Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06141824 |
| Other study ID # |
09A-CLI-001 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 11, 2022 |
| Est. completion date |
February 16, 2023 |
Study information
| Verified date |
March 2024 |
| Source |
Lucira Health Inc |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The Lucira COVID-19& Flu Test is a single use (disposable) RT-LAMP test kit intended for the
simultaneous rapid in vitro qualitative detection and differentiation of SARS-CoV-2,
Influenza A, and Influenza B viral RNA in anterior nasal swab specimens.
The test consists of a nasal swab, a sample vial the nasal swab sample is placed in the
sample vial, containing the sample buffer, and the test unit, which detects whether
SARS-CoV-2, Influenza A, and Influenza B virus is present within the specimen during an acute
infection. The Lucira test uses a proprietary, molecular based process to detect the presence
of SARS-CoV-2, Influenza A, or Influenza B virus. The purpose of this study is to investigate
the Lucira COVID-19 & Flu Test for the in vitro qualitative detection and differentiation of
RNA from SARS-CoV-2, Influenza A, and Influenza B in nasal swab specimens from patients
suspected of COVID-19 or Influenza A or Influenza B. The primary objective is to test at
least 1000 self-collected nasal swab samples and to confirm the Lucira COVID-19 & Flu Test
provides similar accuracy to a high complexity lab molecular diagnostic RT-PCR assay(s) with
known high sensitivity for detecting SARS-CoV-2, Influenza A, and Influenza B virus.
Description:
The study is a prospective study with seven (7) sites in the U.S. participating in the study.
The Investigational device was tested on-site, and the comparator samples were sent to
reference laboratories in the U.S. Reference testing was performed by trained laboratory
personnel. This investigational device testing was performed in a simulated-home environment
with medical staff on site and included nasal swabs self-collected by study subjects per the
quick reference instructions (QRI).
A qualified research person was 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 were reviewed by an Institutional Review Board
(IRB) and written IRB approval was issued prior to enrollment of subjects into the study at
that site.
A subject's participation in this study consisted of a single visit. Following completion of
the informed consent process and a review of Inclusion/Exclusion criteria to determine
eligibility, each subject then received a unique study identification number. Subject
demographics including age, sex, race, ethnicity, education level, employment status, and
income was also collected at that time.
Two (2) swabs were collected for this study: One (1) nasal swab for the Lucira COVID-19 & Flu
Test and one (1) nasal swab for reference testing. These two study swabs were both collected
similarly as directed in the Lucira COVID-19 & Flu Test QRI. Any swab specimens required for
routine standard of care testing were collected prior to the specimens collected for this
investigation.
Subjects aged 14 years or older self-collected a nasal swab sample and ran the Lucira
COVID-19 Test according to QRI in the test kit. Nasal swab sample collection and testing for
Subjects ≥ 2 years but <14 years of age was assisted by a subject meeting the requirement for
self-collection. The subject was observed during the swabbing collection by the HCP and HCP
documented collection details and any collection issues. Nasal swabs obtained from
self-collection were discarded after having been used for testing per QRI. HCP interpreted
and documented results.
Following the Lucira COVID-19 Test self-collection an additional swab was collected for
reference method testing. One (1) additional NS specimen was collected by the health care
professional, prepared in Transport Medium, and sent for reference laboratory testing. Each
collection, the Lucira swab and reference swab, had a potential maximum of two swabs,
including retests, for a maximum of four swabs per visit.
Reference labs received study sample aliquots and tested samples against FDA emergency use
authorized SARS-CoV-2 and FDA cleared Influenza A&B Assays. Reference testing characterized
specimens as negative or positive for SARS-CoV-2 and Influenza A&B. Therefore, positive
percent agreement (PPA) and negative percent agreement (NPA) of the Lucira COVID-19 & Flu
Test was calculated by comparison with the respective reference methods.
Additional testing on remaining remnant aliquots may be performed to investigate any
discrepant and discordant results as needed by other FDA cleared/authorized molecular
methods.
At the end of the study, and at the Sponsor's discretion, residual remnant aliquots shall
remain at the reference laboratory, be destroyed/discarded, or returned to the Sponsor.
