COVID-19 Antigen Rapid Test Kit (SETCOV)

Polish Society of Disaster Medicine

Status: Unknown

Conditions: SARS-CoV2 Infection

Treatments: Diagnostic Test: Polymerase chain reaction (PCR) test; Diagnostic Test: SG Diagnostics COVID-19 Antigen Rapid Test Kit

Study type: Observational

Funder types: Other

Identifiers

NCT04889365

PTMK_2021_01

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult (aged ≥ 18 years) volunteers

Exclusion criteria

• Children (aged < 18years)

Trial design

200 participants in 3 patient groups

COVID-19 positive, asymptomatic

Description:

COVID-19 positive, asymptomatic (i.e. no current symptoms of COVID-19, confirmed PCR positive for COVID-19)

Treatment:

Diagnostic Test: Polymerase chain reaction (PCR) test

Diagnostic Test: SG Diagnostics COVID-19 Antigen Rapid Test Kit

COVID-19 positive, symptomatic

Description:

COVID-19 positive, symptomatic (i.e. current symptoms of COVID-19, confirmed PCR positive for COVID-19)

Treatment:

Diagnostic Test: Polymerase chain reaction (PCR) test

Diagnostic Test: SG Diagnostics COVID-19 Antigen Rapid Test Kit

COVID-19 negative

Description:

COVID-19 negative (i.e. no current or previous symptoms of COVID-19, confirmed PCR negative for COVID-19)

Treatment:

Diagnostic Test: Polymerase chain reaction (PCR) test

Diagnostic Test: SG Diagnostics COVID-19 Antigen Rapid Test Kit