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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02087761

Enrollment

1000

Registered

2014-03-14

Start date

2015-12-31

Completion date

Unknown

Last updated

2016-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchitis, Pneumonia, Respiratory Tract Infection

Keywords

ARIES Flu

Brief summary

The ARIES Flu Assay is a real-time PCR based qualitative assay for the direct detection and differentiation of respiratory viral nucleic acid in nasopharyngeal swabs specimens. The objective of this study is to establish the diagnostic accuracy of ARIES Flu Assay.

Detailed description

The ARIES Flu Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and differentiation of respiratory viral nucleic acid in nasopharyngeal swabs specimens from patients with signs and symptoms of respiratory tract infection in conjunction with clinical and laboratory findings. The objective is to establish the diagnostic accuracy of ARIES Flu Assay through a multi-site, method comparison on prospectively collected, left-over, and de-identified, nasopharyngeal swab specimens. Diagnostic accuracy will be expressed in terms of clinical sensitivity (or positive agreement) and specificity (or negative agreement).

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* The specimen is from a patient suspected of having respiratory tract infection for whom a requisition has been made for viral testing * The specimen is from a male of female subject who was either hospitalized, admitted to a hospital emergency department or visiting an outpatient clinic. * The specimen is a nasopharyngeal swab

Exclusion criteria

* The specimen is NOT a nasopharyngeal swab * The specimen was not properly collected, transported or stored according to the instructions provided by the sponsor.

Design outcomes

Primary

Measure	Time frame	Description
Diagnostic accuracy will be expressed in terms of clinical sensitivity (or positive agreement) and specificity (or negative agreement).	Within the first year of sample collection	Accuracy determinations (diagnostic sensitivity and specificity, positive and negative agreement) were based on the fraction of comparator positive (or negative) results which were also positive (or negative) by ARIES Flu assay.

Countries

United States

Outcome results