Influenza, Human Clinical Trial
Official title:
Assessment of the Clinical Performance of the ARROW-FLU System for the Detection of Influenza A and B in Symptomatic Patients
The ARROW-FLU Influenza A&B Test is an in vitro diagnostic immuno-chromatographic assay intended for the qualitative detection of influenza A and influenza B viral nucleoprotein antigens from nasal or nasopharyngeal swab specimens in symptomatic patients. It is intended to aid in the rapid differential diagnosis of influenza A and/or B viral infections. This test is not intended for the detection of influenza C viruses. A negative test is presumptive and it is recommended these results be confirmed by cell culture of an FDA cleared molecular device. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions.
This multicenter prospective study will include nasal and nasopharyngeal swabs collected
from patients who present with flu-like symptoms and have undergone routine testing for
influenza virus strain types A or B. The ARROW-FLU Influenza A&B Test System qualitative
results will be compared to a reference method for identification of Influenza A or B to
determine the clinical sensitivity and specificity of the device.
The ARROW-FLU Influenza A&B Test system will be performed at CLIA-waived and non-CLIA waived
clinical sites. Device operators at CLIA-waived sites will be untrained intended users (e.g.
nurses, physician assistants, medical assistants, etc).
A subject's participation in this study will consist of a single visit. Following completion
of the informed consent process and a review of Inclusion/Exclusion criteria to determine
eligibility, each subject will receive a unique study identification number. After standard
of care sampling, two (2) nasal or nasopharyngeal swabs will be obtained from each subject
enrolled in the study. The swabs will be collected from the same nostril and alternated in
their order of designation for testing (i.e. one for ARROW-FLU Influenza System testing and
the other for reference testing. Any swab specimens required for standard of care testing
will be collected prior to the specimens for this investigation. Investigational device
operators will be blinded to standard of care testing results.
;
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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