Residual Sample Collection for Respiratory Viral Panel

December 23, 2015 updated by: GenMark Diagnostics

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

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.

Study Overview

Status

Completed

Conditions

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

Enrollment (Actual)

1487

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Penn State Hershey Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Children and adults of any age suspected of having respiratory infection.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GenMark Diagnostics

Investigators

  • Principal Investigator: Wallace Green, PhD, Milton S. Hershey Medical Center
  • Principal Investigator: Michelle Fennell, MHA, MT(ASCP), Ingalls Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

January 23, 2014

First Submitted That Met QC Criteria

January 28, 2014

First Posted (Estimate)

January 30, 2014

Study Record Updates

Last Update Posted (Estimate)

December 28, 2015

Last Update Submitted That Met QC Criteria

December 23, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTP0006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Respiratory Viral Illnesses: Influenza A/B, RSV, Adenovirus

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Thailand

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe