Influenza
Conditions
Keywords
Influenza infections, Orthomyxoviridae infections, Influenza Human
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).
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.
Interventions
BIOLOGICALLocal/Regional Public Health Notification
For any H5 positive results, notification of the result to the site's local/regional public health authorities.
Sponsors
Centers for Disease Control and Prevention
Meso Scale Diagnostics, LLC.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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 to the study, and provides signed authorization for use and disclosure of protected health information.
Exclusion criteria
* 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. * Unable to collect nasal and throat swab. * Severely ill patient without a family relative to provide informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the sensitivity and specificity of influenza A and B, and subtypes A/H1 and A/H3 with nasal and throat specimens for the MSD Influenza test as compared to cell culture and sequencing in a cross-section of the general population | 4 months |
Secondary
| Measure | Time frame |
|---|---|
| To determine the specificity of influenza subtype A/H5 in nasal and throat specimens for the MSD Influenza test as compared to cell culture and sequencing in a cross section of the general population. | 4 months |
Countries
Vietnam
Outcome results
None listed