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.
Study Type
OBSERVATIONAL
Enrollment
326
The study is determining the efficacy of a new rapid COVID testing method.
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, United States
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.
Time frame: 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.
Time frame: 3 Months
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