An interventional study of Lucira COVID-19 All-In-One test kit in Covid19 and Corona Virus Infection, sponsored by Lucira Health Inc. Completed at 1 site in United States. Open to participants aged 14 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-04-12.
Sponsored by Lucira Health Inc · Not applicable, Interventional, and Diagnostic
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.
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 304 is above the median of 100 across 4,098 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Lucira Health Inc is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria
Currently experiencing any of the CDC COVID-19 symptoms:
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
Study prevalence of SARS-CoV-2 will be summarized by counts and grouped by age
Time frame: 3 months
COVID-19 Prevalence Rate / Expected Values percentages
Study prevalence of SARS-CoV-2 will be summarized by percentages and grouped by age
Time frame: 3 Months
Collection Performance/ Incidence Rate counts
Study observations will be summarized by counts: * Self-Collection, Self-tested * User Experience
Time frame: 3 Months
Collection Performance/ Incidence Rate percentages
Study observations will be summarized by percentages: * Self-Collection, Self-tested * User Experience
Time frame: 3 Months
Sensitivity and specificity
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
Time frame: 3 Months
Invalid Rate
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
Time frame: 3 Months
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.