Trial Outcomes & Findings for Performance Evaluation of the Lucira COVID-19 & Flu Test (NCT NCT06141824)
NCT ID: NCT06141824
Last Updated: 2024-03-15
Results Overview
The sensitivity and specificity endpoint are Percent Positive Agreement (PPA) ≥80%/Negative Positive Assessment (NPA) ≥98% for COVID-19 and PPA ≥90%/NPA ≥95% for Flu A\&B as compared to FDA emergency use authorized SARS-CoV-2 and FDA cleared Influenza A+B Assays. Two (2) swabs were collected for this study: One (1) anterior nasal swab (NS) for the Lucira COVID-19 and Flu Test and one (1) NS for reference testing. Reference testing characterized specimens as negative or positive for SARS-CoV-2 and Influenza A and B. Therefore, PPA and NPA of the Lucira COVID-19 and Flu Test were calculated by comparison with the respective reference methods. The data were analyzed via comparison to the comparator method in this protocol in a standard 2x2 table, with PPA and NPA calculated against the comparator. The percentage of the expected result was computed individually along with the associated 95% Wilson Score Confidence Interval \[1\] for each panel.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1361 participants
Primary outcome timeframe
Day 1
Results posted on
2024-03-15
Participant Flow
A total of 1366 research participants were consented to participate in the study, 5 participants were withdrawn from the study. 1361 participants were enrolled and participated in the study.
Participant milestones
| Measure |
Lucira COVID-19 & Flu Test
The Lucira COVID-19 (Coronavirus 2019) and Flu Test is a rapid, single-use, molecular test for the qualitative detection and discrimination of SARS-CoV-2, Influenza A, and Influenza B viral RNA in nasal swab samples. Participants self-collected an anterior nasal swab sample.
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|---|---|
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Overall Study
STARTED
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1361
|
|
Overall Study
Evaluable COVID-19 Results
|
1229
|
|
Overall Study
Evaluable Flu A Results
|
1333
|
|
Overall Study
Evaluable Flu B Results
|
1332
|
|
Overall Study
COMPLETED
|
1361
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
"Overall Number of Participants" signifies participants evaluable for COVID-19, Flu A and Flu B results respectively. "Number Analyzed" signifies number of participants evaluable for specified rows.
Baseline characteristics by cohort
| Measure |
Lucira COVID-19 & Flu Test
n=1361 Participants
The Lucira COVID-19 \& Flu Test is a rapid, single-use, molecular test for the qualitative detection and discrimination of SARS-CoV-2, Influenza A, and Influenza B viral RNA in nasal swab samples.
|
|---|---|
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Age, Customized
COVID-19 · 2-5 years
|
48 Participants
n=1229 Participants • "Overall Number of Participants" signifies participants evaluable for COVID-19, Flu A and Flu B results respectively. "Number Analyzed" signifies number of participants evaluable for specified rows.
|
|
Age, Customized
COVID-19 · 6-21 years
|
342 Participants
n=1229 Participants • "Overall Number of Participants" signifies participants evaluable for COVID-19, Flu A and Flu B results respectively. "Number Analyzed" signifies number of participants evaluable for specified rows.
|
|
Age, Customized
COVID-19 · 22-59 years
|
708 Participants
n=1229 Participants • "Overall Number of Participants" signifies participants evaluable for COVID-19, Flu A and Flu B results respectively. "Number Analyzed" signifies number of participants evaluable for specified rows.
|
|
Age, Customized
COVID-19 · >=60 years
|
131 Participants
n=1229 Participants • "Overall Number of Participants" signifies participants evaluable for COVID-19, Flu A and Flu B results respectively. "Number Analyzed" signifies number of participants evaluable for specified rows.
|
|
Age, Customized
Flu A · 2-5 years
|
52 Participants
n=1333 Participants • "Overall Number of Participants" signifies participants evaluable for COVID-19, Flu A and Flu B results respectively. "Number Analyzed" signifies number of participants evaluable for specified rows.
