Residual Sample Collection for Respiratory Viral Panel

Overview

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.

Full Title of Study: “De-identified Residual Sample Collection for the Respiratory Viral Panel on the GenMark Sample to Answer Platform (ARM 1)”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Cross-Sectional
  • Study Primary Completion Date: November 2015

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.

Clinical Trial Outcome Measures

Primary Measures

  • Sample collection study only
    • Time Frame: prospective and retrospective sample collection
    • This is an IVD Diagnostic study.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • GenMark Diagnostics
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Wallace Green, PhD, Principal Investigator, Milton S. Hershey Medical Center
    • Michelle Fennell, MHA, MT(ASCP), Principal Investigator, Ingalls Memorial Hospital

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