N/A
N=1,361
Performance Evaluation of the Lucira COVID-19 & Flu Test
COVID-19 · Influenza
Bottom Line
View on ClinicalTrials.gov: NCT06141824 ↗Enrolled (actual)
1,361
Serious AEs
0.0%
Results posted
Mar 2024
Primary outcome: Primary: 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 — 88.7; 90.2; 99.7; 99.4 percentage of results matching PCR
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Lucira COVID-19 & Flu Test (Device)
- Age
- Pediatric, Adult, Older Adult · 2+ yrs
- Sex
- All
- Sponsor
- Lucira Health Inc
- Primary completion
- Feb 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
88.7; 90.2; 99.7; 99.4; 99.9 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Individuals aged 14 years and older (self-collected) or individuals less than 14 years old but ≥ 2 years old (collected by an adult)
- Human subjects suspected of respiratory viral infection consistent with COVID-19 or Influenza by their healthcare provider within 4 days of symptom onset
- Must be willing to try Lucira COVID-19 & Flu test with an anterior nasal (nasal) swab specimen collected from both nostrils
- Subject information shall include: gender, age, collection date, collection time, race, ethnicity, temperature, signs/symptoms, date of symptom onset, symptom severity, vaccination status, household income, education status, employment status, routine test data (results, methodology, date of collection, if available)
Exclusion Criteria
- Currently suffering from nasal trauma such as a nosebleed
- Received a nasal rinse/wash/aspirates for standard of care testing
- The subject is undergoing treatment for COVID-19 or Flu currently and/or within the past 14 days of the study visit, including but not limited to: inhaled influenza vaccine (FluMist®) or flu antiviral medication, which may include but is not limited to Amantadine (Symmetrel®), Rimantadine (Flumadine®), Zanamivir (Relenza®), Oseltamivir (Tamiflu®), or Baloxavir marboxil (Xofluza®).
- The subject is currently receiving or has received within the past 30 days of the study visit an experimental biologic, drug, or device including either treatment or therapy.
- The subject has previously participated in this research study
- Incorrect comparator swab type or transport media
- Incorrect specimen handling
- Subjects not consented
Data sourced from ClinicalTrials.gov (NCT06141824). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.