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

Meso Scale Diagnostics

Status: Terminated

Conditions: Influenza Human

Treatments: Biological: Public Health Notification

Study type: Observational

Funder types: Industry; Other U.S. Federal agency

Identifiers

NCT00863343

MSD-ITPOC-01

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 391 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

391 participants in 1 patient group

All

Description:

Anyone presenting with influenza-like-illness

Treatment:

Biological: Public Health Notification