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OpenTrials
Completed

NCT Number: NCT01309568

"Quidel Reader Influenza A + B Test 510(k) and CLIA Waiver Field Study"

The objective of this study is to demonstrate the clinical performance of the Quidel Reader Influenza A+B test and Quidel Reader with the following sample types: nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash. Clinical performance will be based on comparison of Quidel Reader Influenza A+B results to cell culture at a Central Reference or Alternative Laboratory.

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Key information

Conditions

Influenza Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

La Costa Pediatrics, Carlsbad, California, United States

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About this study

A sufficient number of subjects will be enrolled to achieve a required minimum of cell culture-positive specimens for each sample type, nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash.

  • The 510(k) study will include combined results from all sites and require the following for all three sample types: a minimum of 50 fresh positive results for influenza A, and 30 fresh positive results for influenza B.
  • The CLIA Waiver submission will include combined results from all sites for a total of 120 positive specimens for both influenza A and influenza B. The nasal swab will be the primary sample type planned for the CLIA Waiver submission. However, depending upon the prevalence of influenza, nasopharyngeal swab and/or nasopharyngeal aspirate/wash may also be submitted for CLIA Waiver.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or Female, of all ages (assuming appropriate consent is obtained).
  • Must currently be exhibiting symptoms characteristic of influenza-like-illness (ILI).

For example:

  • Fever, ≥ 38º C (100º F), either at the time of the visit or onset within the past two (2) days.
  • Nasal congestion
  • Rhinorrhea
  • Sore throat
  • Cough
  • Headache
  • Myalgia
  • Malaise

Exclusion criteria

  • Has undergone treatment with anti-influenza antivirals within the previous 7 days, including, for example, one or more of the following, but not be limited to Amantadine, Rimantadine, Ribavirin, Oseltamivir, Zanamivir or any other antiviral currently available in these classes.
  • Has been vaccinated by means of an influenza nasal spray/mist vaccine within the previous 7 days.
  • Unable to understand and consent to participation; for minors this includes parent or legal guardian.

Treatment and study plan

Primary outcomes

  1. Diagnosis of infection with influenza

    Time frame: 15 minutes

    Accurate diagnosis of infection with influenza A or influenza B confirmed by culture

Sponsors and collaborators

Lead sponsor

Quidel Corporation

Industry

Registry information

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Mar 7, 2011
Registry last updated
May 12, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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