Evaluation of Clinical Performance and Usability of iStatis COVID-19 Ag Rapid Test at POC
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Detailed Description
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 Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: Anterior nasal swab sample tested on iStatis Covid-19 Antigen Testing diagnostic device 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
SARS-Cov-2 tests are performed on all appropriate swab samples from each subject enrolled as a comparator test to iStatis Rapid Test
|
Active Comparator: Anterior nasal swab sample tested with RT-PCR 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")
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
|
Outcome Measures
Primary Outcome Measures
- 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. [2 - 3 weeks]
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.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Therafirst Medical Center | Fort Lauderdale | Florida | United States | 33308 |
2 | Centennial Medical Group | Elkridge | Maryland | United States | 21075 |
Sponsors and Collaborators
- bioLytical Laboratories
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CLS-011