Clinical Validation of the Point-of-Care MSD Influenza Test
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).
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.
Study Design
Observational Model: Cohort, Time Perspective: Prospective
Conditions
Influenza Human
Location
Naval Health Research Center
San Diego
California
United States
92106
Status
Recruiting
Source
Meso Scale Diagnostics, LLC.
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00863343
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Influenza B Virus
Species of the genus INFLUENZAVIRUS B that cause HUMAN INFLUENZA and other diseases primarily in humans. Antigenic variation is less extensive than in type A viruses (INFLUENZA A VIRUS) and consequently there is no basis for distinct subtypes or variants. Epidemics are less likely than with INFLUENZA A VIRUS and there have been no pandemics. Previously only found in humans, Influenza B virus has been isolated from seals which may constitute the animal reservoir from which humans are exposed.
Influenza A Virus, H1n2 Subtype
A subtype of INFLUENZA A VIRUS comprised of the surface proteins hemagglutinin 1 and neuraminidase 2. It is endemic in both human and pig populations.
Influenza A Virus, H7n3 Subtype
A subtype of INFLUENZA A VIRUS comprised of the surface proteins hemagglutinin 7 and neuraminidase 3. It was first detected in turkeys in Britain in 1963 and there have been several outbreaks on poultry farms since that time. A couple cases of human infections have been reported.
Hemagglutinin Glycoproteins, Influenza Virus
Membrane glycoproteins from influenza viruses which are involved in hemagglutination, virus attachment, and envelope fusion. Fourteen distinct subtypes of HA glycoproteins and nine of NA glycoproteins have been identified from INFLUENZA A VIRUS; no subtypes have been identified for Influenza B or Influenza C viruses.
Influenza A Virus, H9n2 Subtype
A subtype of INFLUENZA A VIRUS comprised of the surface proteins hemagglutinin 9 and neuraminidase 2. The H9N2 subtype usually infects domestic birds (POULTRY) but there have been some human infections reported.
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