Assessing Performance of the Testing Done Simple Covid 19 Antigen Test

This study will measure the sensitivity and specificity of the Testing Done Simple severe acute respiratory syndrome (SARS) CoV-2 antigen test in subjects with suspected Covid-19 that present throughout several urgent care clinics. The antigen test performance will be compared to a real-time polymerase chain reaction (RT-PCR) test.

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Diagnostic test: Testing Done Simple SARS CoV-2 Antigen Test

Detailed Description

The Testing Done Simple antigen test is a lateral flow immunoassay that detects the presence of the SARS CoV-2 nucleoprotein and is primarily intended for use in an at home setting. The antigen test will be compared to a traditional RT-PCR tested nasal swab specimens. The purpose of study is to measure the performance of the Testing Done Simple test via sensitivity and specificity when compared to the gold-standard RT-PCR test. The test will be administered in symptomatic and asymptomatic subjects and participants will report the days that has passed since their symptom onset. The RT-PCR test will be performed prior to the Testing Done Simple test.

• Study Type: Observational
• Enrollment (Actual): 171
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • Queens, New York, United States, 11105
      • Nao Medical Urgent Care-Astoria
    • Queens, New York, United States, 11372
      • Nao Medical Urgent Care-Jackson Heights

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The cohorts consist of a symptomatic group of patients with Covid related symptoms and an asymptomatic group of patients that may have been exposed to Covid through another person

Description

Inclusion Criteria:

• Subject was given a SARS CoV 2 PCR test for any of the following 4 reasons:

  1. Subject has Covid like symptoms that started within past (7) days
  2. Subject has been exposed to another individual with a known Covid diagnosis or probable Covid diagnosis
  3. Subject needs Covid test done for travel, school, work, etc
  4. Subject works in a high risk environment
• Subject can provide a nasal swab sample
• Subject is at least 18 years of age
• Subject was given a SARS CoV 2 PCR test on same day participating this study
• Subject provides informed consent

Exclusion Criteria:

• Subject is less than 18 years of age
• Subject does not provide consent
• Subject's Covid 19 related symptom(s) started greater than 7 days from visit
• Asymptomatic subjects whom have had symptom(s) within past (14) days
• Signs of local infection in the area of the face
• Subject was not given a SARS CoV 2 PCR test on same day as study

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Testing Done Simple Antigen test in Symptomatic Subjects (Nasal swab)	Diagnostic test: Testing Done Simple SARS CoV-2 Antigen Test; Collections of specimens from subjects presenting with Covid-19 like symptoms or known/suspected exposure to SARS CoV-2 via nasal swabs administered by trained medical personnel.
Testing Done Simple Antigen test in Asymptomatic Subjects (Nasal swab)	Diagnostic test: Testing Done Simple SARS CoV-2 Antigen Test; Collections of specimens from subjects presenting with Covid-19 like symptoms or known/suspected exposure to SARS CoV-2 via nasal swabs administered by trained medical personnel.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity	Sensitivity (True Positive Rate) of Testing Done Simple Antigen Test compared to RT-PCR	15 minutes
Specificity	Specificity (True Negative Rate) of Testing Done Simple Antigen Test compared to RT-PCR	15 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity in Relation to the Time Since Symptom Onset in Symptomatic subjects	Sensitivity of Testing Done Simple Antigen Test according to the days of symptom onset in symptomatic subjects	15 minutes

Collaborators and Investigators

• Sponsor: Testing Done Simple
• Collaborators: Nao Medical Urgent Care
• Investigators: Principal Investigator: Niraj Lodhi, PhD, Testing Done Simple

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2022
• Primary Completion (Actual): February 17, 2023
• Study Completion (Actual): March 29, 2023

Study Registration Dates

• First Submitted: November 7, 2022
• First Submitted That Met QC Criteria: November 7, 2022
• First Posted (Actual): November 9, 2022

Study Record Updates

• Last Update Posted (Actual): May 15, 2023
• Last Update Submitted That Met QC Criteria: May 12, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Diagnosis; Test; Antigen test
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 7113211

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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