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| Name | Class |
|---|---|
| Benjamin S. Abella, MD, MPhil | UNKNOWN |
| Marcelo Der Torossian Torres, Ph.D. | UNKNOWN |
| Cesar De La Fuente, Ph.D. | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Positive | Subjects that tested positive for COVID-19 based on the clinical gold standard PCR test. |
| |
| Negative | Subjects that tested negative for COVID-19 based on the clinical gold standard PCR test. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COVID Detect | Diagnostic Test | The study is determining the efficacy of a new rapid COVID testing method. |
|
| 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 |
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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:
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Subjects will be recruited as they present for treatment at ambulatory Penn testing sites. Subjects who present with symptoms of COVID-19-like illness at the study site as defined in Inclusion Criteria below and have come to the study site for routine evaluation of their condition may be enrolled in this clinical study. Males and females aged >17 years old may be enrolled, and should be represented in proportions representative of the population.
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| Name | Affiliation | Role |
|---|---|---|
| Benjamin S Abella, MD, MPhil | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn Presbyterian Medical Center | Philadelphia | Pennsylvania | 19104 | United States |
No plans to share IPD.
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| ID | Term |
|---|---|
| D018352 | Coronavirus Infections |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
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| D007239 |
| Infections |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |