A rapid point of care test for the detection of virus particles will be compared to the FDA approved EUA RT-PCR detection standard. The iStatis COVID-19 Ag Rapid Test is intended for rapid point-of-care detection of the SARS-CoV-2 nucleocapsid protein antigen.
Primary Objective: To evaluate the Clinical Performance of iStatis COVID-19 Antigen Test by untrained operators at Point of Care settings that meet requirements for CLIA waived tests. Secondary Objective: To evaluate the performance of iStatis COVID-19 Antigen test around Limit of Detection Samples will be collected in CLIA Waived settings from approximately 200 subjects who present with or are referred for concerns about SARS-CoV-2. The goal is to collect a minimum of N=30 confirmed Covid-19 positive subjects and N=30 confirmed Covid-19 negative subjects of comparable ages, genders, and races. Individual participation only includes sample collection and 1 day visit for the purpose of study
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Enrollment
129
SARS-Cov-2 tests are performed on all appropriate swab samples from each subject enrolled as a comparator test to iStatis Rapid Test
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
Therafirst Medical Center
Fort Lauderdale, Florida, United States
Centennial Medical Group
Elkridge, Maryland, United States
Summary of the iStatis COVID-19 Ag test performance data compared to the comparator EUA RT-PCR test when all data from 4 POC/CLIA sites are combined.
The primary efficacy analyses will be analysis of relative positive percent agreement (PPA) and negative percent agreement (NPA) of the iStatis COVID-19 Antigen test results compared with the participant's RT-PCR results. The overall lower 95% confidence interval will be determined when: Positive Percent Agreement (PPA) = \[TP / (TP + FN)\] x 100, where * TP (true positive) is a positive iStatis test in agreement with prior positive RT-PCR test, and * FN (false negative) is negative iStatis test discordant with prior positive RT-PCR test. Negative Percent Agreement (NPA) = \[TN / (TN + FP)\] x100, where * TN (true negative) is a negative iStatis test in agreement with negative RT-PCR test, and * FP (false positive) is a positive iStatis test discordant with a negative RT-PCR test.
Time frame: 2 - 3 weeks
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