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

NCT01309568 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2500

Last updated 2011-05-12

No results posted yet for this study

Summary

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.

Conditions

Sponsors & Collaborators

  • Quidel Corporation

    lead INDUSTRY

Principal Investigators

  • John D Tamerius, PhD · Quidel Corporation

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2011-04-30
Completion
2011-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01309568 on ClinicalTrials.gov