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The SG Diagnostics COVID-19 Antigen Rapid Test Kit (Colloidal Gold-Based) is a single-use test kit intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19. This test is intended for use with self-collected nasal swab samples in individuals who are suspected of COVID-19. This test utilizes a lateral flow immunoassay technology for the qualitative detection of spike and nucleocapsid protein antigens of SARS-CoV-2 in individuals with known or suspected COVID-19.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COVID-19 positive, asymptomatic | COVID-19 positive, asymptomatic (i.e. no current symptoms of COVID-19, confirmed PCR positive for COVID-19) |
| |
| COVID-19 positive, symptomatic | COVID-19 positive, symptomatic (i.e. current symptoms of COVID-19, confirmed PCR positive for COVID-19) |
| |
| COVID-19 negative | COVID-19 negative (i.e. no current or previous symptoms of COVID-19, confirmed PCR negative for COVID-19) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SG Diagnostics COVID-19 Antigen Rapid Test Kit | Diagnostic Test | SG Diagnostics COVID-19 Antigen Rapid Test Kit (self-use) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity of SG Diagnostics COVID-19 Antigen Rapid Test Kit | Sensitivity of SG Diagnostics COVID-19 Antigen Rapid Test Kit (self-use) | within 1 day |
| Specificity of SG Diagnostics COVID-19 Antigen Rapid Test Kit | Specificity of SG Diagnostics COVID-19 Antigen Rapid Test Kit (self-use) | within 1 day |
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Inclusion Criteria:
Exclusion Criteria:
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Volunteers with or without COVID-19 symptoms
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maria Sklodowska-Curie Medical Academy | Warsaw | 03-411 | Poland |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| Polymerase chain reaction (PCR) test | Diagnostic Test | Professional collection of a second swab sample, for confirmation by PCR |
|
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |