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Clinical Validation of the LumiraDx SARS-CoV-2 & Flu A/B Combo Test
Sponsor: LumiraDx UK Limited
Summary
This is a prospective multicenter study conducted to evaluate the performance of the LumiraDx SARS-CoV-2 \& Flu A/B tests at point of care sites. Subjects presenting with symptoms suggestive of coronavirus disease 2019 (COVID-19) and Influenza at the time of the study visit will be enrolled and asked to donate swab sample(s) for testing on the device under evaluation.
Official title: Clinical Validation of the LumiraDx SARS-CoV-2 & Flu A/B Test in Anterior Nares Nasal Samples For Point-of-Care (POC) Use
Key Details
Gender
All
Age Range
2 Years - Any
Study Type
OBSERVATIONAL
Enrollment
1081
Start Date
2023-05-04
Completion Date
2024-04-02
Last Updated
2026-06-11
Healthy Volunteers
No
Interventions
LumiraDx SARS-CoV-2 & Flu A/B
The LumiraDx SARS-CoV-2 \& Flu A/B test is an automated rapid microfluidic immunofluorescence assay for use with the LumiraDx Platform, for near-patient testing, intended for the qualitative and differential detection of nucleocapsid viral antigens from SARS-CoV-2, influenza A, and influenza B in an anterior nares sample (from both nostrils) collected by a healthcare professional for individuals aged 2 years and older. The test is authorized for individuals with symptoms of COVID-19, influenza A and B within the first 6 days of symptom onset.
Locations (1)
Cullman Clinical Trials
Cullman, Alabama, United States