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Completed

NCT Number: NCT00636662

FLU A+B Nasal Swab Clinical Study

The purpose of this clinical study is to obtain clearance for the nasal swab sample type by demonstrating the performance characteristics of the FLU A+B Test versus standard laboratory culture for Influenza A and B viruses using nasal swab samples.

Completed

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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

Mt. Sinai Hospital, Toronto, Ontario, Canada

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About this study

Patients exhibiting symptoms of influenza enrolled in a fashion that confidentiality of all personal health information is maintained.

No patient treatment is affected by enrollment in this trial.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male and Female of all age groups
  • Patients exhibiting influenza symptoms (i.e., fever, body aches, headaches, cough, sore throat, and other respiratory symptoms) at the time of examination
  • Patients must either present with a fever (>100ºF; >37.8ºC) at time of examination or have had a fever (>100ºF; >37.8ºC) or declare at time of the examination that they had a fever within the previous 3 days prior to the examination
  • Must be able to collect sample using the nasal swab sample type

Exclusion criteria

  • Patients with no fever at time of examination or within the 3 days prior to examination and/or are currently undergoing treatment (including anti-virals) will be excluded from the study.

Treatment and study plan

Non-invasive diagnostic testing

Other

No patient treatment is altered by enrollment in this trial

Primary outcomes

  1. Support the addition of nasal swab sample type to labeling for the FLU A+B Test. The nasal swab sample data will be analyzed for the FLU A+B Test versus standard laboratory culture identification to determine the sensitivity and specificity.

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

Response Biomedical Corp.

Industry

Registry information

Official study title

Evaluation of the RAMP FLU A+B Test Versus Viral Culture Using Clinical Nasal Swab Samples From Patients With Suspected Influenza Infections

Acronym: FLUA+B

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Mar 14, 2008
Registry last updated
Mar 27, 2019

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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