|
|
Age, Customized
Flu A · 6-21 years
|
377 Participants
n=1333 Participants • "Overall Number of Participants" signifies participants evaluable for COVID-19, Flu A and Flu B results respectively. "Number Analyzed" signifies number of participants evaluable for specified rows.
|
|
Age, Customized
Flu A · 22-59 years
|
763 Participants
n=1333 Participants • "Overall Number of Participants" signifies participants evaluable for COVID-19, Flu A and Flu B results respectively. "Number Analyzed" signifies number of participants evaluable for specified rows.
|
|
Age, Customized
Flu A · >=60 years
|
141 Participants
n=1333 Participants • "Overall Number of Participants" signifies participants evaluable for COVID-19, Flu A and Flu B results respectively. "Number Analyzed" signifies number of participants evaluable for specified rows.
|
|
Age, Customized
Flu B · 2-5 years
|
52 Participants
n=1332 Participants • "Overall Number of Participants" signifies participants evaluable for COVID-19, Flu A and Flu B results respectively. "Number Analyzed" signifies number of participants evaluable for specified rows.
|
|
Age, Customized
Flu B · 6-21 years
|
376 Participants
n=1332 Participants • "Overall Number of Participants" signifies participants evaluable for COVID-19, Flu A and Flu B results respectively. "Number Analyzed" signifies number of participants evaluable for specified rows.
|
|
Age, Customized
Flu B · 22-59 years
|
763 Participants
n=1332 Participants • "Overall Number of Participants" signifies participants evaluable for COVID-19, Flu A and Flu B results respectively. "Number Analyzed" signifies number of participants evaluable for specified rows.
|
|
Age, Customized
Flu B · >=60 years
|
141 Participants
n=1332 Participants • "Overall Number of Participants" signifies participants evaluable for COVID-19, Flu A and Flu B results respectively. "Number Analyzed" signifies number of participants evaluable for specified rows.
|
|
Sex/Gender, Customized
COVID-19 · Female
|
763 Participants
n=1229 Participants • "Overall Number of Participants" signifies participants evaluable for COVID-19, Flu A and Flu B results respectively. "Number Analyzed" signifies number of participants evaluable for specified rows.
|
|
Sex/Gender, Customized
COVID-19 · Male
|
465 Participants
n=1229 Participants • "Overall Number of Participants" signifies participants evaluable for COVID-19, Flu A and Flu B results respectively. "Number Analyzed" signifies number of participants evaluable for specified rows.
|
|
Sex/Gender, Customized
COVID-19 · Other
|
1 Participants
n=1229 Participants • "Overall Number of Participants" signifies participants evaluable for COVID-19, Flu A and Flu B results respectively. "Number Analyzed" signifies number of participants evaluable for specified rows.
|
|
Sex/Gender, Customized
Flu A · Female
|
834 Participants
n=1333 Participants • "Overall Number of Participants" signifies participants evaluable for COVID-19, Flu A and Flu B results respectively. "Number Analyzed" signifies number of participants evaluable for specified rows.
|
|
Sex/Gender, Customized
Flu A · Male
|
498 Participants
n=1333 Participants • "Overall Number of Participants" signifies participants evaluable for COVID-19, Flu A and Flu B results respectively. "Number Analyzed" signifies number of participants evaluable for specified rows.
|
|
Sex/Gender, Customized
Flu A · Other
|
1 Participants
n=1333 Participants • "Overall Number of Participants" signifies participants evaluable for COVID-19, Flu A and Flu B results respectively. "Number Analyzed" signifies number of participants evaluable for specified rows.
|
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Sex/Gender, Customized
Flu B · Female
|
834 Participants
n=1332 Participants • "Overall Number of Participants" signifies participants evaluable for COVID-19, Flu A and Flu B results respectively. "Number Analyzed" signifies number of participants evaluable for specified rows.
