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

Terminated

• Conditions: Influenza Human
• Interventions: Biological: Public Health Notification

• Registration Number: NCT00863343
• Lead Sponsor: Meso Scale Diagnostics, LLC.

Brief 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.

Study Timeline

• Study First Submitted: 2009-03-16
• Study First Submitted QC: 2009-03-16
• Study First Posted: 2009-03-18
• Study Start: 2010-03
• Primary Completion: 2010-07
• Study Completion: 2010-08
• Results First Submitted: 2011-08-05
• Status Verified: 2012-01
• Results First Submitted QC: 2012-01-30
• Last Update Submitted: 2012-01-30
• Results First Posted: 2012-03-01
• Last Update Posted: 2012-03-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 391

Inclusion Criteria

• Any subject (all ages) presenting with ILI (defined as fever [subjective or documented] and cough or sore throat), and suspected of having influenza.
• Subject (parent, guardian, or authorized legal representative) gives informed consent or assent (child) to the study, and provides signed authorization for use and disclosure of protected health information.

Exclusion Criteria

• Any subject classified as "high risk" for exposure to avian or novel influenza, as determined by a Risk-Assessment Questionnaire.
• Subjects who had prior nasal wash/aspirate or nasopharyngeal wash/aspirate specimens collected for routine health-care purposes within the same suspected influenza infection episode.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All	Public Health Notification	Anyone presenting with influenza-like-illness

Primary Outcome Measures

Name	Time	Method
MSD Influenza A Test Results Against Cell Culture	1 day	A nasal sample is tested on the MSD Influenza Test, which provides a positive or negative result. A separate nasal swab is tested by tissue cell culture, which provides a positive or negative result. These two results are then compared.
MSD Influenza B Test Results Against Cell Culture	1 day	A nasal sample is tested on the MSD Influenza Test, which provides a positive or negative result. A separate nasal swab is tested by tissue cell culture, which provides a positive or negative result. These two results are then compared, and PCR is performed on discrepant results and used to reconcile differences.
MSD Influenza B Test Results Against Culture and PCR	1 day	A nasal sample is tested on the MSD Influenza Test, which provides a positive or negative result. A separate nasal swab is tested by tissue cell culture, which provides a positive or negative result. These two results are then compared, and PCR is performed on discrepant results and used to reconcile differences.
MSD Influenza A Test Results Against Culture and PCR	1 day	A nasal sample is tested on the MSD Influenza Test, which provides a positive or negative result. A separate nasal swab is tested by tissue cell culture, which provides a positive or negative result. These two results are then compared, and PCR is performed on discrepant results and used to reconcile differences.

Trial Locations

Locations (3)

Naval Health Research Center; 🇺🇸 San Diego, California, United States

John T Mather Hospital; 🇺🇸 Port Jefferson, New York, United States

Dartmouth-Hitchcock Medical Center; 🇺🇸 Lebanon, New Hampshire, United States