A Multi-Site Clinical Evaluation of the ARIES Group A Strep Assay in Symptomatic Patients

Completed

• Conditions: Pharyngitis Bacterial
• Interventions: Device: ARIES Group A Strep Assay

• Registration Number: NCT03037957
• Lead Sponsor: Luminex Corporation

Brief Summary

A multi-center evaluation to assess the diagnostic sensitivity and specificity of the ARIES Group A Strep Assay will be established through a method comparison using prospectively collected, de-identified, clinical samples collected during the enrollment period.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-01-03
• Study Start: 2017-01-09
• Study First Submitted QC: 2017-01-27
• Study First Posted: 2017-01-31
• Primary Completion: 2017-06-02
• Study Completion: 2017-06-02
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-05
• Last Update Posted: 2017-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 704

Inclusion Criteria

• Patient and/or patient's legal guardian is willing and able to give informed consent and/or assent for extra research sample.
• The subject's specimen is a throat swab in Liquid Amies based transport medium.
• The specimen is from an adult or pediatric, male or female subject who is either hospitalized, admitted to a hospital emergency department, visiting an outpatient clinical or resident of a long term care facility.
• The specimen is from a patient for whom a requisition has been made for Group A Strep testing
• The specimen is from a patient exhibiting clinical signs and symptoms of pharyngitis consistent with Group A Strep infection.
• The specimen was received in good condition (no leakage or drying of the specimen).
• The specimen volume is ≥ 850 µL.

Exclusion Criteria

• The specimen is from a patient who did not provide informed consent/assent.
• The specimen is not a throat swab collected in Liquid Amies based transport medium.
• The specimen is from a patient who is undergoing antibiotic treatment.
• The specimen was not properly collected, transported, processed or stored according to the instructions provided by the Sponsor in Section 9 below.
• The specimen volume is < 850 µL.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group A Strep Assay	ARIES Group A Strep Assay	-

Primary Outcome Measures

Name	Time	Method
Clinical performance (sensitivity/specificity) for Group A Strep Assay	Day 1

Trial Locations

Locations (5)

Sacred Heart Hospital; 🇺🇸 Pensacola, Florida, United States

Advanced Pediatrics Research; 🇺🇸 Vienna, Virginia, United States

Children's Hospital Los Angeles; 🇺🇸 Los Angeles, California, United States

Children's Mercy Hospital; 🇺🇸 Kansas City, Missouri, United States

Marshfield Labs; 🇺🇸 Marshfield, Wisconsin, United States