Clinical Trials

Inclusion Criteria:

• Patients being tested for influenza for clinical diagnosis.

Exclusion Criteria:

• Vulnerable patients or patients unable to provide informed consent.
• We have an already approved IRB protocol (IRB 17-000347) allowing for patient sample testing of our prototypes but that does not include patient enrollment. We project the enrollment of 75 patients undergoing influenza testing within 1 year here at Mayo Clinic, Rochester, MN.
• Based on our past and current patient population we expect that approximately 25% of the enrolled patients will test positive. This will give us approximately 19 patients screening positive for influenza strain and 56 patients testing negative. The sample will be collected by the patient (sputum in standard clinical vial) only identified by a Subject ID, time, and date. The test will be performed immediately following the collection of the sample by a research team away from the patient. Neither the patient nor the medical team will be informed about the test result. The positive or negative result will be recorded by the research team and the result from the clinical test will be retrieved and recorded when available. If the vial-based influenza results are statistically discordant from the clinical standard we will pursue the source of the error (sensitivity/specificity differences) and adjust the parameters in the fabrication to address those issues.