Collection and Extraction of Respiratory Specimens
Completed
Conditions studied: Influenza
In brief
The study will be conducted with nasopharyngeal swab specimens collected prospectively from individuals suspected of having an acute respiratory tract infection caused by an Influenza virus. A series of standard viral culture tests validated for routine use in the clinical laboratory, as well as the CDC swine H1N1 test will be used to establish a collection of well characterized specimens. For each specimen four (4) aliquots will be prepared. One aliquot will be tested in real-time using the requisite viral culture reference methods, one aliquot will be used for H1N1 reference testing, one aliquot will be used to extract nucleic acid in real-time, and one aliquot of the UTM will be archived for the purpose of sequencing to confirm Influenza-positive specimens. The extracted nucleic acid and any remaining specimen will be stored at -70°C for later testing by the artus Influenza RG PCR test, or other investigational method(s).
Key facts
- Study ID
- NCT01083511
- Run by
- QIAGEN Gaithersburg, Inc
- People needed
- 600
- Starts
- 2010-03-01
- Expected to finish
- 2010-06-01
- Last updated by the study team
- 2014-05-14
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Subjects that sign the Informed Consent form required for prospectively enrolling patients into the study.
- Subjects that present at a hospital, clinic, or physician's office with symptoms of a respiratory tract infection.
- Subjects with an acute respiratory infection where said acute respiratory infection is suspected of being caused by an Influenza virus.
You may not qualify if…
- Subjects where the duration of the symptoms of such an acute respiratory infection is greater than or equal to 7 days (i.e., ≥7).
Where it is running
- University of Arizona — Tucson, Arizona, United States
- The University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
- Ohio State University — Columbus, Ohio, United States
Full record on ClinicalTrials.gov
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