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

NCT04720235 | Completed FDA Device

• 1 other identifier: 07A-CLI-007
• Study Type: interventional
• Target: 304
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19; 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: 14 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Ages 14-75
• Must be able to read and write in English
• Must be willing to try rapid COVID-19 test and self-collect a nasal swab sample in both nostrils

You may not qualify if:

• 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

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; 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: January 15, 2021
• First Posted: January 22, 2021
• Study Start: December 9, 2020
• Primary Completion: March 9, 2021
• Study Completion: March 30, 2021
• Last Updated: April 12, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)