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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

704 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-09

Study Completion Date

2017-06-02

Brief Summary

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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.

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Detailed Description

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Conditions

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Pharyngitis Bacterial

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Group A Strep Assay

ARIES Group A Strep Assay

Intervention Type DEVICE

Interventions

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ARIES Group A Strep Assay

Intervention Type DEVICE

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No