Residual Sample Collection for Respiratory Viral Panel
|ClinicalTrials.gov Identifier: NCT02049918|
Recruitment Status : Completed
First Posted : January 30, 2014
Last Update Posted : December 28, 2015
|Condition or disease|
|Respiratory Viral Illnesses: Influenza A/B, RSV, Adenovirus|
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.
|Study Type :||Observational|
|Actual Enrollment :||1487 participants|
|Observational Model:||Case Control|
|Official Title:||De-identified Residual Sample Collection for the Respiratory Viral Panel on the GenMark Sample to Answer Platform (ARM 1)|
|Study Start Date :||November 2013|
|Actual Primary Completion Date :||November 2015|
|Actual Study Completion Date :||November 2015|
- Sample collection study only [ Time Frame: prospective and retrospective sample collection ]This is an IVD Diagnostic study.
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02049918
|United States, Pennsylvania|
|Penn State Hershey Medical Center|
|Hershey, Pennsylvania, United States, 17033|
|Principal Investigator:||Wallace Green, PhD||Milton S. Hershey Medical Center|
|Principal Investigator:||Michelle Fennell, MHA, MT(ASCP)||Ingalls Memorial Hospital|