Rapid Diagnostic Test for Influenza
This study has been completed.
Sponsor:
Meso Scale Diagnostics, LLC.
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
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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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01089816
Locations
| Vietnam | |
| 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 | |
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 RNA Virus Infections |
Virus Diseases Respiratory Tract Infections Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 23, 2013