"Quidel Reader Influenza A + B Test 510(k) and CLIA Waiver Field Study"

ClinicalTrials.gov ID: NCT01309568

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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
Lead sponsor: Quidel Corporation; Industry
Enrollment: 2,500 participants

Conditions and interventions

Conditions

Influenza

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: Feb 2011 (Type not available)
Primary completion: Apr 2011 (Actual)
Completion: Apr 2011 (Actual)
Last update posted: May 12, 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 12, 2011 · Synced Nov 13, 2026