Clinical trial NCT04720235: A Follow On Community Testing Study To Evaluate The Performance of the Lucira COVID-19 All-In-One Test Kit
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Corona Virus Infection
Lead sponsor: Lucira Health Inc
Sponsor class: INDUSTRY
First posted: 2021-01-22
Enrollment: 304
Sex: ALL
Minimum age (years): 14
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility 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

Primary outcomes:
measure: COVID-19 Prevalence Rate / Expected Values counts
timeFrame: 3 months
measure: COVID-19 Prevalence Rate / Expected Values percentages
timeFrame: 3 Months
Secondary outcomes:
measure: Collection Performance/ Incidence Rate counts
timeFrame: 3 Months
measure: Collection Performance/ Incidence Rate percentages
timeFrame: 3 Months
measure: Sensitivity and specificity
timeFrame: 3 Months
Other outcomes:
measure: Invalid Rate
timeFrame: 3 Months
Locations:
city: Los Gatos
country: United States
facility: Neeraj Kochhar Family Medicine
state: California
Study officials:
affiliation: Neeraj Kochhar Family Medicine
name: Neeraj Kochhar, MD
role: PRINCIPAL_INVESTIGATOR
References: