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Rapid Diagnostic Test for Influenza

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01089816
First Posted: March 19, 2010
Last Update Posted: April 21, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Meso Scale Diagnostics, LLC.
  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 Intervention
Influenza Biological: Local/Regional Public Health Notification

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 ]

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 ]

Biospecimen Retention:   Samples With DNA
Viral transport media containing nasal swab extract.

Enrollment: 569
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 Assigned Interventions
All
Anyone presenting with influenza-like-illness
Biological: Local/Regional Public Health Notification
For any H5 positive results, notification of the result to the site's local/regional public health authorities.

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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.
Centers for Disease Control and Prevention
Investigators
Study Director: Jacqueline Perodin, PhD, CCRP Meso Scale Diagnostics
  More Information

Responsible Party: Meso Scale Diagnostics, LLC.
ClinicalTrials.gov Identifier: NCT01089816     History of Changes
Other Study ID Numbers: SEA034
First Submitted: March 16, 2010
First Posted: March 19, 2010
Last Update Posted: April 21, 2015
Last Verified: April 2015

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

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