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.
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
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
Neeraj Kochhar Family Medicine
Los Gatos, California, United States
Neeraj Kochhar, MD, Principal Investigator
Neeraj Kochhar Family Medicine