NCT02049918

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
• Phase: —
• Study type: Observational
• Enrollment: 1,487 (actual)
• Sponsor: GenMark Diagnostics · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

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

Timeline

• Start date: 2013-11-01
• Primary completion: 2015-11-01
• Completion: 2015-11-01
• First posted: 2014-01-30
• Last updated: 2015-12-28

Locations

1 site across 1 country: United States