Rapid Diagnostic Test for Influenza

Meso Scale Diagnostics, LLC.569 enrolled

Overview

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).

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 Type

OBSERVATIONAL

Enrollment

569

Conditions

Influenza

Interventions

Local/Regional Public Health NotificationBIOLOGICAL

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

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (4)

National Hospital of Pediatrics

Hà Nội, Vietnam

Children's Hospital #2

Ho Chi Minh City, Vietnam

Children's Hospital 1

Ho Chi Minh City, Vietnam

Hospital for Tropical Diseases

Ho Chi Minh City, Vietnam

Outcomes

Primary Outcomes

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

Time frame: 4 months

Secondary Outcomes

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.

Time frame: 4 months

Data from ClinicalTrials.gov

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