A Follow On Community Testing Study To Evaluate The Performance of the Lucira COVID-19 All-In-One Test Kit
Condition: Covid19; Corona Virus Infection
MeSH terms: COVID-19; Coronavirus Infections
Study type: Interventional

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.
    

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.
    

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