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NCT01302418 · ClinicalTrials.gov registry record
Collection and Testing of Respiratory Samples
A clinical trial, sponsored by QIAGEN Gaithersburg.
- Completed
- Registry status
- 272
- Enrollment target
NCT01302418: Completed study, sponsored by QIAGEN Gaithersburg.
NCT01302418 is a clinical trial that has completed, run by QIAGEN Gaithersburg. The registered enrollment target is 272 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01302418 has completed, sponsored by QIAGEN Gaithersburg.
- COMPLETED
- Registry status
- 272 participants
- Enrollment target
Study Summary
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.
Primary Outcome
The presence of Influenza A or Influenza B virus.
Interventions
- DEVICE artus Influenza A/B RT-PCR Test
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 272 participants |
| Start Date | 2011-02 |
| Est. Completion | 2011-11 |
What the finished NCT01302418 record still lists
NCT01302418 is an observational study that tracks outcomes without assigning an intervention. The registered 272 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which artus Influenza A/B RT-PCR Test is the first listed.
NCT01302418 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01302418 about?
NCT01302418 is a clinical study titled "Collection and Testing of Respiratory Samples". 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 clinica...
What is the current status of trial NCT01302418?
This trial is currently completed. The enrollment target is 272 participants. The study started on 2011-02. Estimated completion is 2011-11.
What interventions are being tested in trial NCT01302418?
The interventions under investigation include: artus Influenza A/B RT-PCR Test (DEVICE).
Who is sponsoring clinical trial NCT01302418?
This trial is sponsored by QIAGEN Gaithersburg, which has 11 total clinical trials registered on ClinicalTrials.gov.
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