COVID-19 Antigen Rapid Test Kit

Study Overview
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Brief Summary
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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.

Official Title
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The Use of SG Diagnostics COVID-19 Antigen Rapid Test Kit for Self-testing as a Method for Reduction SARS-CoV-2

Conditions
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SARS-CoV2 Infection

Intervention / Treatment
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* Diagnostic Test: SG Diagnostics COVID-19 Antigen Rapid Test Kit
* Diagnostic Test: Polymerase chain reaction (PCR) test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult (aged ≥ 18 years) volunteers Exclusion Criteria: Children (aged < 18years)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| COVID-19 positive, asymptomatic<br>COVID-19 positive, asymptomatic (i.e. no current symptoms of COVID-19, confirmed PCR positive for COVID-19) | Diagnostic Test: SG Diagnostics COVID-19 Antigen Rapid Test Kit<br>* SG Diagnostics COVID-19 Antigen Rapid Test Kit (self-use)<br>Diagnostic Test: Polymerase chain reaction (PCR) test<br>* Professional collection of a second swab sample, for confirmation by PCR<br>|
| COVID-19 positive, symptomatic<br>COVID-19 positive, symptomatic (i.e. current symptoms of COVID-19, confirmed PCR positive for COVID-19) | Diagnostic Test: SG Diagnostics COVID-19 Antigen Rapid Test Kit<br>* SG Diagnostics COVID-19 Antigen Rapid Test Kit (self-use)<br>Diagnostic Test: Polymerase chain reaction (PCR) test<br>* Professional collection of a second swab sample, for confirmation by PCR<br>|
| COVID-19 negative<br>COVID-19 negative (i.e. no current or previous symptoms of COVID-19, confirmed PCR negative for COVID-19) | Diagnostic Test: SG Diagnostics COVID-19 Antigen Rapid Test Kit<br>* SG Diagnostics COVID-19 Antigen Rapid Test Kit (self-use)<br>Diagnostic Test: Polymerase chain reaction (PCR) test<br>* Professional collection of a second swab sample, for confirmation by PCR<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SARS-CoV-2, COVID-19, symptoms, test