|
|
Sex/Gender, Customized
Flu B · Male
|
497 Participants
n=1332 Participants • "Overall Number of Participants" signifies participants evaluable for COVID-19, Flu A and Flu B results respectively. "Number Analyzed" signifies number of participants evaluable for specified rows.
|
|
Sex/Gender, Customized
Flu B · Other
|
1 Participants
n=1332 Participants • "Overall Number of Participants" signifies participants evaluable for COVID-19, Flu A and Flu B results respectively. "Number Analyzed" signifies number of participants evaluable for specified rows.
|
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Ethnicity (NIH/OMB)
COVID-19 · Hispanic or Latino
|
262 Participants
n=1229 Participants • "Overall Number of Participants" signifies participants evaluable for COVID-19, Flu A and Flu B results respectively. "Number Analyzed" signifies number of participants evaluable for specified rows.
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Ethnicity (NIH/OMB)
COVID-19 · Not Hispanic or Latino
|
955 Participants
n=1229 Participants • "Overall Number of Participants" signifies participants evaluable for COVID-19, Flu A and Flu B results respectively. "Number Analyzed" signifies number of participants evaluable for specified rows.
|
|
Ethnicity (NIH/OMB)
COVID-19 · Unknown or Not Reported
|
12 Participants
n=1229 Participants • "Overall Number of Participants" signifies participants evaluable for COVID-19, Flu A and Flu B results respectively. "Number Analyzed" signifies number of participants evaluable for specified rows.
|
|
Ethnicity (NIH/OMB)
Flu A · Hispanic or Latino
|
271 Participants
n=1333 Participants • "Overall Number of Participants" signifies participants evaluable for COVID-19, Flu A and Flu B results respectively. "Number Analyzed" signifies number of participants evaluable for specified rows.
|
|
Ethnicity (NIH/OMB)
Flu A · Not Hispanic or Latino
|
1044 Participants
n=1333 Participants • "Overall Number of Participants" signifies participants evaluable for COVID-19, Flu A and Flu B results respectively. "Number Analyzed" signifies number of participants evaluable for specified rows.
|
|
Ethnicity (NIH/OMB)
Flu A · Unknown or Not Reported
|
18 Participants
n=1333 Participants • "Overall Number of Participants" signifies participants evaluable for COVID-19, Flu A and Flu B results respectively. "Number Analyzed" signifies number of participants evaluable for specified rows.
|
|
Ethnicity (NIH/OMB)
Flu B · Hispanic or Latino
|
271 Participants
n=1332 Participants • "Overall Number of Participants" signifies participants evaluable for COVID-19, Flu A and Flu B results respectively. "Number Analyzed" signifies number of participants evaluable for specified rows.
|
|
Ethnicity (NIH/OMB)
Flu B · Not Hispanic or Latino
|
1043 Participants
n=1332 Participants • "Overall Number of Participants" signifies participants evaluable for COVID-19, Flu A and Flu B results respectively. "Number Analyzed" signifies number of participants evaluable for specified rows.
|
|
Ethnicity (NIH/OMB)
Flu B · Unknown or Not Reported
|
18 Participants
n=1332 Participants • "Overall Number of Participants" signifies participants evaluable for COVID-19, Flu A and Flu B results respectively. "Number Analyzed" signifies number of participants evaluable for specified rows.
|
|
Race/Ethnicity, Customized
COVID-19 · American Indian or Alaska Native
|
2 Participants
n=1229 Participants • Overall Number of Participants" signifies participants evaluable for COVID-19, Flu A and Flu B results respectively. "Number Analyzed" signifies number of participants evaluable for specified rows.
|
|
Race/Ethnicity, Customized
COVID-19 · Asian
|
16 Participants
n=1229 Participants • Overall Number of Participants" signifies participants evaluable for COVID-19, Flu A and Flu B results respectively. "Number Analyzed" signifies number of participants evaluable for specified rows.
