Residual Sample Collection for Respiratory Viral Panel
Residual Sample Collection for Respiratory Viral Panel
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.
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.
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