Nasal Swab Home Collection Kit (NSHC Kit) Study
Completed
Conditions studied: Influenza Viral Infections
In brief
The purpose of this study is to demonstrate that persons over the age of 13 years can obtain a self-collected nasal swab reliably and safely for subsequent use in the diagnosis of influenza. Similarly, the purpose is to demonstrate that parents or guardians can safely and effectively collect nasal swab specimens from children, ages 0 through 12 years, and others needing assistance in doing so, and that these parent/guardian-collected nasal swabs can also be used in the diagnosis of influenza. Clinical performance of the swabs will be based on the comparison of the performance of the nasal swab that is self- or parent/guardian-collected to one collected from the same specimen donor by a skilled clinical coordinator and used in CLIA (Clinical Laboratory Improvement Amendments)-waived, rapid diagnostic test called Sofia Influenza A+B FIA (fluorescence immunoassay analyzer).
Key facts
- Study ID
- NCT03813966
- Run by
- University of Wisconsin, Madison
- People needed
- 1181
- Starts
- 2019-02-07
- Expected to finish
- 2020-06-30
- Last updated by the study team
- 2020-10-05
Who can join
Age: any. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Fever
- Nasal Congestion
- Rhinorrhea
- Sore Throat
- Cough
You may not qualify if…
- Unable to read and understand or refusal to sign the appropriate informed consent/assent forms
- Refusal to complete the patient's demographic and medical history
- Treatment with anti-influenza antivirals within the previous 7 days
- Vaccinated by means of an influenza nasal spray/mist vaccine within the previous 7 days.
Where it is running
- UWHealth Urgent Care Clinics — Madison, Wisconsin, United States
- UW Health Urgent Care Clinics — Madison, Wisconsin, United States
Full record on ClinicalTrials.gov
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