NCT05514691

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
129

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 13, 2022

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 21, 2022

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 27, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 22, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 24, 2022

Completed
Last Updated

August 24, 2022

Status Verified

August 1, 2022

Enrollment Period

8 days

First QC Date

August 22, 2022

Last Update Submit

August 23, 2022

Conditions

COVID-19 Virus InfectionCOVID-19Coronavirus Disease-19COVID-19 PandemicSARS-CoV-2 Infection

Keywords

diagnostic kitdiagnostic deviceslateral flow device test

Outcome Measures

Primary Outcomes (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.

    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.

    2 - 3 weeks

Study Arms (2)

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

ACTIVE COMPARATOR

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

Anterior nasal swab sample tested with RT-PCR

ACTIVE COMPARATOR

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")

Interventions

iStatis COVID-19 Ag Rapid TestDIAGNOSTIC_TEST

SARS-Cov-2 tests are performed on all appropriate swab samples from each subject enrolled as a comparator test to iStatis Rapid Test

Anterior nasal swab sample tested on iStatis Covid-19 Antigen Testing diagnostic device
"COVID-19 RT-PCR Test EUA Number: EUA200011, Company: Laboratory Corporation of America ("Labcorp")DIAGNOSTIC_TEST

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

Anterior nasal swab sample tested with RT-PCR

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Subject withdraw consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Therafirst Medical Center

Fort Lauderdale, Florida, 33308, United States

Location

Centennial Medical Group

Elkridge, Maryland, 21075, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: Enrolled subjects with anterior nasal swab are tested on both iStatis COVID-19 and RT-PCR.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2022

First Posted

August 24, 2022

Study Start

January 13, 2022

Primary Completion

January 21, 2022

Study Completion

January 27, 2022

Last Updated

August 24, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

US(2)