Residual Sample Collection for Respiratory Viral Panel

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. Identifier: NCT02049918
Recruitment Status : Completed
First Posted : January 30, 2014
Last Update Posted : December 28, 2015
Information provided by (Responsible Party):
GenMark Diagnostics

Brief Summary:
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 or disease
Respiratory Viral Illnesses: Influenza A/B, RSV, Adenovirus

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.

Study Type : Observational
Actual Enrollment : 1487 participants
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)
Study Start Date : November 2013
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Primary Outcome Measures :
  1. Sample collection study only [ Time Frame: prospective and retrospective sample collection ]
    This is an IVD Diagnostic study.

Biospecimen Retention:   Samples With DNA
Nasopharyngeal Swab

Information from the National Library of Medicine

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

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

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 identifier (NCT number): NCT02049918

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

Responsible Party: GenMark Diagnostics Identifier: NCT02049918     History of Changes
Other Study ID Numbers: CTP0006
First Posted: January 30, 2014    Key Record Dates
Last Update Posted: December 28, 2015
Last Verified: December 2015

Keywords provided by GenMark Diagnostics:
Respiratory viruses

Additional relevant MeSH terms:
Virus Diseases