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NCT06141824 · ClinicalTrials.gov registry record · NA
Performance Evaluation of the Lucira COVID-19 & Flu Test
A NA study, sponsored by Lucira Health.
- Completed
- Registry status
- NA
- Development phase
- 1,361
- Enrollment target
NCT06141824 is a NA study that has completed, run by Lucira Health. The registered enrollment target is 1,361 participants.
The verdict
NCT06141824, a NA study, has completed, sponsored by Lucira Health.
- COMPLETED
- Registry status
- NA
- Development phase
- 1,361 participants
- Enrollment target
Study 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.
Interventions
- DEVICE Lucira COVID-19 & Flu Test
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,361 participants |
| Start Date | 2022-10-11 |
| Est. Completion | 2023-02-16 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06141824
The ClinicalTrials.gov registry entry for NCT06141824 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 1,361 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Lucira Health, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Lucira COVID-19 & Flu Test is the first listed.
NCT06141824 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06141824 about?
NCT06141824 is a clinical study titled "Performance Evaluation of the Lucira COVID-19 & Flu Test". 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 via...
What is the current status of trial NCT06141824?
This trial is currently completed. It is a NA study. The enrollment target is 1,361 participants. The study started on 2022-10-11. Estimated completion is 2023-02-16.
What interventions are being tested in trial NCT06141824?
The interventions under investigation include: Lucira COVID-19 & Flu Test (DEVICE).
Who is sponsoring clinical trial NCT06141824?
This trial is sponsored by Lucira Health, which has 3 total clinical trials registered on ClinicalTrials.gov.
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