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Recruiting NCT05610449

Assessing Performance of the Testing Done Simple Covid 19 Antigen Test

Conditions: COVID-19

Sex: All
Ages: 18 Years – N/A
Phase: PHASE1
Enrollment: 300
Sponsor: Testing Done Simple

Location: United States

Summary

This study will measure the sensitivity and specificity of the Testing Done Simple severe acute respiratory syndrome (SARS) CoV-2 antigen test in subjects with suspected Covid-19 that present throughout several urgent care clinics. The antigen test performance will be compared to a real-time polymerase chain reaction (RT-PCR) test.

Eligibility Criteria

Inclusion Criteria:Subject was given a SARS CoV 2 PCR test for any of the following 4 reasons:Subject has Covid like symptoms that started within past (7) daysSubject has been exposed to another individual with a known Covid diagnosis or probable Covid diagnosisSubject needs Covid test done for travel, school, work, etcSubject works in a high risk environmentSubject can provide a nasal swab sampleSubject is at least 18 years of ageSubject was given a SARS CoV 2 PCR test on same day participating this studySubject provides informed consentExclusion Criteria:Subject is less than 18 years of ageSubject does not provide consentSubject's Covid 19 related symptom(s) started greater than 7 days from visitAsymptomatic subjects whom have had symptom(s) within past (14) daysSigns of local infection in the area of the faceSubject was not given a SARS CoV 2 PCR test on same day as study

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05610449). StuddyBuddy aggregates publicly available trial information.