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