 22, 2021
Last Update Posted : April 12, 2021
|Condition or disease||Intervention/treatment||Phase|
|Covid19 Corona Virus Infection||Device: Lucira COVID-19 All-In-One test kit||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||304 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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
- 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
- Collection Performance/ Incidence Rate counts [ Time Frame: 3 Months ]
Study observations will be summarized by counts:
- Self-Collection, Self-tested
- User Experience
- Collection Performance/ Incidence Rate percentages [ Time Frame: 3 Months ]
Study observations will be summarized by percentages:
- Self-Collection, Self-tested
- User Experience
- 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
- 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
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
|United States, California|
|Neeraj Kochhar Family Medicine|
|Los Gatos, California, United States, 95032|
|Principal Investigator:||Neeraj Kochhar, MD||Neeraj Kochhar Family Medicine|