A Study To Evaluate The Performance of the Lucira Health All-In-One COVID-19 Test Kit vs Hologic Panther Fusion
Condition: Covid19; SARS (Severe Acute Respiratory Syndrome); Corona Virus Infection
MeSH terms: COVID-19; Severe Acute Respiratory Syndrome; Coronavirus Infections
Study type: Interventional

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.
    

Detailed description: 
      The study is a prospective, single site study with community-based sampling in high COVID-19
      prevalence communities in California. The Investigational device will be tested on-site and
      the reference samples will be sent to one (1) reference laboratory in the U.S. Testing in the
      reference laboratory will be performed by trained laboratory personnel. This study, to be
      performed with medical staff on site, and will include nasal swabs self-collected by study
      subjects per the QRI.

      Community based sampling will be conducted only by trained medical study staff. Study staff
      will bring all study materials-the Lucira investigational device as well as the reference
      swab collection kit-to all subjects enrolled in the study. This mobile, outdoor,
      community-based sampling method will ensure that COVID-symptomatic persons with fever do not
      travel from their homes, thus risking exposure to others. All medical staff participating in
      the study will be under the oversight of the study Principal Investigators and wear
      appropriate PPE during community visits.

      A qualified research person will be designated as the Investigator at each site, with the
      responsibility for oversight of the study in accordance with Good Clinical Practice (GCP) and
      regulatory requirements. The protocol and subject informed consent will be reviewed by an
      Institutional Review Board (IRB) and written IRB approval will be issued prior to enrollment
      of subjects into the study at that site.

      A subject's participation in this study will consist of a single visit. Following completion
      of the informed consent process and a review of Inclusion/Exclusion criteria to determine
      eligibility, each subject will receive a unique study identification number. Subject
      demographics including age, sex, race, and ethnicity, will also be collected at this time.

      All subjects will be observed during the swabbing collection by the HCP and HCP will document
      collection details and any collection issues. The HCP will confirm the Lucira COVID-19 Test
      Kit is running and will interpret the test results once completed. Nasal swabs obtained from
      self-collection will be discarded after it has been used for testing.

      Following the Lucira COVID-19 Test Kit collection will be a collection for reference method
      testing. A reference swab should not be collected until the Lucira Test Kit is running. The
      nasal swab reference swab shall be collected in the same manner as the initial collection,
      prepared in Transport Medium and sent to the Sutter Shared Laboratory.

      To evaluate performance, all reference samples collected will be tested using EUA-cleared
      molecular method:

      • Hologic Panther Fusion SARS-CoV-2 RT-PCR Assay *

      Reference testing will characterize specimens as negative or positive for SARS-CoV-2.
      Therefore, sensitivity and specificity of the Lucira COVID-19 Test will be calculated by
      comparison with the reference methods.

      Additional testing on remaining remnant aliquots may be performed to investigate any
      discrepant and discordant results as needed, and samples may undergo additional testing by
      other EUA-cleared molecular methods. The Roche Cobas 6800 SARS-CoV-2 assay will be used for
      discrepant testing.

      If subject consents to storage and future testing of samples, any extra remnants at the end
      of the study will be returned to the Sponsor for storage.
    

Intervention name(s): Lucira COVID-19 All-In-One test kit
Intervention type(s): Device
Intervention description(s): 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
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic