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

bioLytical Laboratories

Status: Completed

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

Treatments: Diagnostic Test: iStatis COVID-19 Ag Rapid Test; Diagnostic Test: "COVID-19 RT-PCR Test EUA Number: EUA200011, Company: Laboratory Corporation of America ("Labcorp")

Study type: Interventional

Funder types: Industry

Identifiers

NCT05514691

CLS-011

Details and patient eligibility

About

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.

Full 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

Enrollment: 129 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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129 participants in 2 patient groups

Anterior nasal swab sample tested on iStatis Covid-19 Antigen Testing diagnostic device

Active Comparator group

Description:

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.

Treatment:

Diagnostic Test: iStatis COVID-19 Ag Rapid Test

Anterior nasal swab sample tested with RT-PCR

Active Comparator group

Description:

Another anterior nasal swab sample was collected to be tested with RT-PCR at the central research laboratory.

Treatment:

Diagnostic Test: "COVID-19 RT-PCR Test EUA Number: EUA200011, Company: Laboratory Corporation of America ("Labcorp")