NCT04288921

Evaluation of Performance of the LumiraDx Influenza A/B + RSV Test at POC Testing Sites

A Multicenter Study Conducted to Evaluate the Performance of the LumiraDx Influenza A/B + RSV Test at Point of Care Testing Sites

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,000 (estimated)
• Sponsor: LumiraDx UK Limited · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

A Multicenter Study Conducted to Evaluate the Performance of the LumiraDx Influenza A/B + RSV Test at Point of Care Testing Sites

Detailed description

The LumiraDx Influenza A/B + RSV Test is a rapid microfluidic immunofluorescence assay for use with the LumiraDx instrument for the qualitative detection and differentiation of Influenza type A, Influenza type B and respiratory syncytial virus (RSV) viral antigens. The test is not intended to detect influenza C antigens. The LumiraDx Influenza A/B + RSV assay uses nasal swabs or nasopharyngeal swab specimens, collected from symptomatic patients. Approximately 2000 subjects will be enrolled in this study. 120 influenza A positive, 120 influenza B positive and 120 RSV positive samples are required, in addition to at least 120 samples negative for influenza and 120 negative RSV samples, representing four (4) age groups: ≤ 5 years, 6 to 21 years, 22 to 59 years, and ≥ 60 years. Depending on the prevalence of influenza A, influenza B or RSV, it will be necessary to collect a significantly higher number of total samples to obtain the required number of positives. Banked specimens may be used to supplement the data set. The objectives of this clinical study are twofold: * Evaluate the performance of the LumiraDx Influenza A/B + RSV Test in detecting and differentiating influenza A, influenza B and RSV in fresh nasal or nasopharyngeal swab specimens from patients with signs and symptoms of influenza and or RSV-like illness, as compared with an FDA-cleared comparative method. * Evaluate LumiraDx Influenza A/B + RSV Test performance when the test is run by non-laboratory users in point-of-care (POC) locations representative of sites who perform testing under a CLIA certificate of waiver.

Conditions

• Influenza, Human
• Respiratory Syncytial Virus Infections

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Swab	Swab samples for diagnostic test

Timeline

• Start date: 2020-02-06
• Primary completion: 2023-09-30
• Completion: 2023-09-30
• First posted: 2020-02-28
• Last updated: 2023-03-13

Locations

20 sites across 1 country: United States

Regulatory

• FDA-regulated device study