Residual Sample Collection for Respiratory Viral Panel
| Status: | Completed |
|---|---|
| Conditions: | Influenza, Infectious Disease, Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/21/2016 |
| Start Date: | November 2013 |
| End Date: | November 2015 |
De-identified Residual Sample Collection for the Respiratory Viral Panel on the GenMark Sample to Answer Platform (ARM 1)
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.
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.
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
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