xTAG RPP assay is a PCR-based assay to detect the presence or absence of viral and bacterial DNA / RNA in clinical specimens (nasopharyngeal swabs).

The objective of this study is to establish diagnostic accuracy of the xTAG RPP.

Inclusion Criteria:

• The specimen is a nasopharyngeal swab.
• The specimen is from a pediatric or adult, male or female subject who is either hospitalized, admitted to a hospital emergency department, visiting an outpatient clinic or resident of a long-term care facility.
• The specimen is from a patient exhibiting clinical signs and symptoms of respiratory tract infection such as fever, sore throat, shortness of breath, bronchitis, bronchiolitis and pneumonia.

Exclusion Criteria:

• The specimen is not a nasopharyngeal swab.
• The specimen is from an individual who does not exhibit clinical signs and symptoms of respiratory tract infection.

Clinical specimens collected from patients with clinical signs and symptoms of respiratory tract infection who are either hospitalized, admitted to emergency departments or visiting outpatient clinics.