Coronavirus, Diagnoses Disease, Diagnostic Test, Routine, Rapid Coronavirus Test
Conditions
Keywords
COVID-19, Detect, Pandemic, Symptomatic, Asymptomatic, Anterior Nares
Brief summary
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.
Interventions
DIAGNOSTIC_TESTCOVID Detect
The study is determining the efficacy of a new rapid COVID testing method.
Sponsors
Benjamin S. Abella, MD, MPhil
Marcelo Der Torossian Torres, Ph.D.
Cesar De La Fuente, Ph.D.
University of Pennsylvania
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Device Accuracy - Positive and Negative Percentage | 3 Months | The accuracy of the new prototype testing method will be determined by comparing the prototype's result to the clinical gold standard PCR test. The accuracy will be determined by calculating the percentage of the test's ability to correctly identify both the presence and absence of virus compared to the PCR result for the positive and negative results. |
| Device Accuracy - False positive and False negative percentage | 3 Months | The accuracy of the test will also be determined based on the percentage of false-positives and false-negatives compared to the gold standard clinical PCR test. |
Countries
United States
Outcome results
None listed