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

Overview

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.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: June 2, 2017

Interventions

  • Device: ARIES Group A Strep Assay

Arms, Groups and Cohorts

  • Group A Strep Assay

Clinical Trial Outcome Measures

Primary Measures

  • Clinical performance (sensitivity/specificity) for Group A Strep Assay
    • Time Frame: Day 1

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Luminex Corporation
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Ronald Dunn, Study Director, Luminex Corporation

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.