QuickVue Influenza A+B Clinical Field Trial

January 23, 2008 updated by: Quidel Corporation

Comparison of Swab Types for Specimen Collection

A comparative study of different swab types used for collection of specimens for rapid inluenza testing

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Mascot, New South Wales, Australia, 2020
        • Sydney Airport Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Subjects must have:

  • Fever (>38°C) (at time of visit or within the previous 48 hrs by history) and at least two of the following symptoms:

    • Chills/sweats
    • Cough
    • Dyspnea (labored, difficult breathing)
    • Fatigue
    • Headache
    • Myalgia (deep muscle aches)
    • Nasal congestion
    • Runny nose
    • Sore throat

Exclusion Criteria:

  • Patients who are undergoing treatment with antivirals, now or within the last 7 days cannot be included in this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sensitivity and Specificity
Time Frame: five months
five months

Secondary Outcome Measures

Outcome Measure
Time Frame
Sensitivity and Specificity
Time Frame: Positive and Negative Predictive Values
Positive and Negative Predictive Values

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Quidel Corporation

Investigators

  • Principal Investigator: Andrew Keller, MD, Sydney Airport Medical Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (Actual)

August 1, 2006

Study Completion (Actual)

August 1, 2006

Study Registration Dates

First Submitted

June 22, 2007

First Submitted That Met QC Criteria

June 25, 2007

First Posted (Estimate)

June 26, 2007

Study Record Updates

Last Update Posted (Estimate)

January 28, 2008

Last Update Submitted That Met QC Criteria

January 23, 2008

Last Verified

January 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CS-0119-08(B)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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