A Study to Evaluate a Real-Time Diagnostic Platform for the Detection of Influenza Strains in Saliva

Overview

About this study

The purpose of this study is to develop a colorimetric test for influenza virus detection in a chemically engineered cup/tube. When sample fluid (saliva) is in the tube, the fluid color turning blue indicates a positive result. We are in the process of developing this test, and will test on saliva samples from flu patients.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Please contact the study team to discuss whether or not you are eligible to participate in a study.

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.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Marina Walther-Antonio, Ph.D.

Open for enrollment

Contact information:

Derek Vanmeter

(507)255-4732

Vanmeter.Derek@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20471345

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