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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Influenza Human

Intervention / Treatment
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* Biological: Public Health Notification


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Influenza infections, Orthomyxoviridae infections