Rapid Diagnostic Test for Influenza

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

569 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-03-31

Study Completion Date

2010-10-31

Brief Summary

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The primary objective of this study is to evaluate the performance of the MSD® Influenza Test in detecting influenza A and influenza B in subjects presenting with influenza-like-illness (ILI).

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Detailed Description

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This is a multicenter, prospective study to evaluate the performance of the MSD Influenza Test for the detection and differentiation of influenza A (including A/H1, A/H3, and A/H5 subtypes) and influenza B. Nasal swabs from subjects presenting at the clinical care facility with ILI will be collected and tested on the MSD Influenza Test. Results from the Test will be compared to results obtained from viral culture performed on a second nasal swab at a reference laboratory.

Conditions

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Influenza

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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All

Anyone presenting with influenza-like-illness

Local/Regional Public Health Notification

Intervention Type BIOLOGICAL

For any H5 positive results, notification of the result to the site's local/regional public health authorities.

Interventions

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Local/Regional Public Health Notification

For any H5 positive results, notification of the result to the site's local/regional public health authorities.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Any subject (all ages) presenting with ILI (defined as fever \[subjective or documented\] and cough or sore throat), and suspected of having influenza.
* Subject (parent, guardian, or authorized legal representative) gives informed consent to the study, and provides signed authorization for use and disclosure of protected health information.

Exclusion Criteria

* Subjects who had prior nasal wash/aspirate or nasopharyngeal wash/aspirate specimens collected for routine health-care purposes within the same suspected influenza infection episode.
* Unable to collect nasal and throat swab.
* Severely ill patient without a family relative to provide informed consent.

Eligible Sex

ALL

Accepts Healthy Volunteers

No