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

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

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.

Study Overview

• Status: Completed
• Conditions: Covid19; Corona Virus Infection
• Intervention / Treatment: Device: Lucira COVID-19 All-In-One test kit

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.

• Study Type: Interventional
• Enrollment (Actual): 304
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Gatos, California, United States, 95032
      • Neeraj Kochhar Family Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
COVID-19 Prevalence Rate / Expected Values counts	Study prevalence of SARS-CoV-2 will be summarized by counts and grouped by age	3 months
COVID-19 Prevalence Rate / Expected Values percentages	Study prevalence of SARS-CoV-2 will be summarized by percentages and grouped by age	3 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Collection Performance/ Incidence Rate counts	Study observations will be summarized by counts: Self-Collection, Self-tested; User Experience	3 Months
Collection Performance/ Incidence Rate percentages	Study observations will be summarized by percentages: Self-Collection, Self-tested; User Experience	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	3 Months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3 Months

Collaborators and Investigators

• Sponsor: Lucira Health Inc

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2020
• Primary Completion (Actual): March 9, 2021
• Study Completion (Actual): March 30, 2021

Study Registration Dates

• First Submitted: January 15, 2021
• First Submitted That Met QC Criteria: January 20, 2021
• First Posted (Actual): January 22, 2021

Study Record Updates

• Last Update Posted (Actual): April 12, 2021
• Last Update Submitted That Met QC Criteria: April 9, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Coronavirus Infections
• Other Study ID Numbers: 07A-CLI-007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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