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| Name | Class |
|---|---|
| Nao Medical Urgent Care | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Testing Done Simple Antigen test in Symptomatic Subjects (Nasal swab) |
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| Testing Done Simple Antigen test in Asymptomatic Subjects (Nasal swab) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Testing Done Simple SARS CoV-2 Antigen Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity | Sensitivity (True Positive Rate) of Testing Done Simple Antigen Test compared to RT-PCR | 15 minutes |
| Specificity | Specificity (True Negative Rate) of Testing Done Simple Antigen Test compared to RT-PCR | 15 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Subject was given a SARS CoV 2 PCR test for any of the following 4 reasons:
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:
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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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nao Medical Urgent Care-Astoria | Queens | New York | 11105 | United States | ||
| Nao Medical Urgent Care-Jackson Heights |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D004194 | Disease |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| Queens |
| New York |
| 11372 |
| United States |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |