Residual Sample Collection for Respiratory Viral Panel

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02049918

Enrollment

1487

Registered

2014-01-30

Start date

2013-11-30

Completion date

2015-11-30

Last updated

2015-12-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Respiratory viruses

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

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

Countries

United States

Outcome results