N/A
N=272
Collection and Testing of Respiratory Samples
QIAGEN ResPlex II Advanced Panel · Influenza A · Respiratory Syncytial Virus Infections · Infection Due to Human Parainfluenza Virus 1 · Parainfluenza Type 2
Bottom Line
View on ClinicalTrials.gov: NCT01302418 ↗Enrolled (actual)
272
Serious AEs
0.0%
Results posted
Jun 2012
Primary outcome: Primary: Detection of Respiratory Viruses — 83 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- artus Influenza A/B RT-PCR Test (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- QIAGEN Gaithersburg, Inc
- Primary completion
- Jul 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Detection of Respiratory Viruses |
83 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- Subjects where the duration of the symptoms of such an acute respiratory infection is greater than or equal to 5 days (i.e., ≥5).
Data sourced from ClinicalTrials.gov (NCT01302418). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.