COVID-19 Testing Pilot Study

Study Overview
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Brief Summary
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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.

Official Title
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Feasibility Testing of a New COVID-19 Testing Platform

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

Intervention / Treatment
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* Diagnostic Test: COVID Detect


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The subject must be an adult (age>17) and either sex. 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. Subject must be able to read and write in English. Exclusion Criteria: 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. The subject has previously participated in this research study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Positive<br>Subjects that tested positive for COVID-19 based on the clinical gold standard PCR test. | Diagnostic Test: COVID Detect<br>* The study is determining the efficacy of a new rapid COVID testing method.<br>|
| Negative<br>Subjects that tested negative for COVID-19 based on the clinical gold standard PCR test. | Diagnostic Test: COVID Detect<br>* The study is determining the efficacy of a new rapid COVID testing method.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device Accuracy - Positive and Negative Percentage | 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. | 3 Months | 
| Device Accuracy - False positive and False negative percentage | 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. | 3 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, Detect, Pandemic, Symptomatic, Asymptomatic, Anterior Nares