Evaluation of Clinical Performance and Usability of iStatis COVID-19 Ag Rapid Test at POC
NCT ID: NCT05514691
Last Updated: 2022-08-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
129 participants
INTERVENTIONAL
2022-01-13
2022-01-27
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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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.
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
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.
"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
Interventions
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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
"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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
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bioLytical Laboratories
INDUSTRY
Responsible Party
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Locations
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Therafirst Medical Center
Fort Lauderdale, Florida, United States
Centennial Medical Group
Elkridge, Maryland, United States
Countries
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Other Identifiers
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CLS-011
Identifier Type: -
Identifier Source: org_study_id
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