Assessing Performance of the Testing Done Simple Covid 19 Antigen Test

• Sponsor: Testing Done Simple (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05610449
• Collaborator: Nao Medical Urgent Care (Other)
• Enrollment: 300
• Locations: 2
• Arms: 2
• Anticipated Duration (Months): 1.5
• Patients Per Site: 150
• Patients Per Site Per Month: 97.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19	Diagnostic Test: Testing Done Simple SARS CoV-2 Antigen Test	Phase 1

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 300 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Assessing Performance of the Testing Done Simple Covid 19 Antigen Test
• Actual Study Start Date: Nov 4, 2022
• Anticipated Primary Completion Date: Dec 4, 2022
• Anticipated Study Completion Date: Dec 21, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.
Experimental: 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.

Outcome Measures

Primary Outcome Measures

1. Sensitivity [1 month]

   Sensitivity (True Positive Rate) of Testing Done Simple Antigen Test compared to RT-PCR in symptomatic and asymptomatic subjects

2. Specificity [1 month]

   Specificity (True Negative Rate) of Testing Done Simple Antigen Test compared to RT-PCR in symptomatic and asymptomatic subjects

Secondary Outcome Measures

1. Sensitivity in Relation to the Time Since Symptom Onset in Symptomatic subjects [1 month]

   Sensitivity of Testing Done Simple Antigen Test according to the days of symptom onset

2. Sensitivity [1 month]

   Sensitivity (True Positive Rate) of Testing Done Simple Antigen Test compared to RT-PCR in symptomatic subjects

3. Sensitivity [1 month]

   Sensitivity (True Positive Rate) of Testing Done Simple Antigen Test compared to RT-PCR in asymptomatic subjects

4. Specificity [1 month]

   Specificity (True Negative Rate) of Testing Done Simple Antigen Test compared to RT-PCR in symptomatic subjects

5. Specificity [1 month]

   Specificity (True Negative Rate) of Testing Done Simple Antigen Test compared to RT-PCR in asymptomatic subjects

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nao Medical Urgent Care-Astoria	Queens	New York	United States	11105
2	Nao Medical Urgent Care-Jackson Heights	Queens	New York	United States	11372

Sponsors and Collaborators

• Testing Done Simple
• Nao Medical Urgent Care

Investigators

• Principal Investigator: Niraj Lodhi, PhD, Testing Done Simple

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Testing Done Simple
• ClinicalTrials.gov Identifier: NCT05610449
• Other Study ID Numbers: 7113211
• First Posted: Nov 9, 2022
• Last Update Posted: Nov 9, 2022
• Last Verified: Nov 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Testing Done Simple: Antigen test; Test; Diagnosis
• Additional relevant MeSH terms: COVID-19

Study Results

No Results Posted as of Nov 9, 2022