Assessing Performance of the Testing Done Simple Covid 19 Antigen Test

Testing Done Simple

Status and phase: Completed; Phase 1

Conditions: COVID-19

Treatments: Diagnostic Test: Testing Done Simple SARS CoV-2 Antigen Test

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT05610449

7113211

Details and patient eligibility

About

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.

Full 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.

Enrollment: 171 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

171 participants in 2 patient groups

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

Treatment:

Diagnostic Test: Testing Done Simple SARS CoV-2 Antigen Test

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

Treatment:

Diagnostic Test: Testing Done Simple SARS CoV-2 Antigen Test