Clinical Validation of the Point-of-Care MSD Influenza Test

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

391 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-03-31

Study Completion Date

2010-08-31

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 Human

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

Public Health Notification

Intervention Type BIOLOGICAL

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

Interventions

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Public Health Notification

For any H5 positive results, notification of the result to the site's local 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 or assent (child) to the study, and provides signed authorization for use and disclosure of protected health information.

Exclusion Criteria

* Any subject classified as "high risk" for exposure to avian or novel influenza, as determined by a Risk-Assessment Questionnaire.
* 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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No