Residual Sample Collection for Respiratory Viral Panel

GenMark Diagnostics

Status: Completed

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

Study type: Observational

Funder types: Industry

Identifiers

NCT02049918

CTP0006

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,487 patients

Sex: All

Volunteers: No 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