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

Pharyngitis Bacterial Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03037957
• Other study ID #: LMA-GAS-01-CS-006
• Status: Completed
• Phase: N/A
• First received: January 3, 2017
• Last updated: July 5, 2017
• Start date: January 9, 2017
• Est. completion date: June 2, 2017

Study information

• Verified date: July 2017
• Source: Luminex Molecular Diagnostics
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 704
• Est. completion date: June 2, 2017
• Est. primary completion date: June 2, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Pharyngitis
• Pharyngitis Bacterial

Intervention

Device:
• ARIES Group A Strep Assay

Locations

Country	Name	City	State
United States	Children's Mercy Hospital	Kansas City	Missouri
United States	Children's Hospital Los Angeles	Los Angeles	California
United States	Marshfield Labs	Marshfield	Wisconsin
United States	Sacred Heart Hospital	Pensacola	Florida
United States	Advanced Pediatrics Research	Vienna	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Luminex Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical performance (sensitivity/specificity) for Group A Strep Assay		Day 1