Flu Study - A Multi-Center, Prospective Clinical Trial to Evaluate the Clinical Performance of the GenMark® Sample to Answer Platform System for the Detection of Respiratory Viruses in Nasopharyngeal Swab Samples (IRB# 41963)
- Principal Investigator: Ian M. Paul, M.D., M.Sc.
We are evaluating respiratory viral nasal swab samples for use on a new diagnostic instrument and test for the detection of respiratory viral infections. This research is being done to find out the sensitivity and specificity of our new instrument as compared to standard culture testing; in other words, how well our product detects and correctly identifies various respiratory viruses in patient samples.
-Exhibiting one or more symptoms/signs suggestive of viral respiratory infection (e.g., fever, body aches, headaches, cough, sore throat, fatigue, runny/stuffy nose, or other respiratory symptoms) at the time of examination;
-At time of examination, either presenting with a fever or declares that he/she had a fever within the previous 5 days
-Onset of symptoms within 5 days of study enrollment;
-Willing and able to provide written informed consent/HIPAA.
Additional Study Details:
Participants will be approached during an acute clinic visit (exam room). Subjects will be enrolled and stratified into the following age groups: 0-5, 6-21, 22-59 and >60 years of age if they meet eligibility requirements and are able to provide the specimens. 1 to 2 nasopharyngeal swabs will be obtained and tested.
Pediatrics at 35 Hope Drive
Pediatric Clinical Research Office