None listed
Conditions
Brief summary
Approximately 750 subjects, presenting with flu-like symptoms, will be prospectively enrolled and samples (nasal swab samples) will be collected from consecutive patients. All subjects will be assigned a unique subject identification (ID) number in sequential order as they are enrolled into the study. Each site will collect two nasal swabs from each subject. Clearview testing of patient samples will be conducted by more than one operator, and the testing will be equally distributed among the operators at each site. The 3 New Zealand (NZ) sites will be classified as “untrained user” sites and will receive no formal training on the performance and interpretation of the investigational device. No additional written procedures beyond the information contained within the protocol and the written test procedure will be provided. The test operators at the “untrained user” sites will be provided with an operator questionnaire at the conclusion of enrollment at that site. All specimens will be tested with the Clearview (registered trademark) Influenza A+B Test according to product instructions, and will be sent to a clinical laboratory for viral culture
Interventions
Subjects presenting with Influenza type symptoms will have nasal swabs tested with the investigational test - Clearview A+B Influenza Test.
The Clearview Influenza A+B Test is an in vitro diagnostic immunochromatographic membrane assay that uses monoclonal antibodies to detect influenza type A and B nucleoprotein antigens in respiratory specimens. These antibodies and a control protein are immobilized onto a membrane support as three distinct lines and are combined with other reagents/pads to
Subjects presenting with Influenza type symptoms will have nasal swabs tested with the investigational test - Clearview A+B Influenza Test. The Clearview Influenza A+B Test is an in vitro diagnostic immunochromatographic membrane assay that uses monoclonal antibodies to detect influenza type A and B nucleoprotein antigens in respiratory specimens. These antibodies and a control protein are immobilized onto a membrane support as three distinct lines and are combined with other reagents/pads to construct a test strip. Samples are added to a reaction tube to which an extraction reagent has been added. A Clearview test strip is then placed in the reaction tube holding the liquid sample. Test results are interpreted at 10 minutes based on the presence or absence of pink-to-purple colored Sample Lines. A blue Control Line indicates a valid test.
Sponsors
Inverness Medical (IMI)
Study design
Allocation
Non-randomised trial
Primary purpose
Diagnosis
Eligibility
Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
No
Inclusion criteria
presented to clinic with 2 of the following symptoms: fever, headache, extreme tiredness, dry cough, sore throat, runny or stuffy nose, muscle aches AND/OR participant is suspected of having influenza.
Exclusion criteria
Received a nasal vaccine within the last 5 days, or currently taking an antiviral medication for influenza within the past 30 days.
Outcome results
None listed