Assessing Performance of the Testing Done Simple Covid 19 Antigen Test

Completed

• Conditions: COVID-19
• Interventions: Diagnostic Test: Testing Done Simple SARS CoV-2 Antigen Test

• Registration Number: NCT05610449
• Lead Sponsor: Testing Done Simple

Brief Summary

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.

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 Timeline

• Study Start: 2022-11-04
• Study First Submitted: 2022-11-07
• Study First Submitted QC: 2022-11-07
• Study First Posted: 2022-11-09
• Primary Completion: 2023-02-17
• Study Completion: 2023-03-29
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-12
• Last Update Posted: 2023-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 171

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Testing Done Simple Antigen test in Symptomatic Subjects (Nasal swab)	Testing Done Simple SARS CoV-2 Antigen Test	-
Testing Done Simple Antigen test in Asymptomatic Subjects (Nasal swab)	Testing Done Simple SARS CoV-2 Antigen Test	-

Primary Outcome Measures

Name	Time	Method
Sensitivity	15 minutes	Sensitivity (True Positive Rate) of Testing Done Simple Antigen Test compared to RT-PCR
Specificity	15 minutes	Specificity (True Negative Rate) of Testing Done Simple Antigen Test compared to RT-PCR

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Nao Medical Urgent Care-Jackson Heights; 🇺🇸 Queens, New York, United States

Nao Medical Urgent Care-Astoria; 🇺🇸 Queens, New York, United States