Rapid Diagnostic Test for Influenza

April 17, 2015 updated by: Meso Scale Diagnostics, LLC.

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

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).

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

569

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Ha Noi, Vietnam
        • National Hospital of Pediatrics
      • Ho Chi Minh City, Vietnam
        • Hospital for Tropical Diseases
      • Ho Chi Minh City, Vietnam
        • Children's Hospital #2
      • Ho Chi Minh City, Vietnam
        • Children's Hospital 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Individuals visiting a health care facility.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
All
Anyone presenting with influenza-like-illness
For any H5 positive results, notification of the result to the site's local/regional public health authorities.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
4 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Jacqueline Perodin, PhD, CCRP, Meso Scale Diagnostics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

March 16, 2010

First Submitted That Met QC Criteria

March 18, 2010

First Posted (Estimate)

March 19, 2010

Study Record Updates

Last Update Posted (Estimate)

April 21, 2015

Last Update Submitted That Met QC Criteria

April 17, 2015

Last Verified

April 1, 2015

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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