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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

COVID-19 Virus Infection COVID-19 COVID-19 Pandemic Coronaviridae Infections Coronavirus Disease-19 Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Sars-CoV-2 Infection Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Therafirst Medical Center, Fort Lauderdale, Florida, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

iStatis COVID-19 Ag Rapid Test

Diagnostic 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")

Diagnostic Test

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 outcomes

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.

Time frame: 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.

Sponsors and collaborators

Lead sponsor

bioLytical Laboratories

Industry

Registry information

Official study title

A Study to Evaluate the Clinical Performance, Usability and Readability of the iStatis COVID-19 Ag Rapid Test Performed With Anterior Nasal Swabs

Important dates

Study start: 2022
Primary completion: 2022
Study completion: 2022
First posted: Aug 24, 2022
Registry last updated: Aug 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed