COVID-19 Antigen Rapid Test Kit

• Conditions: SARS-CoV2 Infection
• Interventions: Diagnostic Test: SG Diagnostics COVID-19 Antigen Rapid Test Kit; Diagnostic Test: Polymerase chain reaction (PCR) test

• Registration Number: NCT04889365
• Lead Sponsor: Polish Society of Disaster Medicine

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-05
• Study First Submitted: 2021-05-10
• Study Start: 2021-05-11
• Study First Submitted QC: 2021-05-13
• Last Update Submitted: 2021-05-13
• Study First Posted: 2021-05-17
• Last Update Posted: 2021-05-17
• Primary Completion: 2021-06-30
• Study Completion: 2021-07-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Adult (aged ≥ 18 years) volunteers

Exclusion Criteria

• Children (aged < 18years)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
COVID-19 negative	SG Diagnostics COVID-19 Antigen Rapid Test Kit	COVID-19 negative (i.e. no current or previous symptoms of COVID-19, confirmed PCR negative for COVID-19)
COVID-19 positive, asymptomatic	SG Diagnostics COVID-19 Antigen Rapid Test Kit	COVID-19 positive, asymptomatic (i.e. no current symptoms of COVID-19, confirmed PCR positive for COVID-19)
COVID-19 negative	Polymerase chain reaction (PCR) test	COVID-19 negative (i.e. no current or previous symptoms of COVID-19, confirmed PCR negative for COVID-19)
COVID-19 positive, asymptomatic	Polymerase chain reaction (PCR) test	COVID-19 positive, asymptomatic (i.e. no current symptoms of COVID-19, confirmed PCR positive for COVID-19)
COVID-19 positive, symptomatic	SG Diagnostics COVID-19 Antigen Rapid Test Kit	COVID-19 positive, symptomatic (i.e. current symptoms of COVID-19, confirmed PCR positive for COVID-19)
COVID-19 positive, symptomatic	Polymerase chain reaction (PCR) test	COVID-19 positive, symptomatic (i.e. current symptoms of COVID-19, confirmed PCR positive for COVID-19)

Primary Outcome Measures

Name	Time	Method
Specificity of SG Diagnostics COVID-19 Antigen Rapid Test Kit	within 1 day	Specificity of SG Diagnostics COVID-19 Antigen Rapid Test Kit (self-use)
Sensitivity of SG Diagnostics COVID-19 Antigen Rapid Test Kit	within 1 day	Sensitivity of SG Diagnostics COVID-19 Antigen Rapid Test Kit (self-use)

Trial Locations

Locations (1)

Maria Sklodowska-Curie Medical Academy; 🇵🇱 Warsaw, Poland