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Trial record 75 of 648 for:    test AND point-of-care

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

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ClinicalTrials.gov Identifier: NCT00863343
Recruitment Status : Terminated (Funding of study was exhausted prior to completion of study)
First Posted : March 18, 2009
Results First Posted : March 1, 2012
Last Update Posted : March 1, 2012
Sponsor:
Collaborator:
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment
Influenza Human 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.

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Study Type : Observational
Actual Enrollment : 391 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Validation of the Point-of-Care MSD Influenza Test
Study Start Date : March 2010
Actual Primary Completion Date : July 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


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Ages Eligible for Study:   Child, Adult, Older Adult
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.

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
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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
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Study Director: Jacqueline Perodin, PhD, CCRP Meso Scale Diagnostics

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Responsible Party: Meso Scale Diagnostics, LLC.
ClinicalTrials.gov Identifier: NCT00863343     History of Changes
Other Study ID Numbers: MSD-ITPOC-01
First Posted: March 18, 2009    Key Record Dates
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:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases