NCT01089816

Rapid Diagnostic Test for Influenza

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 569 (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

Interventions

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

Timeline

• Start date: 2010-03-01
• Primary completion: 2010-08-01
• Completion: 2010-10-01
• First posted: 2010-03-19
• Last updated: 2015-04-21

Locations

4 sites across 1 country: Vietnam