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

Not Applicable

Completed

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

• Registration Number: NCT05514691
• Lead Sponsor: bioLytical Laboratories

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

Study Timeline

• Study Start: 2022-01-13
• Primary Completion: 2022-01-21
• Study Completion: 2022-01-27
• Status Verified: 2022-08
• Study First Submitted: 2022-08-22
• Study First Submitted QC: 2022-08-23
• Last Update Submitted: 2022-08-23
• Study First Posted: 2022-08-24
• Last Update Posted: 2022-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 129

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

Therafirst Medical Center; 🇺🇸 Fort Lauderdale, Florida, United States

Centennial Medical Group; 🇺🇸 Elkridge, Maryland, United States