An observational study in Influenza A, Influenza B, sponsored by Quidel Corporation. Completed at 5 sites in United States. Per ClinicalTrials.gov, last updated 2018-03-20.
Sponsored by Quidel Corporation · Observational
Demonstrate improved clinical performance of visually read QuickVue Influenza A+B test.
The objective of this study is to demonstrate an improved clinical performance of the visually read QuickVue Influenza A+B test with nasal and nasopharyngeal swab specimens. Clinical performance will be based on comparison of QuickVue results to either cell culture or an FDA-cleared molecular test at one or more Reference Laboratories.
Subjects will be recruited from the general population as they present to the clinical facility. Subjects must have had a fever within the last two days and exhibiting one or more symptoms characteristic of influenza
Subjects will be recruited from the general population as they present to the clinical facility. Subjects must have had a fever within the last two days and exhibiting one or more symptoms characteristic of influenza. They must meet the following criteria to be eligible for enrollment:
Must also be currently exhibiting one or more of the following symptoms characteristic of influenza-like-illness (ILI).
Exclusion Criteria:
Has undergone treatment with anti-influenza antivirals within the previous 7 days, to include but not be limited to, Amantadine, Rimantadine, Ribavirin, Oseltamivir, Zanamivir or any other antiviral currently available in these classes.
Rapid diagnostic test with IVD, QuickVue Influenza A+B
Influenza Diagnostic test result
rapid IVD test
Time frame: 10 minutes
Plan to share: No
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This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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Quidel Corporation