Rapid Diagnostic Test for Influenza

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Meso Scale Diagnostics, LLC.
ClinicalTrials.gov Identifier:
NCT01089816
First received: March 16, 2010
Last updated: June 6, 2011
Last verified: June 2011
  Purpose

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).


Condition
Influenza

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Validation of the Point-of-Care MSD Influenza Test in Asia

Resource links provided by NLM:


Further study details as provided by Meso Scale Diagnostics, LLC.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Viral transport media containing nasal swab extract.


Estimated Enrollment: 1000
Study Start Date: March 2010
Study Completion Date: October 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
All
Anyone presenting with influenza-like-illness

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Individuals visiting a health care facility.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01089816

Locations
Vietnam
National Hospital of Pediatrics
Ha Noi, 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
Sponsors and Collaborators
Meso Scale Diagnostics, LLC.
Investigators
Study Director: Jacqueline Perodin, PhD, CCRP Meso Scale Diagnostics
  More Information

No publications provided

Responsible Party: Dennis Mertz/Director, Regulatory Affairs, Meso Scale Diagnostics
ClinicalTrials.gov Identifier: NCT01089816     History of Changes
Other Study ID Numbers: SEA034
Study First Received: March 16, 2010
Last Updated: June 6, 2011
Health Authority: Vietnam: Ministry of Health
United States: Food and Drug Administration

Keywords provided by Meso Scale Diagnostics, LLC.:
Influenza infections
Orthomyxoviridae infections
Influenza Human

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
Respiratory Tract Diseases
Respiratory Tract Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 30, 2014