Evaluation of Clinical Performance and Usability of iStatis COVID-19 Ag Rapid Test at POC

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

  • COVID-19 Virus Infection
  • COVID-19
  • Coronavirus Disease-19
  • COVID-19 Pandemic
  • SARS-CoV-2 Infection

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