Residual Sample Collection for Respiratory Viral Panel
Collect de-identified, residual samples to support a clinical trial. Samples may be prospectively or retrospectively collected. Overall Study Objective Obtain clinical performance data to characterize clinical performance of the Respiratory Viral Panel on the GenMark Sample-to-Answer Platform.
Respiratory Viral Illnesses: Influenza A/B, RSV, Adenovirus
|Study Design:||Observational Model: Case Control
Time Perspective: Cross-Sectional
|Official Title:||De-identified Residual Sample Collection for the Respiratory Viral Panel on the GenMark Sample to Answer Platform (ARM 1)|
- Percentage of patient specimens that test positive by new test method vs. those that test positive by the gold standard method e.g., Culture [ Time Frame: One year from collection and culture testing to testing by new test method. ] [ Designated as safety issue: No ]This is an IVD Diagnostic study.
Biospecimen Retention: Samples With DNA
|Study Start Date:||November 2013|
|Estimated Study Completion Date:||November 2014|
|Estimated Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
The purpose of this investigational study is to collect clinical samples to establish the clinical performance characteristics of the in vitro diagnostic (IVD) Respiratory Viral Panel on the GenMark Sample-to-Answer Platform. Data obtained from the samples will be used to support premarket submissions/registrations for this GenMark product. Samples will be aliquotted, characterized by comparator methods and banked until the instrument and assay are available for testing.
Sample collection may be prospective or retrospective. Prospective collection will preserve prevalence. Retrospective collection will be used to obtain sufficient numbers of certain sample types such as where the organism of interest is of low prevalence. The Sponsor will ensure that information identifying samples as prospectively or retrospectively collected is documented.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02049918
|Contact: Jacqueline M Weir||(760) firstname.lastname@example.org|
|Contact: Loralie R Yzerman, RN BScN||(760) email@example.com|
|United States, Pennsylvania|
|Penn State Hershey Medical Center||Recruiting|
|Hershey, Pennsylvania, United States, 17033|
|Contact: Wallace Greene, PhD|
|Contact: Julie Vallati, LPN :717-531-7047|
|Principal Investigator: Wallace Greene, Phd|
|Principal Investigator:||Wallace Green, PhD||Milton S. Hershey Medical Center|
|Principal Investigator:||Tony Mazzulli, MD, FRCPC, FACP||Mount Sinai Hospital, Canada|
|Principal Investigator:||Michelle Fennell, MHA, MT(ASCP)||Ingalls Memorial Hospital|