Strep Throat Testing Device Study

Pilot Study of Strepic® Device for the Diagnosis of Group A Streptococcal (GAS) Pharyngitis

Protocol Description

The purpose of this study is to evaluate a new rapid test using the Strepic® device for identifying strep throat, a condition caused by streptococcus bacteria. The Strepic device shines a special light into the throat and takes a picture that can be computer analyzed to determine whether strep is present. Strepic device results will be compared against findings from traditional tests to help refine the computer algorithm for diagnosis. the results of which can take hours or days. Researchers believe that a device providing a faster method of testing for strep throat than traditional methods, which can take hours or days, could improve patient care by avoiding the need for a throat swab and problems of unnecessary antibiotics or untreated strep throat.

Eligibility Criteria

Patients who present in the Emergency Room of UPMC Children’s Hospital of Pittsburgh with a sore throat, for which testing will be done, are eligible to participate.
Males and Females: Ages 7 through 17 years

Requirements

A traditional throat culture or a PCR test (polymerase chain reaction test) will be done along with imaging using the Strepic device. Additionally, study staff will collect information about symptoms experienced by participants. Results of the traditional lab tests will be provided to patients’ personal physicians for treatment and follow up.
Visits: 1
Duration: Not applicable

Status: Open for Enrollment

Source(s) of Support

YES Biotechnology, Inc.

Primary Investigator

Robert W. Hickey, MD

Contact Information

For more information about the study or enrollment, please contact:
Research Coordinator
412-864-8380