Assessing Performance of the Testing Done Simple Covid 19 Antigen Test

NCT ID: NCT05610449

Last Updated: 2023-05-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 171 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-11-04
• Study Completion Date: 2023-03-29

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.

Conditions

COVID-19

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Testing Done Simple Antigen test in Symptomatic Subjects (Nasal swab)

Testing Done Simple SARS CoV-2 Antigen Test

Intervention Type: DIAGNOSTIC_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)

Testing Done Simple SARS CoV-2 Antigen Test

Intervention Type: DIAGNOSTIC_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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nao Medical Urgent Care

UNKNOWN

Sponsor Role: collaborator

Testing Done Simple

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Nao Medical Urgent Care-Astoria

Queens, New York, United States

Nao Medical Urgent Care-Jackson Heights

Queens, New York, United States

Countries

United States

Other Identifiers

7113211

Identifier Type: -

Identifier Source: org_study_id