Clinical trial NCT05610449: Assessing Performance of the Testing Done Simple Covid 19 Antigen Test
Official title: Assessing Performance of the Testing Done Simple Covid 19 Antigen Test
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Keywords: Antigen test
Test
Diagnosis
Lead sponsor: Testing Done Simple
Sponsor class: INDUSTRY
Collaborators: name: Nao Medical Urgent Care
First posted: 2022-11-09
Enrollment: 171
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The cohorts consist of a symptomatic group of patients with Covid related symptoms and an asymptomatic group of patients that may have been exposed to Covid through another person

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.

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

Primary outcomes:
measure: Sensitivity
timeFrame: 15 minutes
measure: Specificity
timeFrame: 15 minutes
Secondary outcomes:
measure: Sensitivity in Relation to the Time Since Symptom Onset in Symptomatic subjects
timeFrame: 15 minutes
Other outcomes:
Locations:
city: Queens
country: United States
facility: Nao Medical Urgent Care-Astoria
state: New York
city: Queens
country: United States
facility: Nao Medical Urgent Care-Jackson Heights
state: New York
Study officials:
References: