COVID-19 Testing Pilot Study

University of Pennsylvania

Status: Completed

Conditions: Diagnostic Test, Routine; Rapid Coronavirus Test; Diagnoses Disease; Coronavirus

Treatments: Diagnostic Test: COVID Detect

Study type: Observational

Funder types: Other

Identifiers

NCT04843878

844488

Details and patient eligibility

About

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.

Enrollment: 326 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

326 participants in 2 patient groups

Positive

Description:

Subjects that tested positive for COVID-19 based on the clinical gold standard PCR test.

Treatment:

Diagnostic Test: COVID Detect

Negative

Description:

Subjects that tested negative for COVID-19 based on the clinical gold standard PCR test.

Treatment:

Diagnostic Test: COVID Detect