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Purpose

The purpose of this study is to determine the reliability of a low-cost rapid diagnostic test for COVID-19. The method of the testing procedure uses electrochemistry to detect COVID-19 spike proteins within human samples. To test the effectiveness of this new method, patients will be recruited as they present for testing at ambulatory Penn testing sites. Patients will be asked to self-collect one anterior nares samples under the supervision of authorized study personnel.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  1. The subject must be an adult (age>17) and either sex. 2. Written informed consent must be obtained prior to study enrollment. a. A subject who is eighteen (18) years or older must be willing to give written informed consent and must agree to comply with study procedures. 3. Subject must be able to read and write in English.

Exclusion Criteria

  1. The subject is currently receiving or has received within the past thirty (30) days of the study visit an experimental biologic, drug, or device including either treatment or therapy. 2. The subject has previously participated in this research study.

Study Design

Phase
Study Type
Observational
Observational Model
Case-Only
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Positive Subjects that tested positive for COVID-19 based on the clinical gold standard PCR test.
  • Diagnostic Test: COVID Detect
    The study is determining the efficacy of a new rapid COVID testing method.
Negative Subjects that tested negative for COVID-19 based on the clinical gold standard PCR test.
  • Diagnostic Test: COVID Detect
    The study is determining the efficacy of a new rapid COVID testing method.

Recruiting Locations

More Details

NCT ID
NCT04843878
Status
Completed
Sponsor
University of Pennsylvania

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.