Rapid Diagnostic Test for Influenza

Completed

• Conditions: Influenza
• Interventions: Biological: Local/Regional Public Health Notification

• Registration Number: NCT01089816
• Lead Sponsor: Meso Scale Diagnostics, LLC.

Brief Summary

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).

Detailed 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.

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-03-16
• Study First Submitted QC: 2010-03-18
• Study First Posted: 2010-03-19
• Primary Completion: 2010-08
• Study Completion: 2010-10
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-17
• Last Update Posted: 2015-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 569

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All	Local/Regional Public Health Notification	Anyone presenting with influenza-like-illness

Primary Outcome Measures

Name	Time	Method
To determine the sensitivity and specificity of influenza A and B, and subtypes A/H1 and A/H3 with nasal and throat specimens for the MSD Influenza test as compared to cell culture and sequencing in a cross-section of the general population	4 months

Secondary Outcome Measures

Name	Time	Method
To determine the specificity of influenza subtype A/H5 in nasal and throat specimens for the MSD Influenza test as compared to cell culture and sequencing in a cross section of the general population.	4 months

Trial Locations

Locations (4)

National Hospital of Pediatrics; 🇻🇳 Ha Noi, Vietnam

Children's Hospital 1; 🇻🇳 Ho Chi Minh City, Vietnam

Children's Hospital #2; 🇻🇳 Ho Chi Minh City, Vietnam

Hospital for Tropical Diseases; 🇻🇳 Ho Chi Minh City, Vietnam