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

Luminex

Status: Unknown

Conditions: Respiratory Tract Infection; Bronchitis; Pneumonia

Study type: Observational

Funder types: Industry

Identifiers

NCT02087761

LMA-FLU-01-CS-001

Details and patient eligibility

About

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.

Full 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).

Enrollment: 1,000 estimated patients

Sex: All

Volunteers: No 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.