Evaluation of Clinical Performance and Usability of iStatis COVID-19 Ag Rapid Test at POC
Primary Purpose
COVID-19 Virus Infection, COVID-19, Coronavirus Disease-19
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
iStatis COVID-19 Ag Rapid Test
"COVID-19 RT-PCR Test EUA Number: EUA200011, Company: Laboratory Corporation of America ("Labcorp")
Sponsored by
About this trial
This is an interventional diagnostic trial for COVID-19 Virus Infection focused on measuring diagnostic kit, diagnostic devices, lateral flow device test
Eligibility 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
Sites / Locations
- Therafirst Medical Center
- Centennial Medical Group
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Anterior nasal swab sample tested on iStatis Covid-19 Antigen Testing diagnostic device
Anterior nasal swab sample tested with RT-PCR
Arm Description
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.
Another anterior nasal swab sample was collected to be tested with RT-PCR at the central research laboratory.
Outcomes
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05514691
First Posted
August 22, 2022
Last Updated
August 23, 2022
Sponsor
bioLytical Laboratories
1. Study Identification
Unique Protocol Identification Number
NCT05514691
Brief Title
Evaluation of Clinical Performance and Usability of iStatis COVID-19 Ag Rapid Test at POC
Official Title
A Study to Evaluate the Clinical Performance, Usability and Readability of the iStatis COVID-19 Ag Rapid Test Performed With Anterior Nasal Swabs
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
January 13, 2022 (Actual)
Primary Completion Date
January 21, 2022 (Actual)
Study Completion Date
January 27, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
bioLytical Laboratories
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19 Virus Infection, COVID-19, Coronavirus Disease-19, COVID-19 Pandemic, SARS-CoV-2 Infection
Keywords
diagnostic kit, diagnostic devices, lateral flow device test
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Enrolled subjects with anterior nasal swab are tested on both iStatis COVID-19 and RT-PCR.
Masking
Participant
Allocation
Randomized
Enrollment
129 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Anterior nasal swab sample tested on iStatis Covid-19 Antigen Testing diagnostic device
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Anterior nasal swab sample tested with RT-PCR
Arm Type
Active Comparator
Arm Description
Another anterior nasal swab sample was collected to be tested with RT-PCR at the central research laboratory.
Intervention Type
Diagnostic Test
Intervention Name(s)
iStatis COVID-19 Ag Rapid Test
Intervention Description
SARS-Cov-2 tests are performed on all appropriate swab samples from each subject enrolled as a comparator test to iStatis Rapid Test
Intervention Type
Diagnostic Test
Intervention Name(s)
"COVID-19 RT-PCR Test EUA Number: EUA200011, Company: Laboratory Corporation of America ("Labcorp")
Intervention Description
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
Primary Outcome Measure Information:
Title
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.
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Therafirst Medical Center
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
Centennial Medical Group
City
Elkridge
State/Province
Maryland
ZIP/Postal Code
21075
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of Clinical Performance and Usability of iStatis COVID-19 Ag Rapid Test at POC
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