Ignite Creation Date:
2024-05-06 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06141824
Status:
COMPLETED
Last Update Posted:
2024-03-15
First Post:
2023-08-03
Brief Title:
Performance Evaluation of the Lucira COVID-19 Flu Test
Sponsor:
Lucira Health Inc
Organization:
Lucira Health Inc
Study Overview
Official Title:
Performance Evaluation of the Lucira COVID-19 Flu Test Versus FDA Authorized SARS-CoV-2 and Influenza AB Assays
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 assays with known high sensitivity for detecting SARS-CoV-2 Influenza A and Influenza B virus
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 assays with known high sensitivity for detecting SARS-CoV-2 Influenza A and Influenza B virus
Detailed Description:
The study is a prospective study with seven 7 sites in the US participating in the study The Investigational device was tested on-site and the comparator samples were sent to reference laboratories in the US 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 subjects participation in this study consisted of a single visit Following completion of the informed consent process and a review of InclusionExclusion 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 AB Assays Reference testing characterized specimens as negative or positive for SARS-CoV-2 and Influenza AB 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 clearedauthorized molecular methods
At the end of the study and at the Sponsors discretion residual remnant aliquots shall remain at the reference laboratory be destroyeddiscarded or returned to the Sponsor
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 subjects participation in this study consisted of a single visit Following completion of the informed consent process and a review of InclusionExclusion 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 AB Assays Reference testing characterized specimens as negative or positive for SARS-CoV-2 and Influenza AB 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 clearedauthorized molecular methods
At the end of the study and at the Sponsors discretion residual remnant aliquots shall remain at the reference laboratory be destroyeddiscarded or returned to the Sponsor
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None