Coronavirus Disease-19, COVID-19, COVID-19 Pandemic, COVID-19 Virus Infection, SARS-CoV-2 Infection
Conditions
Keywords
diagnostic kit, diagnostic devices, lateral flow device test
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
Interventions
DIAGNOSTIC_TESTiStatis 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
DIAGNOSTIC_TESTCOVID-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
Sponsors
bioLytical Laboratories
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Intervention model description
Enrolled subjects with anterior nasal swab are tested on both iStatis COVID-19 and RT-PCR.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed