Assessing Performance of the Testing Done Simple Covid 19 Antigen Test

COVID-19 Clinical Trial

Official title:

Assessing Performance of the Testing Done Simple Covid 19 Antigen Test

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05610449
• Other study ID #: 7113211
• Status: Completed
• Start date: November 4, 2022
• Est. completion date: March 29, 2023

Study information

• Verified date: May 2023
• Source: Testing Done Simple
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 171
• Est. completion date: March 29, 2023
• Est. primary completion date: February 17, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

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.

Locations

Country	Name	City	State
United States	Nao Medical Urgent Care-Astoria	Queens	New York
United States	Nao Medical Urgent Care-Jackson Heights	Queens	New York

Sponsors (2)

Lead Sponsor	Collaborator
Testing Done Simple	Nao Medical Urgent Care

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity	Sensitivity (True Positive Rate) of Testing Done Simple Antigen Test compared to RT-PCR	15 minutes
Primary	Specificity	Specificity (True Negative Rate) of Testing Done Simple Antigen Test compared to RT-PCR	15 minutes
Secondary	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