Multi-Center Study of an In Vitro Diagnostic Device for the Detection of Strep A

IQuum, Inc.5 sites in 1 country799 target enrollmentDecember 2013

ConditionsStreptococcal Sore Throat

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Streptococcal Sore Throat
Sponsor: IQuum, Inc.
Enrollment: 799
Locations: 5
Primary Endpoint: Evaluate sensitivity and specificity of the Liat Strep A assay when compared to culture
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this trial is to show the accuracy and specificity of the Liat analyzer and assay for detecting Strep A at the point of care lab compared to culture.

Registry

clinicaltrials.gov

Start Date

December 2013

End Date

April 2014

Last Updated

9 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

IQuum, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects who are 3 years of age or older
•Subjects exhibiting symptoms characteristic of pharyngitis, possibly Streptococcus A, including:
•presence of sore throat, and at least one other symptom from the list below:
•redness of the posterior pharyngeal wall
•pharyngeal or tonsillar exudate
•tonsillar swelling
•tender cervical lymphadenopathy
•fever, \>38C at presentation or within the past 24 hours
•Subjects who are able to understand and consent to participation; for minors under the age of 18, this includes parent or legal guardian