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Clinical Performance Study of the Ultra Influenza A&B Test Using Nasal Swabs for Identifying Subjects Who Are Infected With the Influenza Virus Strain Type A or Type B

NCT01753531 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 677

Last updated 2013-06-24

No results posted yet for this study

Summary

The clinical performance of the Ultra Influenza A\&B Test will be demonstrated during a clinical trial in which prospectively collected nasal swabs are used in identifying subjects who are infected with the influenza virus strain type A or type B. The Ultra Influenza A\&B Test qualitative results will be compared to "Gold Standard" viral culture with Direct Fluorescent Antibody (DFA) confirmation techniques using nasal swabs collected from symptomatic subjects. The Ultra Influenza A\&B Test will be performed at Clinical Laboratory Improvement Amendments (CLIA) waived sites by untrained intended users (e.g. nurses, physician assistants, medical assistants, etc.). For viral culture testing with DFA confirmation testing, nasal swab specimen testing will be performed by a designated reference laboratory.

Conditions

  • Influenza, Human

Interventions

DEVICE

Flu Symptoms

Sponsors & Collaborators

  • Sekisui Diagnostics, LLC

    lead INDUSTRY

Principal Investigators

  • Robert D Rosen, MD · Ardmore Family Practice

Eligibility

Min Age
3 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2013-04-30
Completion
2013-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01753531 on ClinicalTrials.gov