Residual Sample Collection for Respiratory Viral Panel

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1487 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-11-30

Study Completion Date

2015-11-30

Brief Summary

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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

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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.

Conditions

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

Keywords

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Respiratory viruses

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wallace Green, PhD

Role: PRINCIPAL_INVESTIGATOR

Milton S. Hershey Medical Center

Michelle Fennell, MHA, MT(ASCP)

Role: PRINCIPAL_INVESTIGATOR

Ingalls Memorial Hospital

Locations

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Penn State Hershey Medical Center

Hershey, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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CTP0006

Identifier Type: -

Identifier Source: org_study_id