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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01806285

Enrollment

205

Registered

2013-03-07

Start date

2013-02-28

Completion date

2015-11-30

Last updated

2015-12-28

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

Conditions

Viral Respiratory Infection

Keywords

Respiratory Virus

Brief summary

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

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.

Design outcomes

Primary

Measure	Time frame
Sample collection study only	prospective sample collection

Outcome results