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

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).

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.