A Study to Evaluate Near-Patient Tests for the Direct Detection of SARS-CoV-2
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Scottsdale/Phoenix, Arizona: 20-010688
About this study
The pupose of this study is to evaluate near-patient methods, including both point of care (POC) and patient-performed testing.
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. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- All adult (18 years or greater).
- Patients arriving to the drive-through testing area.
- Must be able to read, speak and understand English.
- Participant must have access to a smart phone with Android or iOS operating system.
- Patients may be symptomatic, asymptomatic/ pre-symptomatic, healthy, etc.
- Mayo Clinic employees will be allowed to participate as long as they are not a physician, advanced practitioner, nurse, medical assistant or laboratory personnel.
Exclusion Criteria:
- Individuals under 18 years of age.
- Patients with nasal packing (from ENT-related procedures).
- Any patient who declines.
- Any patient who has a visual impairment that prevents ability to do visual interpretation of test results.
- Works for a company that manufactures, sells, distributes, or utilizes medical and/or IVD tests, RDT readers or competitive companies.
- Employee or person who has been involved in the development of the HealthCheck Smartphone RDT Reader.
Eligibility last updated 11/19/21. Questions regarding updates should be directed to the study team contact.
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 |
|
Scottsdale/Phoenix, Ariz.
Mayo Clinic principal investigator Thomas Grys, Ph.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available