Clinical Evaluation of the Xpert® Expanded Respiratory Panel on the Genexpert® System Using Nasopharyngeal Swab Specimens
Thomas E. Davis
Primary Investigator
Brief description of study
What is the purpose of this study?
The purpose of the study is to develop a new diagnostic test for respiratory tract infections. This includes COVID-19. This new test may help in the detection and identification of DNA and RNA from multiple bacteria and/or viruses directly from nasopharyngeal swab specimens obtained from individuals with the signs and symptoms of respiratory tract infections, including COVID-19.
Detailed description of study
What will happen during the study?
Study participation will include providing a clinician collected nasopharyngeal swab for this study. This specimen should be collected after standard of care specimens are obtained, and from the opposite side of the standard of care specimen.
In addition, information about participant's health will be collected by the study staff in order to carry out the study.
The swab collected as part of this study will be sent to a laboratory identified by Cepheid. All participant information will be removed from the specimens before they are sent to the study sponsor and/or laboratory.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Respiratory tract infections, RTI
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Age: 100 years or below
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Gender: All
Inclusion criteria:
- Documentation that the study participant has provided informed consent required by
the reviewing institutional review board or ethics committee
- NPS specimen from participant who presents with signs and symptoms of RTI
