Residual Sample Collection for Respiratory Viral Panel

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GenMark Diagnostics
ClinicalTrials.gov Identifier:
NCT02049918
First received: January 23, 2014
Last updated: December 23, 2015
Last verified: December 2015
  Purpose
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.

Condition
Respiratory Viral Illnesses: Influenza A/B, RSV, Adenovirus

Study Type: Observational
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)

Further study details as provided by GenMark Diagnostics:

Primary Outcome Measures:
  • Sample collection study only [ Time Frame: prospective and retrospective sample collection ] [ Designated as safety issue: No ]
    This is an IVD Diagnostic study.


Biospecimen Retention:   Samples With DNA
Nasopharyngeal Swab

Enrollment: 1487
Study Start Date: November 2013
Study Completion Date: November 2015
Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Children and adults of any age suspected of having respiratory infection.
Criteria

Inclusion Criteria:

  • Sample from patients exhibiting signs/symptoms of respiratory viral infection
  • All medical standard-of-care testing requested by the submitting clinician is complete and has been reported to the clinician/requestor.

Exclusion Criteria:

  • Samples that are incorrectly de-identified
  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: NCT02049918

Locations
United States, Pennsylvania
Penn State Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
GenMark Diagnostics
Investigators
Principal Investigator: Wallace Green, PhD Milton S. Hershey Medical Center
Principal Investigator: Michelle Fennell, MHA, MT(ASCP) Ingalls Memorial Hospital
  More Information

Responsible Party: GenMark Diagnostics
ClinicalTrials.gov Identifier: NCT02049918     History of Changes
Other Study ID Numbers: CTP0006 
Study First Received: January 23, 2014
Last Updated: December 23, 2015
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by GenMark Diagnostics:
Respiratory viruses

Additional relevant MeSH terms:
Adenoviridae Infections
Virus Diseases
DNA Virus Infections

ClinicalTrials.gov processed this record on July 26, 2016