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

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).

Study Overview

• Status: Terminated
• Conditions: Influenza Human
• Intervention / Treatment: Biological: Public Health Notification

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 Type: Observational
• Enrollment (Actual): 391

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92106
      • Naval Health Research Center
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth-Hitchcock Medical Center
  • New York
    • Port Jefferson, New York, United States, 11777
      • John T Mather Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Individuals visiting a primary care site.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
All; Anyone presenting with influenza-like-illness	Biological: Public Health Notification; For any H5 positive results, notification of the result to the site's local public health authorities.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MSD Influenza A Test Results Against Cell Culture	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.	1 day
MSD Influenza B Test Results Against Cell Culture	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.	1 day
MSD Influenza A Test Results Against Culture and PCR	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.	1 day
MSD Influenza B Test Results Against Culture and PCR	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.	1 day

Collaborators and Investigators

• Sponsor: Meso Scale Diagnostics, LLC.
• Collaborators: Centers for Disease Control and Prevention
• Investigators: Study Director: Jacqueline Perodin, PhD, CCRP, Meso Scale Diagnostics

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): July 1, 2010
• Study Completion (Actual): August 1, 2010

Study Registration Dates

• First Submitted: March 16, 2009
• First Submitted That Met QC Criteria: March 16, 2009
• First Posted (Estimate): March 18, 2009

Study Record Updates

• Last Update Posted (Estimate): March 1, 2012
• Last Update Submitted That Met QC Criteria: January 30, 2012
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Keywords: Orthomyxoviridae infections; Influenza infections
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human
• Other Study ID Numbers: MSD-ITPOC-01