Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed NA study, sponsored by Lucira Health.
NCT06141824 is a NA study that has completed, run by Lucira Health. The registered enrollment target is 1,361 participants, roughly in line with the 1,404-participant average among 58,714 other NA trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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 an
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 |
What the finished NCT06141824 record still lists
NCT06141824 is an interventional study that assigns participants to a tested intervention. Its 1,361 participants enrollment target places it among the larger protocols in the corpus, roughly in line with the 1,404-participant average among 58,714 other NA trials with a reported enrollment target.
The record links to 0 conditions, and to 1 intervention - of which Lucira COVID-19 & Flu Test is the first listed.
NCT06141824 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06141824's enrollment target sits among peer trials
1,361 73rd of 2000 higher than 1,928 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05245227 · 1,358 participants · Phase 3
Double Simultaneous Uterotonic Agents Versus Single Agent Regimen to Prevent Early Postpartum Hemorrhage
- NCT02677064 · 1,365 participants
Identify Barriers to Allogeneic Hematopoietic Stem Cell Transplantation in Patients With Newly Diagnosed and Relapsed Acute Leukemia
- NCT04489238 · 1,366 participants
Collection of Information to Better Understand Young Onset Colorectal Cancer
- NCT07256392 · 1,370 participants · Phase 3
Long-term Efficacy and Safety Extension (LTE) Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI