NCT00863343

Clinical Validation of the Point-of-Care MSD Influenza Test

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 391 (actual)
• Sponsor: Meso Scale Diagnostics, LLC. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the performance of the MSD® Influenza Test in detecting influenza A and influenza B in subjects presenting with influenza-like-illness (ILI).

Detailed description

This is a multicenter, prospective study to evaluate the performance of the MSD Influenza Test for the detection and differentiation of influenza A (including A/H1, A/H3, and A/H5 subtypes) and influenza B. Nasal swabs from subjects presenting at the clinical care facility with ILI will be collected and tested on the MSD Influenza Test. Results from the Test will be compared to results obtained from viral culture performed on a second nasal swab at a reference laboratory.

Conditions

• Influenza Human

Interventions

Type	Name	Description
BIOLOGICAL	Public Health Notification	For any H5 positive results, notification of the result to the site's local public health authorities.

Timeline

• Start date: 2010-03-01
• Primary completion: 2010-07-01
• Completion: 2010-08-01
• First posted: 2009-03-18
• Last updated: 2012-03-01
• Results posted: 2012-03-01

Locations

3 sites across 1 country: United States