NCT05514691 - Evaluation of Clinical Performance and Usability of iStatis COVID-19 Ag Rapid Test at POC | Biotech Hunter

Enrollment

129

Participants

Timeline

Start Date

January 13, 2022

Primary Completion Date

January 21, 2022

Study Completion Date

January 27, 2022

Conditions

COVID-19 Virus InfectionCOVID-19Coronavirus Disease-19COVID-19 PandemicSARS-CoV-2 Infection

Interventions

DIAGNOSTIC_TEST

iStatis COVID-19 Ag Rapid Test

SARS-Cov-2 tests are performed on all appropriate swab samples from each subject enrolled as a comparator test to iStatis Rapid Test

DIAGNOSTIC_TEST

"COVID-19 RT-PCR Test EUA Number: EUA200011, Company: Laboratory Corporation of America (Labcorp)"

The Labcorp COVID-19 RT-PCR or EURORealTime SARS-Cov-2 tests are performed on all appropriate swab samples from each subject enrolled as a comparator test to iStatis Rapid Test

Trial Locations (2)

21075

Centennial Medical Group, Elkridge

33308

Therafirst Medical Center, Fort Lauderdale