Nasal Swab Home Collection Kit (NSHC Kit) Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1181 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-02-07

Study Completion Date

2020-06-30

Brief Summary

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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).

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Detailed Description

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Conditions

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Influenza Viral Infections

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Sofia Influenza A+B FIA

The Nasal Swab Home Collection Kit (NSHC Kit) provides the materials and training needed for you to safely collect a nasal swab at home. The sample can then be delivered to a designated test site for influenza testing.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Fever
* Nasal Congestion
* Rhinorrhea
* Sore Throat
* Cough

Exclusion Criteria

* 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.

Minimum Eligible Age

0 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes