Residual Sample Collection for Respiratory Viral Panel

Completed

• Conditions: Respiratory Viral Illnesses: Influenza A/B, RSV, Adenovirus

• Registration Number: NCT02049918
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2013-11
• Study First Submitted: 2014-01-23
• Study First Submitted QC: 2014-01-28
• Study First Posted: 2014-01-30
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-23
• Last Update Posted: 2015-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1487

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sample collection study only	prospective and retrospective sample collection	This is an IVD Diagnostic study.

Trial Locations

Locations (1)

Penn State Hershey Medical Center; 🇺🇸 Hershey, Pennsylvania, United States