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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:
ClinicalTrials.gov Identifier:
NCT00863343
First Posted: March 18, 2009
Last Update Posted: March 1, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Meso Scale Diagnostics, LLC.
  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 ]
    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 ]
    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 ]
    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 ]
    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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.
Centers for Disease Control and Prevention
Investigators
Study Director: Jacqueline Perodin, PhD, CCRP Meso Scale Diagnostics
  More Information

Responsible Party: Meso Scale Diagnostics, LLC.
ClinicalTrials.gov Identifier: NCT00863343     History of Changes
Other Study ID Numbers: MSD-ITPOC-01
First Submitted: March 16, 2009
First Posted: March 18, 2009
Results First Submitted: August 5, 2011
Results First Posted: March 1, 2012
Last Update Posted: March 1, 2012
Last Verified: January 2012

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