This study is currently not recruiting participants.

Specimen Acquisition Protocol for DiagCORE? Respiratory Panel

Study of Respiratory Panel with Clinical Samples

Not Recruiting
100 years or below
All
Phase N/A

Brief description of study.

This protocol describes the process for acquiring samples that are either residual, de-identified specimens or previously characterized bacterial or viral clinical samples obtained from clinical specimens or retrospective samples that have been stored by the laboratory.

These specimens will be used to support internal development activities and/or analytical studies or clinical evaluations to support applicable filings required the U.S. (FDA) and/or ex-U.S./foreign government regulatory bodies to permit commercial distribution of the DiagCORE? Respiratory Panel.

Detailed description of study

This protocol describes the process for acquiring samples that are either residual, de-identified specimens or previously characterized bacterial or viral clinical samples obtained from clinical specimens or retrospective samples that have been stored by the laboratory.

These specimens will be used to support internal development activities and/or analytical studies or clinical evaluations to support applicable filings required the U.S. (FDA) and/or ex-U.S./foreign government regulatory bodies to permit commercial distribution of the DiagCORE? Respiratory Panel.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Healthy
  • Age: 100 years or below
  • Gender: All

This study investigates the use of clinical samples to develop and evaluate a respiratory panel. The respiratory panel is used to identify bacterial or viral infections from samples. Clinical samples are specimens obtained from patients, which can be used to study infections.

In this study, samples that have been stored or are not linked to patient identities will be used. These samples will help researchers understand how well the respiratory panel works in identifying infections.

  • Who can participate: This study uses stored or de-identified samples and does not involve new participants.
  • Study details: The study involves investigational methods to evaluate the respiratory panel using stored or de-identified samples.
Updated on 19 Feb 2024. Study ID: 1801722978

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