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Clinical Validation of the LumiraDx SARS-CoV-2 & Flu A/B Test in Detecting and Differentiating Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), Influenza A (Flu A), and/or Influenza B (Flu B)

NCT05787444 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1500

Last updated 2023-05-08

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • LumiraDx UK Limited

    lead INDUSTRY

Principal Investigators

  • Randall Quinn, MD · Cullman Clinical Trials

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-01
Primary Completion
2023-06-01
Completion
2023-06-20
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05787444 on ClinicalTrials.gov