Residual Sample Collection for Respiratory Viral Panel

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.

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Key information

Conditions

Respiratory Viral Illnesses: Influenza A/B, RSV, Adenovirus Adenoviridae Infections DNA Virus Infections Infections Virus Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Sample collection study only

Time frame: prospective and retrospective sample collection

This is an IVD Diagnostic study.

Sponsors and collaborators

Lead sponsor

GenMark Diagnostics

Industry

Registry information

Official study title

De-identified Residual Sample Collection for the Respiratory Viral Panel on the GenMark Sample to Answer Platform (ARM 1)

Important dates

Study start: 2013
Primary completion: 2015
Study completion: 2015
First posted: Jan 30, 2014
Registry last updated: Dec 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed