Sample Collection to Evaluate an Investigational Instrument for the Detection of Respiratory Viruses in Nasopharyngeal Swabs

GenMark Diagnostics

Status: Completed

Conditions: Viral Respiratory Infection

Study type: Observational

Funder types: Industry

Identifiers

NCT01806285

CTP0001

Details and patient eligibility

About

The purpose of this sample collection study is to prospectively collect respiratory viral clinical samples, conduct standard of care comparator testing and archive the collected residual samples for future testing in order to establish the clinical performance characteristics of the investigational instrument.

Enrollment: 205 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

205 participants in 1 patient group

Patients with Respiratory Symptoms