Collection and Testing of Respiratory Samples
Public ClinicalTrials.gov record NCT01302418. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Testing of Respiratory Specimens for the Validation of the QIAGEN ResPlex II Advanced Panel Test and the Artus Influenza A/B RT-PCR Test
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01302418
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 272 participants
Conditions and interventions
Conditions
- 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
Eligibility (public fields only)
- Age range
- Not listed
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 31, 2011
- Primary completion
- Jun 30, 2011
- Completion
- Oct 31, 2011
- Last update posted
- May 9, 2017
2011
United States locations
- U.S. sites
- 5
- U.S. states
- 4
- U.S. cities
- 4
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Arizona | Tuscon | Arizona | 85719 | — |
| Albany Medical College | Albany | New York | 12208 | — |
| Wadsworth Center, New York State Department of Health | Albany | New York | 12208 | — |
| The University of North Carolina | Chapel Hill | North Carolina | 27599 | — |
| Ohio State University | Columbus | Ohio | 43210 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01302418, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 9, 2017 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01302418 live on ClinicalTrials.gov.