Collection and Testing of Respiratory Samples

Completed

Conditions studied: QIAGEN ResPlex II Advanced Panel, Influenza A, Respiratory Syncytial Virus Infections, Infection Due to Human Parainfluenza Virus 1, Parainfluenza Type 2, Parainfluenza Type 3, Parainfluenza Type 4, Human Metapneumovirus A/B, Rhinovirus, Coxsackie Virus/Echovirus, Adenovirus Types B/C/E, Coronavirus Subtypes 229E, Coronavirus Subtype NL63, Coronavirus Subtype OC43, Coronavirus Subtype HKU1, Human Bocavirus, Artus Influenza A/B RT-PCR Test, Influenza B

In brief

The study will be conducted using nasopharyngeal swab specimens collected prospectively from individuals suspected of having the signs and symptoms of an acute respiratory tract infection caused by a respiratory virus. A series of standard viral culture tests validated for routine use in the clinical laboratory, and/or a series of PCR-based Laboratory Developed Tests (PCR-LDT) validated by a central reference laboratory will be used to verify the performance of the investigational artus Influenza A/B RT-PCR test and the QIAGEN ResPlex II Advanced Panel test. From each specimen five (5) aliquots will be prepared: (a) one aliquot will be tested in real-time using the assigned viral culture reference methods; (b) one aliquot will be used to extract nucleic acid in real-time for investigational testing; (c) one aliquot of the specimen will be stored at --70C for subsequent shipment to the reference laboratory for PCR-LDT testing, (d) one aliquot will be archived at -70C for subsequent follow-up by the reference laboratory (e.g., bi-directional sequencing of positive specimens), and (e) any remaining specimen will be stored for the Fresh vs. Frozen Study. The extracted nucleic acid generated from the second aliquot (i.e., "b" above) will be split and subjected to testing by both the artus Influenza A/B RT-PCR test and the ResPlex II Advanced Panel test.

Key facts

Study ID

NCT01302418

Run by

QIAGEN Gaithersburg, Inc

People needed

272

Starts

2011-02-01

Expected to finish

2011-11-01

Last updated by the study team

2017-05-10

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 the signs and 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 5 days (i.e., ≥5).

Where it is running

• University of Arizona — Tuscon, Arizona, United States
• Albany Medical College — Albany, New York, United States
• Wadsworth Center, New York State Department of Health — Albany, New York, United States
• The University of North Carolina — Chapel Hill, North Carolina, United States
• Ohio State University — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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