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

This study has been terminated.
(Funding of study was exhausted prior to completion of study)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Meso Scale Diagnostics, LLC.
ClinicalTrials.gov Identifier:
NCT00863343
First received: March 16, 2009
Last updated: January 30, 2012
Last verified: January 2012
  Purpose

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).


Condition Intervention
Influenza Human
Biological: Public Health Notification

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Validation of the Point-of-Care MSD Influenza Test

Resource links provided by NLM:


Further study details as provided by Meso Scale Diagnostics, LLC.:

Primary Outcome Measures:
  • MSD Influenza A Test Results Against Cell Culture [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   Samples With DNA

Viral transport media containing nasal swab extract.


Enrollment: 391
Study Start Date: March 2010
Study Completion Date: August 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Individuals visiting a primary care site.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00863343

Locations
United States, California
Naval Health Research Center
San Diego, California, United States, 92106
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New York
John T Mather Hospital
Port Jefferson, New York, United States, 11777
Sponsors and Collaborators
Meso Scale Diagnostics, LLC.
Investigators
Study Director: Jacqueline Perodin, PhD, CCRP Meso Scale Diagnostics
  More Information

No publications provided

Responsible Party: Meso Scale Diagnostics, LLC.
ClinicalTrials.gov Identifier: NCT00863343     History of Changes
Other Study ID Numbers: MSD-ITPOC-01
Study First Received: March 16, 2009
Results First Received: August 5, 2011
Last Updated: January 30, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Meso Scale Diagnostics, LLC.:
Influenza infections
Orthomyxoviridae infections

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 18, 2014