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

NCT04720794 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2021-01-26

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Lucira Health Inc

    lead INDUSTRY

Principal Investigators

  • Neeraj Kochhar, MD · Neeraj Kochhar Family Medicine

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-25
Primary Completion
2020-10-20
Completion
2020-10-20
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04720794 on ClinicalTrials.gov