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|
Race/Ethnicity, Customized
COVID-19 · Native Hawaiian or Other Pacific Islander
|
2 Participants
n=1229 Participants • Overall Number of Participants" signifies participants evaluable for COVID-19, Flu A and Flu B results respectively. "Number Analyzed" signifies number of participants evaluable for specified rows.
|
|
Race/Ethnicity, Customized
COVID-19 · Black or African American
|
57 Participants
n=1229 Participants • Overall Number of Participants" signifies participants evaluable for COVID-19, Flu A and Flu B results respectively. "Number Analyzed" signifies number of participants evaluable for specified rows.
|
|
Race/Ethnicity, Customized
COVID-19 · White
|
1112 Participants
n=1229 Participants • Overall Number of Participants" signifies participants evaluable for COVID-19, Flu A and Flu B results respectively. "Number Analyzed" signifies number of participants evaluable for specified rows.
|
|
Race/Ethnicity, Customized
COVID-19 · Other
|
25 Participants
n=1229 Participants • Overall Number of Participants" signifies participants evaluable for COVID-19, Flu A and Flu B results respectively. "Number Analyzed" signifies number of participants evaluable for specified rows.
|
|
Race/Ethnicity, Customized
COVID-19 · Unknown or Not Reported
|
15 Participants
n=1229 Participants • Overall Number of Participants" signifies participants evaluable for COVID-19, Flu A and Flu B results respectively. "Number Analyzed" signifies number of participants evaluable for specified rows.
|
|
Race/Ethnicity, Customized
Flu A · American Indian or Alaska Native
|
2 Participants
n=1333 Participants • Overall Number of Participants" signifies participants evaluable for COVID-19, Flu A and Flu B results respectively. "Number Analyzed" signifies number of participants evaluable for specified rows.
|
|
Race/Ethnicity, Customized
Flu A · Asian
|
18 Participants
n=1333 Participants • Overall Number of Participants" signifies participants evaluable for COVID-19, Flu A and Flu B results respectively. "Number Analyzed" signifies number of participants evaluable for specified rows.
|
|
Race/Ethnicity, Customized
Flu A · Native Hawaiian or Other Pacific Islander
|
2 Participants
n=1333 Participants • Overall Number of Participants" signifies participants evaluable for COVID-19, Flu A and Flu B results respectively. "Number Analyzed" signifies number of participants evaluable for specified rows.
|
|
Race/Ethnicity, Customized
Flu A · Black or African American
|
62 Participants
n=1333 Participants • Overall Number of Participants" signifies participants evaluable for COVID-19, Flu A and Flu B results respectively. "Number Analyzed" signifies number of participants evaluable for specified rows.
|
|
Race/Ethnicity, Customized
Flu A · White
|
1206 Participants
n=1333 Participants • Overall Number of Participants" signifies participants evaluable for COVID-19, Flu A and Flu B results respectively. "Number Analyzed" signifies number of participants evaluable for specified rows.
|
|
Race/Ethnicity, Customized
Flu A · Other
|
28 Participants
n=1333 Participants • Overall Number of Participants" signifies participants evaluable for COVID-19, Flu A and Flu B results respectively. "Number Analyzed" signifies number of participants evaluable for specified rows.
|
|
Race/Ethnicity, Customized
Flu A · Unknown or Not Reported
|
15 Participants
n=1333 Participants • Overall Number of Participants" signifies participants evaluable for COVID-19, Flu A and Flu B results respectively. "Number Analyzed" signifies number of participants evaluable for specified rows.
|
|
Race/Ethnicity, Customized
Flu B · American Indian or Alaska Native
|
2 Participants
n=1332 Participants • Overall Number of Participants" signifies participants evaluable for COVID-19, Flu A and Flu B results respectively. "Number Analyzed" signifies number of participants evaluable for specified rows.
|
|
Race/Ethnicity, Customized
Flu B · Asian
|
18 Participants
n=1332 Participants • Overall Number of Participants" signifies participants evaluable for COVID-19, Flu A and Flu B results respectively. "Number Analyzed" signifies number of participants evaluable for specified rows.
