NCT05268939

Performance Evaluation of the LumiraDx SARS-CoV-2 & FLU A/B and SARS-CoV-2 & RSV Tests for Aid in the Assessment of COVID-19

A Multicenter Study Conducted to Evaluate the Performance of the LumiraDx SARS-CoV-2 & FLU A/B Test, and LumiraDx SARS-CoV-2 & RSV Test at Point of Care Testing Sites

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 668 (actual)
• Sponsor: LumiraDx UK Limited · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

A Multicenter Study Conducted to Evaluate the Performance of the LumiraDx SARS-CoV-2 \& FLU A/B Test, and LumiraDx SARS-CoV-2 \& RSV Test at Point of Care Testing Sites. Subjects presenting with symptoms suggestive of COVID-19 and/or Influenza and/or RSV will be consented and asked to donate swab sample(s) for testing in the device(s) under evaluation.

Detailed description

Approximately one-thousand (1000) subjects will be enrolled in this study. Patients presenting to their health care professionals, drive through testing sites or research centers and meet the inclusion/exclusion criteria will be enrolled in the study. A subject's participation in this study will consist of a single visit. Following completion of the informed consent process and a review of Inclusion/Exclusion criteria to determine eligibility, each subject will receive a unique study identification number. The potential subject will be asked to provide relevant medical history information (i.e., regarding their influenza/RSV and or COVID-19-like symptoms), which will be evaluated against all inclusion and exclusion criteria depending in their cohort. A subject's SARS-CoV-2 vaccination status will also be collected including the doses, dates of vaccination and brand. Specimens will be obtained from each subject enrolled using standard collection methods. The objectives of this study are to: * Evaluate the performance of the LumiraDx SARS-CoV-2 \& Flu A/B Test in detecting SARS-CoV-2 and/ or influenza A or B in nasal and nasopharyngeal swabs from patients with signs and symptoms of COVID-19 or influenza as compared with an FDA EUA authorized or 510(k) comparative method. * Evaluate the performance of the LumiraDx SARS-CoV-2 \& RSV Test in detecting SARS-CoV-2 and/ or RSV in nasal and nasopharyngeal swabs from patients with signs and symptoms of COVID-19 or RSV as compared with an FDA EUA authorized or 510(k) comparative method. * Evaluate the point of care usability of the LumiraDx SARS-CoV-2 \& Flu A/B Test and LumiraDx SARS-CoV-2 \& RSV Test.

Conditions

• COVID-19
• Influenza A
• Influenza Type B
• RSV Infection

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	LumiraDx SARS-CoV-2 & Flu A/B test	Swab Samples for Diagnostic test
DIAGNOSTIC_TEST	LumiraDx SARS-CoV-2 & RSV test	Swab Samples for Diagnostic test

Timeline

• Start date: 2022-01-04
• Primary completion: 2022-04-25
• Completion: 2023-03-14
• First posted: 2022-03-07
• Last updated: 2023-08-14

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated device study