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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts 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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Enrolled subjects with anterior nasal swab are tested on both iStatis COVID-19 and RT-PCR.
Primary Purpose
Diagnostic
Masking
Single (Participant)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

More Details

NCT ID
NCT05514691
Status
Completed
Sponsor
bioLytical Laboratories

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.