Evaluation of Clinical Performance and Usability of iStatis COVID-19 Ag Rapid Test at POC

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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A Study to Evaluate the Clinical Performance, Usability and Readability of the iStatis COVID-19 Ag Rapid Test Performed With Anterior Nasal Swabs

Conditions
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COVID-19, COVID-19 Virus Infection, Coronavirus Disease-19, COVID-19 Pandemic, SARS-CoV-2 Infection

Intervention / Treatment
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* Diagnostic Test: iStatis COVID-19 Ag Rapid Test
* Diagnostic Test: COVID-19 RT-PCR Test EUA Number: EUA200011, Company: Laboratory Corporation of America (Labcorp)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant is willing to sign verbal informed consent form Age 18 or older Subject is suspected case of COVID-19 by clinical criteria: a patient with acute respiratory tract infection (sudden onset of at least one of the following: cough, fever, shortness of breath, fatigue, decreased appetite, myalgia) Subjects with above mentioned symptom onset within the 7 days Participant is willing to provide two swabs - one anterior nasal swab sample for iStatis Test and another nasopharyngeal or nasal swab sample for comparator RT-PCR testing Exclusion Criteria: Individuals who presented with 8 or greater days of COVID- 19 Related Symptoms, (Fever, Cough, Fatigue, Decreased Appetite, Shortness of Breath, Myalgia) or postdefervescence and/or convalescence Any reason as identified by the Principal Investigator at the participating site that could disqualify the subject from participation. The reason for exclusion was documented Subject withdraw consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Enrolled subjects with anterior nasal swab are tested on both iStatis COVID-19 and RT-PCR.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Anterior nasal swab sample tested on iStatis Covid-19 Antigen Testing diagnostic device<br>An anterior nasal swab was collected using the swab provided with the iStatis test kit and will be used for the iStatis Covid-19 Antigen Testing at the site. | Diagnostic Test: iStatis COVID-19 Ag Rapid Test<br>* SARS-Cov-2 tests are performed on all appropriate swab samples from each subject enrolled as a comparator test to iStatis Rapid Test<br>|
| Active Comparator: Anterior nasal swab sample tested with RT-PCR<br>Another anterior nasal swab sample was collected to be tested with RT-PCR at the central research laboratory. | Diagnostic Test: COVID-19 RT-PCR Test EUA Number: EUA200011, Company: Laboratory Corporation of America (Labcorp)<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 2 - 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diagnostic kit, diagnostic devices, lateral flow device test