NCT05514691

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 129 (actual)
• Sponsor: bioLytical Laboratories · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Conditions

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

Interventions

Type	Name	Description
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
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

Timeline

• Start date: 2022-01-13
• Primary completion: 2022-01-21
• Completion: 2022-01-27
• First posted: 2022-08-24
• Last updated: 2022-08-24

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study