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

Sponsor
bioLytical Laboratories (Industry)
Overall Status
Completed
CT.gov ID
NCT05514691
Collaborator
(none)
129
2
2
14
64.5
140.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: iStatis COVID-19 Ag Rapid Test
  • Diagnostic Test: "COVID-19 RT-PCR Test EUA Number: EUA200011, Company: Laboratory Corporation of America ("Labcorp")
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
129 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Enrolled subjects with anterior nasal swab are tested on both iStatis COVID-19 and RT-PCR.Enrolled subjects with anterior nasal swab are tested on both iStatis COVID-19 and RT-PCR.
Masking:
Single (Participant)
Primary Purpose:
Diagnostic
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
Actual Study Start Date :
Jan 13, 2022
Actual Primary Completion Date :
Jan 21, 2022
Actual Study Completion Date :
Jan 27, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Anterior nasal swab sample tested on iStatis Covid-19 Antigen Testing diagnostic device

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.

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

Active Comparator: Anterior nasal swab sample tested with RT-PCR

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

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

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Therafirst Medical Center Fort Lauderdale Florida United States 33308
2 Centennial Medical Group Elkridge Maryland United States 21075

Sponsors and Collaborators

  • bioLytical Laboratories

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
bioLytical Laboratories
ClinicalTrials.gov Identifier:
NCT05514691
Other Study ID Numbers:
  • CLS-011
First Posted:
Aug 24, 2022
Last Update Posted:
Aug 24, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by bioLytical Laboratories
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 24, 2022