A Study To Evaluate The Performance of the Lucira Health All-In-One COVID-19 Test Kit vs Hologic Panther Fusion

NCT04720794 | Completed FDA Device

• 1 other identifier: 07A-CLI-006
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief Summary

This Lucira COVID-19 All-In-One Test Kit 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. The results of this study will be used to demonstrate the Lucira COVID-19 'swab to result in 30 minutes' test kit is similar in performance to known high sensitivity best-in-class molecular assays performed in high complexity labs. The results of this study will be combined with other studies the Sponsor has underway and will support a FDA Emergency Use Authorization (EUA) of the Lucira COVID-19 All-In-One Test Kit. This performance study will include nasal swabs self-collected by study subjects at community-based locations with trained medical staff. A subject's participation in this study will consist of one study visit and one collection event. The subject self-collects a nasal swab sample according to Lucira COVID-19 Test Kit instructions and runs test according to Quick Reference Instructions (QRI). 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 collected either by the health care professional or self-collection, prepared in Transport Medium and sent to a reference laboratory.

Conditions

Covid19; SARS (Severe Acute Respiratory Syndrome); Corona Virus Infection

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Collection Performance/ Incidence Rate counts

  3 Months

• Collection Performance/ Incidence Rate percentages

  3 Months

• Sensitivity and specificity

  3 Months

Other Outcomes (1)

• Invalid Rate

  3 Months

Study Arms (1)

Subject Self-Collection and Specimen Testing

OTHER

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

Interventions

Lucira COVID-19 All-In-One test kit DEVICE

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

Subject Self-Collection and Specimen Testing

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ages 18-75
• Must be able to read and write in English or Spanish
• Must be willing to try rapid COVID-19 test and self-collect a nasal swab sample in both nostrils
• Must be one of the following:
• Currently experiencing a Fever of 100﮲ Fahrenheit and above or self-reports having fever within the past 48 hours, and experiencing at least one (1) additional associated CDC COVID-19 symptom:
• Cough
• Shortness of breath or difficulty breathing
• Fatigue
• Muscle or body aches
• Headache
• New loss of taste or smell
• Sore throat
• Congestion or runny nose
• Nausea or vomiting
• Diarrhea

You may not qualify if:

• Currently suffering from nasal trauma such as a nosebleed
• Received a nasal rinse/wash/aspirates for standard of care testing

Sponsors & Collaborators

• Lucira Health Inc: lead

Study Sites (1)

Neeraj Kochhar Family Medicine

Los Gatos, California, 95032, United States

Location

MeSH Terms

Conditions

COVID-19; Severe Acute Respiratory Syndrome; Coronavirus Infections

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Neeraj Kochhar, MD

  Neeraj Kochhar Family Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2020
• First Posted: January 22, 2021
• Study Start: September 25, 2020
• Primary Completion: October 20, 2020
• Study Completion: October 20, 2020
• Last Updated: January 26, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)