Clinical trial NCT05514691: Evaluation of Clinical Performance and Usability of iStatis COVID-19 Ag Rapid Test at POC
Official title: A Study to Evaluate the Clinical Performance, Usability and Readability of the iStatis COVID-19 Ag Rapid Test Performed With Anterior Nasal Swabs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19 Virus Infection
COVID-19
Coronavirus Disease-19
COVID-19 Pandemic
SARS-CoV-2 Infection
Keywords: diagnostic kit
diagnostic devices
lateral flow device test
Lead sponsor: bioLytical Laboratories
Sponsor class: INDUSTRY
First posted: 2022-08-24
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Enrolled subjects with anterior nasal swab are tested on both iStatis COVID-19 and RT-PCR.
Primary purpose: DIAGNOSTIC

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

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 2 - 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Lauderdale
country: United States
facility: Therafirst Medical Center
state: Florida
city: Elkridge
country: United States
facility: Centennial Medical Group
state: Maryland
Study officials:
References: