"Quidel Reader Influenza A + B Test 510(k) and CLIA Waiver Field Study"
Public ClinicalTrials.gov record NCT01309568. 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.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The objective of this study is to demonstrate the clinical performance of the Quidel Reader Influenza A+B test and Quidel Reader with the following sample types: nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash. Clinical performance will be based on comparison of Quidel Reader Influenza A+B results to cell culture at a Central Reference or Alternative Laboratory.
Study identification
- NCT ID
- NCT01309568
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 2,500 participants
Conditions and interventions
Conditions
Interventions
Not listed
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
- Mar 31, 2011
- Completion
- Mar 31, 2011
- Last update posted
- May 11, 2011
2011
United States locations
- U.S. sites
- 16
- U.S. states
- 11
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| La Costa Pediatrics | Carlsbad | California | 92009 | — |
| Santo Nino Medical Clinic | Panorama City | California | 91402 | — |
| La Jolla Pediatrics | San Diego | California | 92121 | — |
| Complete Family Care | Northglenn | Colorado | 80234 | — |
| Adriana Castro, MD | Miami | Florida | 33173 | — |
| Teena Hughes, MD | Tampa | Florida | 33613 | — |
| DuPage Family Medicine | Naperville | Illinois | 60564 | — |
| Paul Janson, MD | Florence | Kentucky | 41042 | — |
| Paul McLaughlin, MD | Mount Sterling | Kentucky | 40353 | — |
| Kamakshi Neelkantan, MD | Edgewood | Maryland | 21040 | — |
| Priority Care Pediatrics | Kansas City | Missouri | 64155 | — |
| Robert Farron, DO | Far Rockaway | New York | 11691 | — |
| Twelve Corners Pediatrics | Rochester | New York | 14618 | — |
| Montrose Family Practice | Akron | Ohio | 44333 | — |
| Norristown Family Physicians | Norristown | Pennsylvania | 19401 | — |
| Dell's Children's Medical Center | Austin | Texas | 78723 | — |
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 NCT01309568, 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 11, 2011 · Synced Sep 26, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01309568 live on ClinicalTrials.gov.