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COMPLETED
NCT05787444

Clinical Validation of the LumiraDx SARS-CoV-2 & Flu A/B Combo Test

Sponsor: LumiraDx UK Limited

View on ClinicalTrials.gov

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

DIAGNOSTIC_TEST

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