|
|
Race/Ethnicity, Customized
Flu B · Native Hawaiian or Other Pacific Islander
|
2 Participants
n=1332 Participants • Overall Number of Participants" signifies participants evaluable for COVID-19, Flu A and Flu B results respectively. "Number Analyzed" signifies number of participants evaluable for specified rows.
|
|
Race/Ethnicity, Customized
Flu B · Black or African American
|
62 Participants
n=1332 Participants • Overall Number of Participants" signifies participants evaluable for COVID-19, Flu A and Flu B results respectively. "Number Analyzed" signifies number of participants evaluable for specified rows.
|
|
Race/Ethnicity, Customized
Flu B · White
|
1205 Participants
n=1332 Participants • Overall Number of Participants" signifies participants evaluable for COVID-19, Flu A and Flu B results respectively. "Number Analyzed" signifies number of participants evaluable for specified rows.
|
|
Race/Ethnicity, Customized
Flu B · Other
|
28 Participants
n=1332 Participants • Overall Number of Participants" signifies participants evaluable for COVID-19, Flu A and Flu B results respectively. "Number Analyzed" signifies number of participants evaluable for specified rows.
|
|
Race/Ethnicity, Customized
Flu B · Unknown or Not Reported
|
15 Participants
n=1332 Participants • Overall Number of Participants" signifies participants evaluable for COVID-19, Flu A and Flu B results respectively. "Number Analyzed" signifies number of participants evaluable for specified rows.
|
PRIMARY outcome
Timeframe: Day 1Population: "Overall Number of Participants" signifies participants evaluable for COVID-19, Flu A and Flu B results respectively. "Number Analyzed" signifies number of participants evaluable for specified rows.
The sensitivity and specificity endpoint are Percent Positive Agreement (PPA) ≥80%/Negative Positive Assessment (NPA) ≥98% for COVID-19 and PPA ≥90%/NPA ≥95% for Flu A\&B as compared to FDA emergency use authorized SARS-CoV-2 and FDA cleared Influenza A+B Assays. Two (2) swabs were collected for this study: One (1) anterior nasal swab (NS) for the Lucira COVID-19 and Flu Test and one (1) NS for reference testing. Reference testing characterized specimens as negative or positive for SARS-CoV-2 and Influenza A and B. Therefore, PPA and NPA of the Lucira COVID-19 and Flu Test were calculated by comparison with the respective reference methods. The data were analyzed via comparison to the comparator method in this protocol in a standard 2x2 table, with PPA and NPA calculated against the comparator. The percentage of the expected result was computed individually along with the associated 95% Wilson Score Confidence Interval \[1\] for each panel.
Outcome measures
| Measure |
COVID-19
n=1229 Participants
Participants who were evaluable for COVID-19 results.
|
Flu A
n=1333 Participants
Participants who were evaluable for Flu A results.
|
Flu B
n=1332 Participants
Participants who were evaluable for Flu B results.
|
|---|---|---|---|
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Confirmation That the Lucira COVID-19 & Flu Test Provides Similar Performance to a High Complexity Lab Molecular Diagnostic RT-PCR Assay(s) With Known High Sensitivity
Percent Positive Agreement (PPA)
|
88.7 percentage of results matching PCR
Interval 82.4 to 92.9
|
90.2 percentage of results matching PCR
Interval 83.7 to 94.3
|
—
|
|
Confirmation That the Lucira COVID-19 & Flu Test Provides Similar Performance to a High Complexity Lab Molecular Diagnostic RT-PCR Assay(s) With Known High Sensitivity
Negative Positive Agreement (PPA)
|
99.7 percentage of results matching PCR
Interval 99.2 to 99.9
|
99.4 percentage of results matching PCR
Interval 98.8 to 99.7
|
99.9 percentage of results matching PCR
Interval 99.6 to 100.0
|
Adverse Events
Lucira COVID-19 & Flu Test
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER